ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Report
- Report Number
- 3001845648-2019-00536
- Event Type
- Injury
- Date Received
- October 16, 2019
- Date of Event
- September 22, 2018
- Report Date
- February 11, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- PMA / PMN Number
- P100022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THERE ARE 7 US SITES REFERENCED IN THE ATTACHED PUBLISHED LITERATURE. AS PATIENT LEVEL DATA IS NOT REPORTED IN THE ARTICLE IT IS UNKNOWN HOW MANY PATIENTS AT WHICH SITE ARE AFFECTED BY THE REPORTED ADVERSE EVENTS. LANKENAU HEART INSTITUTE, WYNNEWOOD, PA, USA (W A GRAY MD) NEW YORK UNIVERSITY MEDICAL CENTER, NEW YORK, NY, USA (A BABAEV MD); AULTMAN HOSPITAL, NORTH CANTON, OH, USA (J T PREM MD); BETH ISRAEL DEACONESS MEDICAL CENTER, BOSTON, MA, USA (J POPMA MD); VASCORE, MASSACHUSETTS GENERAL HOSPITAL, BOSTON, MA, USA (M R JAFF DO); HARVARD MEDICAL SCHOOL, BOSTON, MA, USA (M R JAFF); BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA (J DIAZ-CARTELLE MD); - ATTACHMENT: [2018 - GRAY_-_A_POLYMER-COATED_PACLITAXEL-ELUTING_-ELUVIA-_VERSUS_A_POLYMER-FREE.PDF].
INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THERE ARE 7 US SITES REFERENCED IN THE ATTACHED PUBLISHED LITERATURE. AS PATIENT LEVEL DATA IS NOT REPORTED IN THE ARTICLE IT IS UNKNOWN HOW MANY PATIENTS AT WHICH SITE ARE AFFECTED BY THE REPORTED ADVERSE EVENTS. (B)(6).
THERE ARE 7 US SITES REFERENCED IN THE ATTACHED PUBLISHED LITERATURE. AS PATIENT LEVEL DATA IS NOT REPORTED IN THE ARTICLE IT IS UNKNOWN HOW MANY PATIENTS AT WHICH SITE ARE AFFECTED BY THE REPORTED ADVERSE EVENTS. LANKENAU HEART INSTITUTE, WYNNEWOOD, PA, USA (W A GRAY MD); NEW YORK UNIVERSITY MEDICAL CENTER, NEW YORK, NY, USA (A BABAEV MD); AULTMAN HOSPITAL, NORTH CANTON, OH, USA (J T PREM MD); BETH ISRAEL DEACONESS MEDICAL CENTER, BOSTON, MA, USA (J POPMA MD); VASCORE, MASSACHUSETTS GENERAL HOSPITAL, BOSTON, MA, USA (M R JAFF DO); HARVARD MEDICAL SCHOOL, BOSTON, MA, USA (M R JAFF); BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA (J DIAZ-CARTELLE MD); DEVICE EVALUATION: THIS FILE IS RELATED TO A NUMBER OF COMPLAINT FILES. EACH FILE RESULTED FROM THE ATTACHED LITERATURE ARTICLE (REF. ATT. ¿(B)(4) ET AL LITERATURE¿). MULTIPLE COMPLAINT FILES WERE OPENED TO CAPTURE EACH EVENT FOR EACH REGION MENTIONED AS IT WAS UNCLEAR FROM THE ARTICLE WHICH EVENT OCCURRED IN WHICH REGION. THE LITERATURE ARTICLE RELATING TO THIS FILE DID NOT SPECIFY WHAT THE SPECIFIC ADVERSE EVENT(S) WERE IN THIS CASE AND AS A RESULT THERE IS INSUFFICIENT INFORMATION AVAILABLE TO ASSIGN A FAILURE MODE AND EFFECT. AS A RESULT, A RISK ASSESSMENT CANNOT BE COMPLETED. IF MORE INFORMATION IS MADE AVAILABLE TO CIRL REGARDING THE NATURE OF THE ADVERSE EVENT(S) THE FILE WILL BE UPDATED ACCORDINGLY. THE ZILVER 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. DOCUMENT 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 PTX 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 THERE ARE SEVERAL KNOWN POTENTIAL ADVERSE EVENTS LISTED WITHIN THE INSTRUCTIONS FOR USE (IFU0118-5). THESE INCLUDE ISCHEMIA REQUIRING INTERVENTION (BYPASS OR AMPUTATION OF TOE, FOOT OR LEG), ATHEROEMBOLIZATION (BLUE TOE SYNDROME), HEMATOMA/HEMORRHAGE AND HISTOLOGICAL CHANGES IN VESSEL WALL, INCLUDING INFLAMMATION, CELLULAR DAMAGE OR NECROSIS. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. 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 CONDITIONS. FROM THE INFORMATION PROVIDED WITHIN THE LITERATURE ARTICLE IT IS KNOWN THAT THE STUDY ENROLLED ¿PATIENTS WITH SYMPTOMATIC LOWER-LIMB ISCHEMIA WHICH MANIFESTED AS CLAUDICATION (RUTHERFORD CATEGORY 2, 3 OR 4) WITH ATHEROSCLEROTIC LESIONS IN THE NATIVE SUPERFICIAL FEMORAL ARTERY OR PROXIMAL POPLITEAL ARTERY.¿ PATIENT PRE-EXISTING CONDITIONS INCLUDED SMOKING TYPE I DIABETES AND TYPE II DIABETES, HYPERLIPIDAEMIA, HYPERTENSION, CORONARY ARTERY DISEASE (CAD), MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE AND RENAL INSUFFICIENCY. IT IS POSSIBLE THAT THE ADVERSE EVENT(S) RESULTED FROM DETERIORATION IN PATIENT CONDITION. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT IS UNKNOWN IF ANY INTERVENTION WAS PERFORMED IN THIS CASE. THE EFFECTS TO THE PATIENT (IF ANY) ARE ALSO UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THERE ARE 7 US SITES REFERENCED IN THE ATTACHED PUBLISHED LITERATURE. AS PATIENT LEVEL DATA IS NOT REPORTED IN THE ARTICLE IT IS UNKNOWN HOW MANY PATIENTS AT WHICH SITE ARE AFFECTED BY THE REPORTED ADVERSE EVENTS. (B)(4).
STUDY: WILLIAM A GRAY A POLYMER-COATED, PACLITAXEL-ELUTING STENT (ELUVIA) VERSUS A POLYMER-FREE, PACLITAXEL-COATED STENT (ZILVER PTX) FOR ENDOVASCULAR FEMOROPOPLITEAL INTERVENTION (IMPERIAL): A RANDOMISED, NON-INFERIORITY TRIAL. "DEVICE-RELATED ADVERSE EVENTS IN 22 (14%) PATIENTS IN THE ZILVER PTX GROUP."
STUDY: WILLIAM A GRAY A POLYMER-COATED, PACLITAXEL-ELUTING STENT (ELUVIA) VERSUS A POLYMER-FREE, PACLITAXEL-COATED STENT (ZILVER PTX) FOR ENDOVASCULAR FEMOROPOPLITEAL INTERVENTION (IMPERIAL): A RANDOMISED, NON-INFERIORITY TRIAL. "DEVICE-RELATED ADVERSE EVENTS IN 22 (14%) PATIENTS IN THE ZILVER PTX GROUP." "THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS PATIENTS EXPERIENCED UNKNOWN DEVICE RELATED ADVERSE EVENTS AND UNDER THE ASSUMPTION THAT INTERVENTION WAS REQUIRED."
STUDY: A POLYMER-COATED, PACLITAXEL-ELUTING STENT (ELUVIA) VERSUS A POLYMER-FREE, PACLITAXEL-COATED STENT (ZILVER PTX) FOR ENDOVASCULAR FEMOROPOPLITEAL INTERVENTION (IMPERIAL): A RANDOMISED, NON-INFERIORITY TRIAL. "DEVICE-RELATED ADVERSE EVENTS IN 22 (14%) PATIENTS IN THE ZILVER PTX GROUP."
STUDY: (B)(6) A POLYMER-COATED, PACLITAXEL-ELUTING STENT (ELUVIA) VERSUS A POLYMER-FREE, PACLITAXEL-COATED STENT (ZILVER PTX) FOR ENDOVASCULAR FEMOROPOPLITEAL INTERVENTION (IMPERIAL): A RANDOMISED, NON-INFERIORITY TRIAL. "DEVICE-RELATED ADVERSE EVENTS IN 22 (14%) PATIENTS IN THE ZILVER PTX GROUP."
INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THERE ARE 7 US SITES REFERENCED IN THE PUBLISHED LITERATURE. AS PATIENT LEVEL DATA IS NOT REPORTED IN THE ARTICLE IT IS UNKNOWN HOW MANY PATIENTS AT WHICH SITE ARE AFFECTED BY THE REPORTED ADVERSE EVENTS. LANKENAU HEART INSTITUTE, WYNNEWOOD, PA, USA (W A GRAY MD); NEW YORK: UNIVERSITY MEDICAL CENTER, NEW YORK, NY, USA (A BABAEV MD); AULTMAN: HOSPITAL, NORTH CANTON, OH, USA (J T PREM MD); BETH ISRAEL: DEACONESS MEDICAL CENTER, BOSTON, MA, USA (J POPMA MD); VASCORE, MASSACHUSETTS; GENERAL HOSPITAL, BOSTON, MA, USA (M R JAFF DO); HARVARD MEDICAL SCHOOL, BOSTON, MA, USA (M R JAFF); BOSTON: SCIENTIFIC, MARLBOROUGH, MA, USA (J DIAZ-CARTELLE MD).
STUDY: WILLIAM A GRAY, A POLYMER-COATED, PACLITAXEL-ELUTING STENT (ELUVIA) VERSUS A POLYMER-FREE, PACLITAXEL-COATED STENT (ZILVER PTX) FOR ENDOVASCULAR FEMOROPOPLITEAL INTERVENTION (IMPERIAL): A RANDOMISED, NON-INFERIORITY TRIAL. "DEVICE-RELATED ADVERSE EVENTS IN 22 (14%) PATIENTS IN THE ZILVER PTX GROUP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 994408 | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |