ZILVER 635 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2021-00508
- Event Type
- Malfunction
- Date Received
- June 22, 2021
- Date of Event
- May 19, 2021
- Report Date
- August 20, 2021
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- UDI-DI
- 10827002333335
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PMA/510(K) #: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #: P050017/S002 AND S003. THE ZIV6-125-10-8.0 DEVICE OF LOT NUMBER C1804603 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 28TH JUNE 2021. ON EVALUATION OF THE DEVICE, DAMAGED WAS OBSERVED ON THE DISTAL END OF THE OUTER SHEATH. THE INNER CATHETER AT DISTAL WHITE TIP WAS KINKED AND PERFORATED. THE STENT AT THE DISTAL END OF THE OUTER SHEATH WAS DAMAGED. THE DEVICE FLUSHED AS EXPECTED. A 0.035 INCH WIRE GUIDE COULD NOT PASS THE KINK ON THE INNER CATHETER (APPROX. 2.5CM FROM DISTAL TIP). PRIOR TO DISTRIBUTION ZIV6-125-10-8.0 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ZIV6-125-10-8.0 OF LOT NUMBER C1804603 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1804603. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿THE ZILVER VASCULAR STENT IS INTENDED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. A DEFINITIVE ROOT CAUSE OF OFF- LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE USER USED THIS DEVICE FOR THE TREATMENT OF A LESION ON THE HEPATIC PORTAL VEIN. THIS IS CONSIDERED OFF LABEL USE. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE USER HAD NOT CHECKED THE DEVICE WHEN OPENED THE PACKAGING , IT WAS FOUND THAT STENT COULD NOT DEPLOYED AFTER THE DELIVERY SYSTEM REACHED INTO THE LESION(HEPATIC PORTAL VEIN), THEN THE USER WITHDRAW THE DELIVERY SYSTEM AND FOUND THAT A WIRE OF STENT PUNCTURED THE SHEATH . THEN THE USER REPLACED ANOTHER NEW STENT TO COMPLETED THIS PROCEDURE SUCCESSFULLY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
SUPPLEMENTAL REPORT REQUIRED: DEVICE EVALUATED ON 28-JUN-21: "DISTAL END OF OUTER SHEATH DAMAGED. INNER CATHETER KINKED AND PERFORATED. STENT DAMAGED".
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 938902 | ZILVER 635 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | C1804603 | 10827002333335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |