Prosthesis, tracheal, expandable: medical device reports filed with FDA

3,011 reports carry this product code, 1996–2026; 12 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

3,011
reports with this product code: 0% of all MAUDE reports; 72
reports, 12 months to August 2026: 54 in the 12 months before; 52.9%
classified as malfunction: 62.3% across all reports; 3.6%
classified as death, as reported: 0.9% across all reports

Product code JCT is FDA's classification for "Prosthesis, tracheal, expandable" (general, Plastic Surgery panel), a class 2 device. 3,011 medical device reports carry this product code, 0% of the MAUDE database, from October 1996 to August 2026.

72 reports arrived in the 12 months to August 2026, up 33% from 54 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (52.9%), injury (42.3%) and death (3.6%). 12 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Ultraflex Tracheobronchial	690	51	0.3%	59.5%
Fluency Plus Tracheobronchial Stent Graft	312	0	0%	90.7%
Icast Covered Stent	244	0	9.8%	42.9%
Atrium Icast Covered Stent	207	0	0.5%	2.4%
WALLSTENT Endoprosthesis	48	14	1.4%	57.7%
GORE VIABAHN Endoprosthesis	36	18	5.8%	23.5%
Ultraflex	23	0	4.5%	38.9%
Wallstent Enteral Endoprosthesis	14	0	10.5%	23.5%
Wallstent Biliary	8	5	0.6%	72.7%
Advanta V12 Covered Stent	3	0	12.6%	37.9%
Wallstent Endoprosthesis With Unistep Plus Delivery System	1	0	2.9%	36.9%
Wallstent Rx Biliary Endoprosthesis	1	0	0.5%	36.9%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Atrium Medical	808	26.8%
Boston Scientific - Galway	631	21%
Boston Scientific Ireland	122	4.1%
Angiomed & Medizintechnik Kg	115	3.8%
W L Gore & Associates	50	1.7%
Bard Peripheral Vascular	25	0.8%
Merit Medical Systems	18	0.6%
Ev3	10	0.3%
Bard	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death3.6%108

Injury42.3%1,273

Malfunction52.9%1,594

Other0.8%23

Not given0.4%13

Who filed

Manufacturer report95.7%2,881

Voluntary report1.7%52

User facility report0%0

Distributor report0%0

Not given2.6%78

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Activation, positioning or separation problem	420	13.9%
Positioning failure	404	13.4%
Breakthe device broke	234	7.8%
Fracturea broken bone	178	5.9%
Positioning problem	166	5.5%
Detachment of device component	159	5.3%
Difficult to removethe device was hard to remove	139	4.6%
Replace	138	4.6%
Material deformation	123	4.1%
Activation failure	121	4%
Migration or expulsion of device	114	3.8%
Difficult or delayed positioning	110	3.7%
Device dislodged or dislocated	97	3.2%
Device remains implanted	71	2.4%
Explanted	66	2.2%
Material separation	66	2.2%
Sticking	64	2.1%
Failure to advance	63	2.1%
Device, removal of (non-implant)	60	2%
Occlusion within devicethe device blocked	56	1.9%

Questions about prosthesis, tracheal, expandable reports

What is product code JCT?

FDA's classification code for "Prosthesis, tracheal, expandable", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,011 reports through August 2026, 72 of them in the latest 12 months.

Which brands appear most often?

Ultraflex Tracheobronchial (690), Fluency Plus Tracheobronchial Stent Graft (312), Icast Covered Stent (244), Atrium Icast Covered Stent (207) and WALLSTENT Endoprosthesis (48). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.