ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2022-00479
- Event Type
- Injury
- Date Received
- July 27, 2022
- Date of Event
- November 26, 2020
- Report Date
- February 8, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. 510K P050017/S006.
PMA/510(K) #P050017/S006. 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. THIS FILE IS RELATED TO (B)(4) / MDR #3001845648-2022-00478 AND IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE REF. ATT. ¿YISHENG LIN 2021.PDF¿. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER FLEX 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. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE IS IFU0058. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. FROM THE ARTICLE IT IS KNOWN THAT THE STUDY INCLUDED ONLY PATIENTS WITH TASC C AND D LESIONS. RISK FACTORS FOR THROMBOSIS INCLUDED LONG HISTORY OF SMOKING, ARTERIAL HYPERTENSION, DIABETES MELLITUS, CORONARY ARTERY DISEASE AND CHRONIC RENAL FAILURE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER YISHENG LIN ET AL ¿MID-TERM OUTCOMES OF ENDOVASCULAR TREATMENT AND RISK FACTORS FOR RECURRENCE IN PATIENTS WITH TRANS-ATLANTIC-INTER-SOCIETY II C/D FEMOROPOPLITEAL LESIONS¿. ACCORDING TO THE INITIAL REPORTER, 02 PATIENTS UNDERWENT RECANALIZATION FOLLOWING THROMBOSIS. AS PER MEDICAL ADVISOR INPUT ¿REQUIRE INTERVENTION/ADDITIONAL PROCEDURES TO PREVENT PERMANENT IMPAIRMENT/DAMAGE¿ . COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE PATIENTS IN THIS STUDY RECEIVED SELF-EXPANDING STENTS, OF WHICH 64 WERE BARE METAL STENTS (LIFESTENT FLEXSTAR; BARD PERIPHERAL VASCULAR INC., TEMPE, AZ, USA; ZILVER FLEX, COOK MEDICAL, BLOOMINGTON, IN, USA) WITH SOME STENT GRAFTS (VIABAHN; GORE MEDICAL, FLAGSTAFF, AZ, USA). ONCE THE GUIDEWIRE CATHETER HAD PASSED THROUGH THE TRUE VASCULAR CAVITY, A PERCUTANEOUS DIRECTIONAL ATHERECTOMY WAS PERFORMED (SEE FIGURE 5). A PERIPHERAL PLAQUE EXCISION SYSTEM (SILVERHAWK OR TURBOHAWK) WAS USED TO CUT THROUGH THE ENTIRE LESION ALONG THE PRECEDING 0.035 CM GUIDE WIRE, WHICH WAS PASSED THROUGH THE OCCLUDED SEGMENT INTO THE DISTAL OUTFLOW TRACT USING THE EXCHANGE TECHNIQUE. GUIDED BY THE ROADMAP, THE CUTTING EDGE WAS AIMED AT THE SCLEROSIS PLAQUE AND PUSHED TO EXCISE THE PLAQUE SLOWLY AND UNIFORMLY. ACUTE THROMBOSIS WAS OBSERVED IN 2 CASES (SEE FIGURE 10). ONE OF THESE CASES WAS RECANALIZED AFTER THROMBOLYSIS, AND THE OTHER WAS RECANALIZED AFTER COMBINED THROMBOLYSIS AND BALLOON EXPANSION **FILE CREATED FOR POTENTIAL OF THIS OCCURRING WITH ZILVER STENT**.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 8-FEB-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1943583 | ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |