ICAST COVERED STENT SYSTEM, 9MMX59MMX120CM
Report
- Report Number
- 3011175548-2026-000002
- Event Type
- Malfunction
- Date Received
- March 17, 2026
- Date of Event
- February 26, 2026
- Report Date
- May 19, 2026
- Manufacturer
- ATRIUM MEDICAL CORPORATION
- Product Code
- PRL
- UDI-DI
- 00650862429596
- PMA / PMN Number
- P120003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DUE TO CHARACTER RESTRICTIONS IN FOLLOWING SECTION. D4 FIELD: ADDITIONAL TWO STENT INVOLVED IN THE EVENT WITH LOT NO'S 42759 AND 42959. IT IS UNKNOWN CURRENTLY WHICH OF THE STENT IS BEEN IMPLANTED. E1: EVENT SITE NAME: (B)(6) HOSPITAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
DUE TO CHARACTER RESTRICTIONS IN FOLLOWING SECTION. D10: 8FR TERUMO DESTINATION, 18FR MEDTRONIC APTUS HELI-FX SHEATH. RELATED MDRS: 3011175548-2026-0000028, 3011175548-2026-0000033. UPDATED FIELDS: A2, B5, D4 (UDI, SERIAL).
A COMPLAINT WAS RECEIVED FOR AN ICAST COVERED STENT REPORTING THAT DURING A GORE TAMBE PROCEDURE INVOLVING STENTING OF THE CELIAC, SUPERIOR MESENTERIC, AND BILATERAL RENAL ARTERIES, THE STENT DISLODGED FROM THE BALLOON CATHETER DURING ADVANCEMENT. THE EVENT OCCURRED ON THREE SEPARATE ATTEMPTS. TWO STENTS DISLODGED AND WERE RETRIEVED WITHIN THE INTRODUCER SHEATH, AND ONE STENT DISLODGED AND WAS ULTIMATELY IMPLANTED. NO DEVICES WERE RETURNED FOR EVALUATION, AND NO PROCEDURAL IMAGES WERE PROVIDED. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED THROUGH DIRECT PRODUCT INSPECTION OR VISUAL EVIDENCE. AN INVESTIGATION WAS CONDUCTED, INCLUDING REVIEW OF THE DEVICE HISTORY RECORDS (DHR), COMPLAINT HISTORY AND TRENDING, CAPA AND NONCONFORMANCE RECORDS, RISK MANAGEMENT DOCUMENTATION, AND PRODUCT LABELING. THE DHR REVIEW CONFIRMED THAT THE DEVICES WERE MANUFACTURED AND RELEASED IN ACCORDANCE WITH ESTABLISHED SPECIFICATIONS AND QUALITY REQUIREMENTS. STENT RETENTION TESTING DEMONSTRATED VALUES EXCEEDING THE MINIMUM SPECIFICATION OF GREATER THAN OR EQUAL TO 5.5 N, AND INTRODUCER SHEATH COMPATIBILITY TESTING CONFIRMED SUCCESSFUL DEVICE PASSAGE WITHOUT STENT DISLODGEMENT OR MOVEMENT DURING QUALIFICATION TESTING. A REVIEW OF COMPLAINT DATA IDENTIFIED NO SIMILAR COMPLAINTS ASSOCIATED WITH THE REPORTED LOTS, AND OVERALL COMPLAINT RATES FOR THIS FAILURE MODE REMAIN LOW AND WITHIN EXPECTED LEVELS, WITH NO ADVERSE TRENDS OR EXCURSIONS OBSERVED. CAPA AND NONCONFORMANCE REVIEWS DID NOT IDENTIFY ANY SYSTEMIC ISSUES OR PRODUCT RELATED DEFICIENCIES THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT IS ASSOCIATED WITH THE OPERATIONAL CONTEXT OF THE PROCEDURE. INFORMATION OBTAINED DURING THE INVESTIGATION INDICATES THAT THE STENTS WERE LIKELY ADVANCED VIA A FEMORAL UP AND OVER APPROACH INTO A GORE TAMBE ENDOGRAFT. THIS APPROACH WOULD REQUIRE NAVIGATION THROUGH AN APPROXIMATE 180 DEGREE ANGULATION RELATIVE TO THE TARGET VESSELS. PUBLISHED INFORMATION FOR THE TAMBE SYSTEM INDICATES THAT A BRACHIAL APPROACH IS RECOMMENDED DUE TO THE SEVERE ANGULATION ASSOCIATED WITH FEMORAL ACCESS. THE ACUTE ANGLE ENCOUNTERED DURING THE PROCEDURE LIKELY INCREASED RESISTANCE DURING ADVANCEMENT AND CONTRIBUTED TO STENT DISLODGEMENT. THE DEVICE MET ALL SPECIFICATIONS AND PERFORMANCE REQUIREMENTS, AND NO EVIDENCE OF A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WAS IDENTIFIED. THE EVENT IS CONSIDERED CONSISTENT WITH A USE RELATED ISSUE DUE TO PROCEDURAL TECHNIQUE AND ANATOMICAL CHALLENGES. THE REPORTED EVENT, STENT DISLODGEMENT FROM THE CATHETER IN THE SHEATH REQUIRING ADDITIONAL INTERVENTION, IS A KNOWN RISK ASSOCIATED WITH THE DEVICE AND IS ADDRESSED WITHIN THE PRODUCT RISK MANAGEMENT DOCUMENTATION. THE SEVERITY AND OCCURRENCE OF THIS EVENT REMAIN CONSISTENT WITH ESTABLISHED RISK ASSESSMENTS. LABELING, INCLUDING WARNINGS AND PRECAUTIONS, PROVIDES APPROPRIATE GUIDANCE REGARDING SHEATH COMPATIBILITY, AVOIDANCE OF EXCESSIVE RESISTANCE, AND PROPER USE TECHNIQUES.
IT WAS REPORTED THAT WHILE ATTEMPTING TO ADVANCE THE ICAST STENTS, THE STENT DISLODGED FROM THE BALLOON. TWO STENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT AFTER DISLODGING AND TRAVELING INTO THE SHEATH. THE THIRD STENT WAS IMPLANTED IN THE PATIENT. THERE WAS NO PATIENT HARM REPORTED.
THE STENT DISLODGED WHILE ADVANCING THROUGH THE SHEATH AND THE STENT WAS SUCCESSFULLY REMOVED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 109145 | ICAST COVERED STENT SYSTEM, 9MMX59MMX120CM | ILIAC COVERED STENT, ARTERIAL | PRL | ATRIUM MEDICAL CORPORATION | 42959 | 521342 | 00650862429596 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female |