ZILVER 518 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2022-00067
- Event Type
- Injury
- Date Received
- February 4, 2022
- Report Date
- June 3, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA # - P050017/S002 AND S003. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA # - (B)(4). 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. DEVICE EVALUATION: THE ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT DEVICE OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT 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. IT SHOULD BE NOTED THAT RESTENOSIS OF THE STENTED ARTERY IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE INSTRUCTIONS FOR USE (IFU0058). THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT PATIENT ANATOMY AND/OR THE STENT ITSELF. AS MENTIONED ABOVE RESTENOSIS OF THE STENTED ARTERY IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE IFU. HOWEVER, THERE IS NO EVIDENCE WITHIN THE JOURNAL ARTICLE TO SUGGEST ANY DEVICE MALFUNCTION OR DETERIORATION IN DEVICE CHARACTERISTICS. AS PER CER (D00309345) "OCCLUSION IS CURRENTLY DISCLOSED UNDER THE FOLLOWING POTENTIAL ADVERSE EVENTS LISTED IN THE IFU: RESTENOSIS/ABRUPT STENT CLOSURE/FRACTURE/EMBOLIZATION. FOR CLARIFICATION PURPOSES AND TO ALIGN WITH THE POTENTIAL ADVERSE EVENTS IN OTHER VASCULAR STENT IFUS, OCCLUSION WILL BE ADDED TO THE IFU IN A FUTURE UPDATE." AS PER MEDICAL ADVISOR "MALE (MAJOR ADVERSE LIMB EFFECTS) WAS DEFINED AS MAJOR AMPUTATION OR ANY REINTERVENTION (SURGICAL OR ENDOVASCULAR). FROM TABLE III IT CAN BE SEEN THAT MOST, BUT NOT ALL OF THE RESTENOSIS OR RE-OCCLUSION CASES HAD A MALE. (IT IS POSSIBLE THAT SOME OF THE RESTENOSIS CASES THAT WERE PICKED UP ON US BUT NOT CLINICALLY SIGNIFICANT DID NOT REQUIRE A REINTERVENTION BUT THIS WOULD BE IN THE MINORITY). " SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER RESTENOSIS AND RE-OCCLUSION OCCURRED IN THE BNS GROUP. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
SOGA 2016, UNKNOWN ZILVER FLEX AND PROPENSITY SCORE ANALYSIS COMPARING CLINICAL OUTCOMES OF DRUG-ELUTING VS BARE NITINOL STENTS IN FEMOROPOPLITEAL LESIONS. THE BNS GROUP WAS TAKEN FROM THE REAL-FP (RETROSPECTIVE MULTICENTER ANALYSIS FOR FEMOROPOPLITEAL DISEASE) REGISTRY APPROVED BY THE INSTITUTIONAL REVIEW BOARDS AT ALL 13 PARTICIPATING CARDIOVASCULAR AND VASCULAR INSTITUTIONS IN (B)(6) ((B)(4)). DATA FROM THESE PATIENTS WERE USED AS A HISTORICAL CONTROL. THE REGISTRY INCLUDED 2499 LIMBS WERE ELIGIBLE FOR THIS ANALYSIS. RESTENOSIS AND RE-OCCLUSION OCCURRED IN THE BNS GROUP.
SOGA 2016, UNKNOWN ZILVER FLEX AND PROPENSITY SCORE ANALYSIS COMPARING CLINICAL OUTCOMES OF DRUG-ELUTING VS BARE NITINOL STENTS IN FEMOROPOPLITEAL LESIONS. THE BNS GROUP WAS TAKEN FROM THE REAL-FP (RETROSPECTIVE MULTICENTER ANALYSIS FOR FEMOROPOPLITEAL DISEASE) REGISTRY APPROVED BY THE INSTITUTIONAL REVIEW BOARDS AT ALL 13 PARTICIPATING CARDIOVASCULAR AND VASCULAR INSTITUTIONS IN (B)(6) ((B)(4)). DATA FROM THESE PATIENTS WERE USED AS A HISTORICAL CONTROL. THE REGISTRY INCLUDED 2499 LIMBS WERE ELIGIBLE FOR THIS ANALYSIS. RESTENOSIS AND RE-OCCLUSION OCCURRED IN THE BNS GROUP.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE KAMIOKA STUDY RECEIVED REFERENCED WITHIN THE COMPARISON PAPER SOGA 2016 ON 08-FEB-22. RPN, QUANTITY AND EVENT DESCRIPTION UPDATED. ADDITIONAL INFO RECEIVED 08-FEB-22 "KAMIOKA 2017 (REAL-FP STUDY): WE RETROSPECTIVELY ANALYZED THE REMAINING 337 PATIENTS (371 LIMBS) UNDERGOING SUCCESSFUL EVT FOR DE NOVO FP LESIONS AND CREATED TWO GROUPS: THE BA GROUP (229 PATIENTS WITH 256 LIMBS) AND THE STENT GROUP (108 PATIENTS WITH 115 LIMBS). THE BA GROUP WAS TREATED WITH A NORMAL BALLOON (N = 250) AND SCORING BALLOON (N = 6). THE STENT GROUP WAS TREATED WITH THE S.M. A.R.T. STENT (CORDIS J&J, MIAMI, FL, N = 98), MISAGO (TERUMO, TOKYO, JAPAN, N = 3), AND ZILVER518 STENT (COOK, BLOOMINGTON, IN, N = 14).
FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 03-JUNE-2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1649282 | ZILVER 518 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Required Intervention |