ADVANTA V12 COVERED STENT
Report
- Report Number
- 3011175548-2025-000010
- Event Type
- Malfunction
- Date Received
- September 10, 2025
- Date of Event
- August 11, 2025
- Report Date
- December 16, 2025
- Manufacturer
- ATRIUM MEDICAL CORPORATION
- Product Code
- NIO
- UDI-DI
- 00650862853643
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION SECTION: D9, H3, H6- TYPE OF INVESTIGATION THE PRODUCT IN QUESTION WAS RETURNED AND DID NOT SUPPLY ANY NEW INFORMATION AS THE IMAGES ORIGINALLY SUBMITTED WITH THE REPORTED COMPLAINT PROVIDED SUFFICIENT EVIDENCE REGARDING THE NATURE OF THE COMPLAINT.
DUE TO CHARACTER RESTRICTIONS IN BLOCK E1. EVENT SITE NAME: (B)(6). UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED ON THE SOUTH AFRICA MARKET ON A DEVICE THAT IS DISTRIBUTED EXCLUSIVELY OUTSIDE OF THE USA. THEREFORE, NO GUDID INFORMATION EXISTS. UDI INFORMATION PROVIDED IN D4 IS FOR THE ADVANTA STENT (OUS DEVICE). IT IS A SIGNIFICANTLY SIMILAR DEVICE TO ICAST STENT WHICH IS SOLD IN THE USA UNDER PRIMARY DI NUMBER (B)(4), PREMARKET SUBMISSION NUMBER P120003.
UPDATED SECTION: B5, B6, B7, D10, E2, E3, E4, H6- HEALTH EFFECT ¿ IMPACT CODES, G2.
ADDITIONAL SECTION- H6. THE CUSTOMER REPORTED THAT THE ADVANTA V12 STENT WAS REMOVED FROM THE INTERIOR STERILE PACKAGE/CONTAINER, AND THE GUIDEWIRE LUMEN PORT WAS FLUSHED. AS IT WAS IN THE PROCESS OF BEING FLUSHED IT WAS NOTICED THAT THE TIP OF THE CATHETER THAT IS CARRYING THE STENT FELL OFF. THE DEVICE IN QUESTION WAS NOT RETURNED HOWEVER IMAGES OF THE DEVICE WERE PROVIDED. A REVIEW OF THE IMAGES SHOW THAT THE BALLOON AND STENT THAT HAD NOT BEEN DEPLOYED HAD BEEN SEPARATED FROM THE CATHETER CONFIRMING THE COMPLAINT. BASED ON THE IMAGES PROVIDED HOWEVER THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS PROVIDED IN THIS CONDITION. THE CATHETER SHAFT HAS BEEN STRETCHED AND ELONGATED TO THE POINT OF FAILURE. IT IS VERY EVIDENT BASED ON THE RETURNED DEVICE IMAGES THAT THE BALLOON AND STENT WERE UNDER A TENSILE LOAD AFTER BEING REMOVED FROM THE PRODUCT PACKAGING. A PRODUCT IN THIS CONDITION WOULD NOT HAVE BEEN PACKAGED AS EVERY DEVICE IS PLACED IN THE PACKAGE UNDER A VENTED HOOD AND INSPECTED PRIOR TO BEING PLACED INTO THE PRODUCT TRAY DURING THE PACKAGING PROCESS. THERE ARE ALSO NO OPPORTUNITIES DURING THE PROCESS OF PACKAGING THAT WOULD CREATE A TENSILE LOAD ON THE CATHETER DURING PACKAGING. THERE IS ALSO NO OPPORTUNITIES OF TENSILE LOADING WHILE REMOVING THE CATHETER FROM THE V12 COVERED STENT PACKAGING. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT THERE WERE NO NON-CONFORMANCES NOTED AND THE PRODUCT MET ALL QUALITY AND PERFORMANCE REQUIREMENTS. THERE IS NO INDICATION THAT A DESIGN, MANUFACTURING SPECIFICATION, TEST METHOD, MANUFACTURING PROCESS, EQUIPMENT OR RAW MATERIAL WAS THE CAUSE OF THE COMPLAINT. A RECURRING LOT NUMBER QUERY WAS CONDUCTED FOR L/N 505029 AND THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE PRODUCTION LOT OF FINISHED GOODS. A HISTORICAL REVIEW OF CAPA, NCRS AND COMPLAINTS WAS COMPLETED, WHICH DID NOT IDENTIFY ANY ISSUES DIRECTLY RELATED TO THIS COMPLAINT. A RISK REVIEW FOUND THAT THE RISK MANAGEMENT DOCUMENTS FOR THIS PRODUCT ADEQUATELY ADDRESS THE REPORTED DEFECT AND THE SEVERITY AND ANTICIPATED OCCURRENCE LEVEL ARE APPROPRIATE. BASED ON THE INFORMATION PROVIDED AND REVIEW OF THE DEVICE IMAGES AS WELL AS THE REVIEW OF THE DEVICE HISTORY RECORDS THERE IS NO INDICATION THAT THE PRODUCT IN QUESTION WAS DEFECTIVE WHEN MANUFACTURED. THERE IS EVIDENCE OF A TENSILE LOAD HAVING BEEN APPLIED TO THE CATHETER SHAFT WHERE THE BALLOON BROKE OFF, AS EVIDENCED BY THE NECKED DOWN CATHETER SHAFT NEAR THE BREAKING POINT. THIS TENSILE LOAD IS CONSIDERED TO HAVE BEEN THE CAUSE OF THE DETACHMENT. IT IS NOT KNOWN WHEN OR WHY THIS TENSILE LOAD WAS APPLIED TO THE DELIVERY SYSTEM BASED ON THE DEVICE EVALUATION AND USER FEEDBACK. AS SUCH THE ROOT CAUSE IS IMPOSSIBLE TO DEFINE. THERE IS A POSSIBILITY THAT THE STENT WAS MISTAKEN TO BE A STENT PROTECTOR AND UPON PULLING ON THE STENT THE CATHETER BROKE, BUT THIS WAS UNABLE TO BE CONFIRMED.
N/A.
DURING THE PROCEDURE, WHILE FLUSHING THE GUIDEWIRE LUMEN PORT, IT WAS OBSERVED THAT THE TIP OF THE CATHETER THAT IS CARRYING THE STENT FELL OFF.
IT WAS REPORTED THAT THE DEVICE WAS NOT BEING USED ON THE PATIENT. COMPETITOR¿S STENT WAS USED TO CONTINUE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2517937 | ADVANTA V12 COVERED STENT | STENT, ILIAC | NIO | ATRIUM MEDICAL CORPORATION | 85364 | 505029 | 00650862853643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |