BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG ELUTING PERIPHERAL STENT

    MDR report key: 9195790 · Received October 16, 2019

    Report

    Report Number
    3001845648-2019-00527
    Event Type
    Injury
    Date Received
    October 16, 2019
    Report Date
    October 16, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    USER FACILITY IS REFERENCED IN THE ARTICLE AS DEPARTMENT OF CARDIOLOGY, TOKAI UNIVERSITY SCHOOL OF MEDICINE, 143 SHIMOKASUYA, ISEHARA, KANAGAWA, JAPAN. DEVICE EVALUATION 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 RESTENOSIS OF THE STENTED ARTERY IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE INSTRUCTIONS FOR USE (IFU0117-4). THE IFU ALSO STATES ¿TO AVOID INVOLVEMENT OF THE COMMON FEMORAL ARTERY, THE PROXIMAL END OF THE STENT SHOULD BE PLACED AT LEAST 1 CM BELOW THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY.¿ THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE JAPANESE PACKAGING INSERT C-CI1502M02 SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO OFF-LABEL USE OF THE DEVICE AND/OR PATIENT PRE-EXISTING CONDITIONS. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE STENTS WERE IMPLANTED FROM THE CFA (COMMON FEMORAL ARTERY) TO THE SFA (SUPERFICIAL FEMORAL ARTERY). AS PER THE IFU THE USER IS ADVISED TO AVOID INVOLVEMENT OF THE CFA DURING STENT IMPLANTATION. IT IS ALSO KNOWN THAT THE PATIENT WAS ALREADY UNDERGOING ¿DUAL ANTI-PLATELET THERAPY¿. THE CONDITION FOR WHICH THE PATIENT WAS UNDERGOING THIS THERAPY IS UNKNOWN. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED ASPIRATION AND BALLOON ANGIOPLASTY AS A RESULT OF THIS EVENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    EVENT LOGGED FROM A REVIEW OF THE FOLLOWING ARTICLE: CARDIOVASCULAR INTERVENTION AND THERAPEUTICS (2019) 34:59¿61 HTTPS://DOI.ORG/10.1007/S12928-017-0501-X, VERY LATE DRUG-ELUTING STENT THROMBOSIS IN SUPERFICIAL FEMORAL ARTERY INVOLVING COMMON FEMORAL ARTERY, NORIHIKO SHINOZAKI1 · TSUTOMU MURAKAMI1 · YUJI IKARI1. THREE ZILVER PTX STENTS WERE IMPLANTED FROM BOTH COMMON FEMORAL ARTERIES (CFA) TO SFA WITH JAILED DFA. HE COMPLAINED OF ACUTE ONSET BILATERAL LEG REST PAIN AT 14 MONTHS AFTER DRUG-ELUTING STENT IMPLANTATION, EVEN THOUGH HE WAS UNDERGOING DUAL ANTI-PLATELET THERAPY (ASPIRIN 100 MG/DAY WITH CLOPIDOGREL 75 MG/DAY). BOTH ANKLE¿BRACHIAL INDEX (ABI) WAS UNMEASURABLE BECAUSE ANKLE PULSE WAVES WERE ALMOST FLAT. AN ANGIOGRAM SHOWED BILATERAL COMPLETE OCCLUSION EXTENDING FROM THE CFA TO THE DISTAL SFA. HE WAS UNABLE TO UNDERGO SURGICAL REPAIR DUE TO THE PRESENCE OF ACTIVE INTERSTITIAL PNEUMONIA. ASPIRATION AND BALLOON ANGIOPLASTY WITH 5.0 MM DIAMETER BALLOON VIA THE LEFT RADIAL ARTERY USING 4.5 FRENCH LONG GUIDING SHEATH LED TO ADEQUATE FLOW AND SYMPTOM RESOLUTION. ABI IMPROVED TO 0.68 ON THE RIGHT SIDE AND TO 0.84 ON THE LEFT SIDE, RESPECTIVELY. FDA MDR REPORTING REQUIRED: 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 THE PATIENT EXPERIENCED BILATERAL COMPLETE OCCULSION AND REQUIRED ASPIRATION AND BALLOON ANGIOPLASTY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. USER FACILITY IS REFERENCED IN THE ARTICLE AS DEPARTMENT OF CARDIOLOGY, (B)(4).

    Description of Event or Problem · 1

    EVENT LOGGED FROM A REVIEW OF THE FOLLOWING ARTICLE: CARDIOVASCULAR INTERVENTION AND THERAPEUTICS (2019) 34:59¿61. HTTPS://DOI.ORG/10.1007/S12928-017-0501-X, VERY LATE DRUG-ELUTING STENT THROMBOSIS IN SUPERFICIAL FEMORAL ARTERY. INVOLVING COMMON FEMORAL ARTERY, NORIHIKO SHINOZAKI1 · TSUTOMU MURAKAMI1 · YUJI IKARI1. THREE ZILVER PTX STENTS WERE IMPLANTED FROM BOTH COMMON FEMORAL ARTERIES (CFA) TO SFA WITH JAILED DFA. HE COMPLAINED OF ACUTE ONSET BILATERAL LEG REST PAIN AT 14 MONTHS AFTER DRUG-ELUTING STENT IMPLANTATION, EVEN THOUGH HE WAS UNDERGOING DUAL ANTI-PLATELET THERAPY (ASPIRIN 100 MG/DAY WITH CLOPIDOGREL 75 MG/DAY). BOTH ANKLE¿BRACHIAL INDEX (ABI) WAS UNMEASURABLE BECAUSE ANKLE PULSE WAVES WERE ALMOST FLAT. AN ANGIOGRAM SHOWED BILATERAL COMPLETE OCCLUSION EXTENDING FROM THE CFA TO THE DISTAL SFA. HE WAS UNABLE TO UNDERGO SURGICAL REPAIR DUE TO THE PRESENCE OF ACTIVE INTERSTITIAL PNEUMONIA. ASPIRATION AND BALLOON ANGIOPLASTY WITH 5.0 MM DIAMETER BALLOON VIA THE LEFT RADIAL ARTERY USING 4.5 FRENCH LONG GUIDING SHEATH LED TO ADEQUATE FLOW AND SYMPTOM RESOLUTION. ABI IMPROVED TO 0.68 ON THE RIGHT SIDE AND TO 0.84 ON THE LEFT SIDE, RESPECTIVELY. FDA MDR REPORTING REQUIRED: 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 THE PATIENT EXPERIENCED BILATERAL COMPLETE OCCULSION AND REQUIRED ASPIRATION AND BALLOON ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992052 ZILVER PTX DRUG ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention