ZILVER 635 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2021-00182
- Event Type
- Malfunction
- Date Received
- March 11, 2021
- Date of Event
- January 28, 2021
- Report Date
- April 2, 2021
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- UDI-DI
- 10827002334257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
PMA/510(K) #: P050017/S002 AND S003. ANNEX G: G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. DEVICE EVALUATION: THIS COMPLAINT IS RELATED TO PR 321570 (EMDR 3001845648-2021-001810). THIS FILE INVESTIGATES THE REPORTED EVENT WHEREBY ¿THE SURFACE SHEATH PEELED OFF¿. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO PR 321570. THE ZIV6-125-6-4.0 DEVICE OF LOT NUMBER C1662789 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 18 FEBRUARY 2021. ON EVALUATION OF THE DEVICE THE OUTER SHEATH WAS OBSERVED TO HAVE PULLED THROUGH THE WHITE CONNECTOR CAP ON THE DEVICE AND HAD SEPARATED FROM THE HANDLE. THE DEVICE FLUSHED AS EXPECTED AND A 0.035¿ WIRE GUIDE PASSED THROUGH THE DEVICE WITHOUT ISSUE. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZIV6-125-6-4.0 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 ZIV6-125-6-4.0 OF LOT NUMBER C1662789 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 C1662789. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0041-7) STATES THE FOLLOWING: ¿INTENDED USE THE PRODUCT IS INTENDED FOR USE IN THE ILIAC ARTERIES FOR THE FOLLOWING TREATMENTS: ¿ ATERIOSCLEROTIC STENOSIS. ¿ TOTAL OCCLUSIONS THAT HAVE BEEN RECANALIZATED.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF-LABEL USE WAS IDENTIFIED IN THE LABORATORY. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE DEVICE WAS USED IN THE SUPERIOR MESENTERIC ARTERY (SMA) AS PER THE IFU, THE DEVICE IS INTENDED FOR USE IN THE ILIAC ARTERIES. IT IS POSSIBLE THAT THE USE OF THE DEVICE IN A NON-INDICATED LOCATION MAY HAVE CAUSED AND/OR CONTRIBUTED TO THE OUTER SHEATH SEPARATING FROM THE HANDLE DURING ATTEMPTED DEPLOYMENT. IT IS NOT POSSIBLE TO STATE HOW THE DEVICE WILL PERFORM WHEN USED OUTSIDE OF ITS VALIDATED STATE. SUMMARY: 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.
PMA/510(K) #: P050017/S002 AND S003(B)(4)INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
THIS IS A COMPLETE REPORT. THE INVESTIGATION WAS COMPLETED ON 02-APR-2021. THE RESULTS AND CONCLUSIONS ARE OUTLINED IN SECTION H OF THIS REPORT.
THE PATIENT UNDERWENT A STENT IMPLANTATION OF SUPERIOR MESENTERIC ARTERY . AFTER THE DELIVERY SYSTEM ADVANCED INTO THE TARGET LOCATION, THE USER TRY TO PULL BACK THE HANDLE TO THE HUB TO DEPLOY THE STENT BUT THE STENT HAVE NOT DEPLOYED AND THE SURFACE OF SHEATH PEEL OFF. THEN THE USER REMOVED THE DEVICE AND REPLACED ANOTHER NEW STENT WITH RPN ZIV6-125-6-6.0 TO FINISHED THE PROCEDURE SUCCESSFULLY.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."PATIENT/EVENT INFO - NOTES: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES, SEE ATTACHED PHOTO AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT STAGE DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)?J&J'S GUIDE CATHETER (8F MPA1 70CM) WHAT WAS THE TARGET LOCATION FOR THE STENT? SUPERIOR MESENTERIC ARTERY WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? NO WAS THE DEVICE USED PERCUTANEOUSLY? YES WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? YES, WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES, WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? N/A DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? HPWA-35-260 DID THE PATIENT EXHIBIT DIFFICULT OR ALTERED ANATOMY (IF ALTERED PLEASE SPECIFY HOW IT IS ALTERED)? NO WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NO HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? N/A WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? IPSILATERAL IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? YES WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY? N/A WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? NO WAS THE HANDLE PULLED TOWARDS THE HUB DURING DEPLOYMENT? YES, WAS THE DELIVERY SYSTEM PUSHED DURING DEPLOYMENT? NO WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? NO IF NO, PLEASE DETAIL ANY DIFFICULTY EXPERIENCED DURING DEPLOYMENT: __________________THE SHEATH FAIL TO PULL BACK AND THE STENT TOTALLY COULD NOT RELEASED. WHAT ARTERY WAS THE STENT PLACED IN? SUPERIOR MESENTERIC ARTERY WAS THE STENT FULLY DEPLOYED FROM THE DELIVERY SYSTEM PRIOR TO REMOVAL OF THE DELIVERY SYSTEM? NO DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS? NO IF YES, PLEASE SPECIFY: __________________________ DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO WHAT INTERVENTION (IF ANY) WAS REQUIRED?N/A WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME PROCEDURE WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? NO
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362559 | ZILVER 635 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | C1662789 | 10827002334257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |