ZILVER PACLITAXEL-ELUTING PERIPHERAL STENT
Report
- Report Number
- 3001845648-2023-00699
- Event Type
- Injury
- Date Received
- September 13, 2023
- Report Date
- March 6, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
POSSIBLE PMA/510(K) # P100022; P100022/S001; P100022/S014; P100022/S026; P100022/S027 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K)#: P100022/S027. THIS FILE WAS CREATED FROM PMCF STUDY TO CAPTURE 2 EVENTS OF LOSS OF PATENCY IN (B)(6). THIS FILE IS RELATED TO (B)(4). DEVICE EVALUATION: THE UNKNOWN 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. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL ZISV6 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE/LABEL: IT MAY BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0117) LISTS RESTENOSIS OF THE STENTED ARTERY AS A KNOWN POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/BASELINE CHARACTERISTICS. FROM THE INFORMATION PROVIDED, PATIENTS INCLUDED IN THE STUDY, HAD PERIPHERAL ARTERIAL DISEASE AND THEIR BASELINE CHARACTERISTICS INCLUDED HYPERTENSION, DIABETES AND SMOKING. THESE ARE ALL KNOWN PREDICTORS OF RESTENOSIS. RESTENOSIS OF THE STENTED ARTERY IS ALSO LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE IFU AND IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES THAT CAN BE CAUSED BY INJURY TO THE VESSEL (E.G. DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THAT LEADS TO OR AMPLIFIES THE RESTENOSIS PROCESS. IT MAY BE NOTED THAT THE SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG PACLITAXEL TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. AS PER MEDICAL ADVISOR INPUT "PRE-EXISTING CONDITIONS" WAS NOTED AS A POSSIBLE ROOT CAUSE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY: ACCORDING TO THE INITIAL REPORTER, THIS FILE WAS CREATED FROM A PMCF STUDY. THE XPEDITE STUDY IS A PRE-MARKET, INTERVENTIONAL, FEASIBILITY STUDY COMPARING THE CURRENTLY AVAILABLE ZILVER® PTX® DRUG-ELUTING PERIPHERAL STENT (TECHNICAL FILE: (B)(4) WITH TWO INVESTIGATIONAL PACLITAXEL DRUG COATINGS ON THE ZILVER® STENT. ALL 57 PATIENTS IN THE COMMERCIAL ZILVER PTX ARM HAD A SINGLE DE NOVO LESION; LESIONS WERE TREATED WITH A TOTAL OF 93 COMMERCIAL ZILVER PTX STENTS. STENT SIZING AND PLACEMENT WERE DETERMINED BY THE SITES DURING THE INDEX PROCEDURE. THIS FILE CAPTURES OF LOSS OF PATENCY IN (B)(6). CONFIRMED QUANTITY OF 2 DEVICES, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, PATIENT OUTCOME, AS PER INFORMATION PROVIDED SURGICAL INTERVENTION WAS REQUIRED. AS PER MEDICAL ADVISOR INPUT "REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4." INVESTIGATION FINDINGS CONCLUDE THAT A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/BASELINE CHARACTERISTICS. AS PREVIOUSLY NOTED, RESTENOSIS OF THE STENTED ARTERY AS A KNOWN POTENTIAL ADVERSE EVENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # P100022/S027. THIS FILE WAS CREATED FROM PMCF STUDY TO CAPTURE 2 EVENTS OF RESTENOSIS/OCCLUSION AND LOSS OF PATENCY IN NEW ZEALAND. THIS FILE IS RELATED TO (B)(4), (B)(4) AND (B)(4). DEVICE EVALUATION: THE UNKNOWN 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. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL ZISV6 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN INSTRUCTIONS FOR USE/LABEL: IT MAY BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0117) LISTS RESTENOSIS OF THE STENTED ARTERY AND OCCLUSION AS KNOWN POTENTIAL ADVERSE EVENTS. