ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2018-00453
- Event Type
- Injury
- Date Received
- September 27, 2018
- Report Date
- September 27, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
510 (K) NUMBER: N/A. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510 (K) NUMBER: NP100022/S014. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. DEVICE EVALUATION: THE ZISV6-35-125-6-120-PTX DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. IT WAS CONFIRMED THAT THE COMPLAINT STENT WAS PLACED IN THE SUPERFICIAL FEMORAL ARTERY WHICH HAD CALCIUM PRESENT AT THE TIME. IT IS UNKNOWN WHETHER OR NOT THE PATIENT HAD ANY PRE-EXISTING CONDITIONS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. NO IMAGING HAS BEEN PROVIDED FOR EVALUATION AT THIS TIME. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. AS THE DEVICE AND IMAGES WERE NOT AVAILABLE FOR EVALUATION AND AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT MAY BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0118-3) LISTS STENT STRUT FRACTURE AS A KNOWN POTENTIAL ADVERSE EVENT. DOCUMENT REVIEW: AS THE LOT NUMBER OF THE COMPLAINT STENTS IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY AS PER FINISHED PRODUCT Q.C. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE RISK WAS DETERMINED TO BE MODERATE (CATEGORY II). ACCORDING TO THE INITIAL REPORTER, THE FRACTURED STENT WAS BALLOONED WITH A DRUG COATED BALLOON (UNKNOWN MANUFACTURER). COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
AS REPORTED TO CUSTOMER RELATIONS: THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2017 IN WHICH THE ZILVER PTX 35 DRUG-ELUTING STENT, G38482, WAS INITIALLY IMPLANTED IN THE PATIENTS LEG (NOT CONFIRMED WHICH LEG). DURING THE WEEK OF (B)(6) 2018 THE PATIENT WAS UNDERGOING ANOTHER INTERVENTION PROCEDURE ON THE OPPOSITE LEG. THE PHYSICIAN ALWAYS TAKES AN IMAGE OF THE PREVIOUS LEG AS A CHECK TO ENSURE ALL IS STILL AS INTENDED. THIS IS WHEN IT WAS NOTED THAT THE STENT WAS FRACTURED WHICH DUE TO THIS THE PHYSICIAN DID A PROCEDURE. PHYSICIAN PUT A DRUG COATED BALLOON, UNKNOWN MANUFACTURE, BALLOON BETWEEN THE FRACTURED STENT AND BALLOONED IT. DISTRICT MANAGER HAD NO FURTHER INFORMATION PROVIDED TO HIM.
AS REPORTED TO CUSTOMER RELATIONS: THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2017 IN WHICH THE ZILVER PTX 35 DRUG-ELUTING STENT, G38482, WAS INITIALLY IMPLANTED IN THE PATIENTS LEG (NOT CONFIRMED WHICH LEG). DURING THE WEEK OF (B)(6) 2018 THE PATIENT WAS UNDERGOING ANOTHER INTERVENTION PROCEDURE ON THE OPPOSITE LEG. THE PHYSICIAN ALWAYS TAKES AN IMAGE OF THE PREVIOUS LEG AS A CHECK TO ENSURE ALL IS STILL AS INTENDED. THIS IS WHEN IT WAS NOTED THAT THE STENT WAS FRACTURED WHICH DUE TO THIS THE PHYSICIAN DID A PROCEDURE. PHYSICIAN PUT A DRUG COATED BALLOON, UNKNOWN MANUFACTURE, BALLOON BETWEEN THE FRACTURED STENT AND BALLOONED IT. DISTRICT MANAGER HAD NO FURTHER INFORMATION PROVIDED TO HIM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 757874 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |