ZILVER VENA VENOUS SELF EXPANDING STENT
Report
- Report Number
- 3001845648-2023-00437
- Event Type
- Malfunction
- Date Received
- June 2, 2023
- Date of Event
- January 27, 2022
- Report Date
- June 22, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # P200023. INVESTIGATION IS STILL PENDING. A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # (B)(4). OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS REVIEW PRIOR TO DISTRIBUTION ALL ZILVER VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0047) STATES THE FOLLOWING: ¿THE ZILVER VENA VENOUS STENT IS INTENDED FOR USE IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC VENOUS OUTFLOW OBSTRUCTION¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU OR LABEL. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. THE INSTRUCTIONS FOR USE STATES THAT THE DEVICE IS INTENDED FOR USE IN THE ILIOFEMORAL VEINS HOWEVER FROM THE INFORMATION PROVIDED THE DEVICE WAS USED IN THE COMMON ILIAC ARTERIES. CONFIRMATION OF COMPLAINT COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY OF INVESTIGATION THE COMPLAINT WAS RAISED FROM LITERATURE PAPER MITRESKI ET AL ¿STABILISE; TREATMENT OF AORTIC DISSECTION, A SINGLE CENTRE EXPERIENCE¿. THE PAPER REPORTED THE OFF LABEL USE OF 08 ZILVER VENA STENTS IN THE COMMON ILIAC ARTERIES. THERE WERE NO ADVERSE EFFECTS REPORTED AS A RESULT OF THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE OF OFF LABEL USE IN THE COMMON ILIAC ARTERIES. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
(B)(6) 2022, STABILISE; TREATMENT OF AORTIC DISSECTION, A SINGLE CENTRE EXPERIENCE. SINGLE CENTRE RETROSPECTIVE ANALYSIS FROM JANUARY 2011 TO JANUARY 2021 USING THE STABILISE TECHNIQUE, WHICH UTILISES BALLOON ASSISTANCE TO FACILITATE INTIMAL DISRUPTION AND PROMOTE AORTIC RELAMINATION. WHEN DISSECTION CONTINUES INTO THE COMMON ILIAC ARTERIES. THESE ARE TREATED USING LARGE SELF-EXPANDING NITINOL STENTS (ZILVER® VENA; COOK). BALLOON DILATATION WITHIN ILIAC ARTERIES IS ACHIEVED EITHER WITH AN ANGIOPLASTY BALLOON SIZED TO THE TOTAL ILIAC DIAMETER OR GENTLE PARTIAL INFLATION OF THE 32 MM CODA® BALLOON. OFF LABEL USE: PLACEMENT IN THE COMMON ILIAC ARTERIES PER IFU ZILVER VENA STENTS ARE INDICATED FOR USE IN THE ILIOFEMORAL VEINS, FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION. PATIENT/EVENT INFO - NOTES: PATIENT INFO: AVERAGE AGE 61. 16 PATIENTS: 11 MALES (69%).
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE (B)(6) 2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1623049 | ZILVER VENA VENOUS SELF EXPANDING STENT | STENT, ILIAC VEIN | QAN | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male |