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/BASELINE CHARACTERISTICS. FROM THE INFORMATION PROVIDED, PATIENTS INCLUDED IN THE STUDY, HAD PERIPHERAL ARTERIAL DISEASE AND THEIR BASELINE CHARACTERISTICS INCLUDED HYPERTENSION, DIABETES AND SMOKING. THESE ARE ALL KNOWN PREDICTORS OF RESTENOSIS. RESTENOSIS OF THE STENTED ARTERY IS ALSO LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE IFU AND IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES THAT CAN BE CAUSED BY INJURY TO THE VESSEL (E.G. DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THAT LEADS TO OR AMPLIFIES THE RESTENOSIS PROCESS. IT MAY BE NOTED THAT THE SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG PACLITAXEL TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. OCCLUSION IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE IFU. DIABETES, HIGH BLOOD PRESSURE AND PERIPHERAL ARTERIAL DISEASE ARE ALL RISK FACTORS FOR DEVELOPING ARTERIAL OCCLUSION. AS PER MEDICAL ADVISOR INPUT "PRE-EXISTING CONDITIONS" WAS NOTED AS A POSSIBLE ROOT CAUSE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY: ACCORDING TO THE INITIAL REPORTER, THIS FILE WAS CREATED FROM A PMCF STUDY. THE XPEDITE STUDY IS A PRE-MARKET, INTERVENTIONAL, FEASIBILITY STUDY COMPARING THE CURRENTLY AVAILABLE ZILVER® PTX® DRUG-ELUTING PERIPHERAL STENT (TECHNICAL FILE: ITF054-CSEVS-DD) WITH TWO INVESTIGATIONAL PACLITAXEL DRUG COATINGS ON THE ZILVER® STENT. ALL 57 PATIENTS IN THE COMMERCIAL ZILVER PTX ARM HAD A SINGLE DE NOVO LESION; LESIONS WERE TREATED WITH A TOTAL OF 93 COMMERCIAL ZILVER PTX STENTS. STENT SIZING AND PLACEMENT WERE DETERMINED BY THE SITES DURING THE INDEX PROCEDURE. THIS FILE CAPTURES OF RESTENOSIS/OCCLUSION AND LOSS OF PATENCY IN NEW ZEALAND. CONFIRMED QUANTITY OF 2 DEVICES, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, PATIENT OUTCOME, AS PER INFORMATION PROVIDED SURGICAL INTERVENTION WAS REQUIRED. AS PER MEDICAL ADVISOR INPUT "REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4". INVESTIGATION FINDINGS CONCLUDE THAT A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/BASELINE CHARACTERISTICS. AS PREVIOUSLY NOTED, RESTENOSIS OF THE STENTED ARTERY AND OCCLUSION ARE KNOWN POTENTIAL ADVERSE EVENTS.
XPEDITE: PACLITAXEL-COATED PERIPHERAL STENTS USED IN THE TREATMENT OF FEMOROPOPLITEAL STENOSES STUDY NUMBER (B)(4). THE XPEDITE STUDY IS A PRE-MARKET, INTERVENTIONAL, FEASIBILITY STUDY COMPARING THE CURRENTLY AVAILABLE ZILVER® PTX® DRUG-ELUTING PERIPHERAL STENT (TECHNICAL FILE: ITF054-CSEVS-DD) WITH TWO INVESTIGATIONAL PACLITAXEL DRUG COATINGS ON THE ZILVER® STENT. ALL 57 PATIENTS IN THE COMMERCIAL ZILVER PTX ARM HAD A SINGLE DE NOVO LESION; LESIONS WERE TREATED WITH A TOTAL OF 93 COMMERCIAL ZILVER PTX STENTS. STENT SIZING AND PLACEMENT WERE DETERMINED BY THE SITES DURING THE INDEX PROCEDURE. ALL COMMERCIAL ZILVER PTX STENTS IN THE XPEDITE STUDY WERE IMPLANTED USING THE THUMBWHEEL DELIVERY SYSTEM. PRIMARY PATENCY WAS ASSESSED USING DUPLEX ULTRASOUND. THE 2 YEAR PRIMARY PATENCY RATE WAS 75.0% ± 5.9%, WITH A TOTAL OF 15 FAILURES IN THE COMMERCIAL ZILVER PTX ARM OF THE XPEDITE CLINICAL STUDY. THIS FILE WILL CAPTURE 2 EVENTS OF LOSS OF PATENCY IN NEW ZEALAND. RELATED TO PR403361 / MDR REF# (B)(4). PATIENT OUTCOME: SURGICAL INTERVENTION.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-FEB-2024.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. UPDATES TO ANNEX E CODE AND INVESTIGATION NOTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 861303 | ZILVER PACLITAXEL-ELUTING PERIPHERAL STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention |