BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 9196318 · Received October 16, 2019

    Report

    Report Number
    3001845648-2019-00545
    Event Type
    Injury
    Date Received
    October 16, 2019
    Report Date
    November 13, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. - ATTACHMENT: [PHILLIPS - FULL DRUG-ELUTING STENT JACKET TWO-YEAR RESULTS OF A SINGLE-CENTER EXPERIENCE.PDF].

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THERE ARE 03 COMPLAINT FILES RELATING TO THIS LITERATURE ARTICLE. THIS FILE ((B)(4)) INVESTIGATES THE INTERVENTIONS PERFORMED AT 01 AND 02 YEARS FOR RESTENOSIS, (B)(4)INVESTIGATES RESTENOSIS AT 01 AND 02 YEARS AND (B)(4) INVESTIGATES OCCLUSION/RESTENOSIS REQUIRING SURGICAL BYPASS/REPAIR. 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 (IFU0118-5). 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 IT IS KNOWN THAT THE CLINICAL CHARACTERISTICS OF THE PATIENT GROUP INCLUDED DIABETES, CORONARY ARTERY DISEASE (CAD), DYSLIPIDEMIA, HYPERTENSION, PRIOR HEART ATTACK, PRIOR STROKE, FAMILY HISTORY OF VASCULAR DISEASE, CURRENT / FORMER SMOKER AND OBESITY. IT IS POSSIBLE THAT PATIENT PRE-EXISTING CONDITIONS CONTRIBUTED TO THE EVENT OF RESTENOSIS. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 32 PATIENTS REQUIRED RE-INTERVENTION (TARGET LESION REVASCULARISATION (TLR)) BETWEEN 01 AND 02 YEARS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    FOLLOW UP IS TO INFORM FDA INVESTIGATION IS STILL PENDING. AS REPORTED TO CUSTOMER RELATIONS: "THE FP TARGET LESIONS WERE CROSSED USING CONVENTIONAL WIRE AND CATHETER TECHNIQUES, FOLLOWED BY PREDILATION WITH A BALLOON ONE SIZE SMALLER THAN THE REFERENCE VESSEL DIAMETER TO ALLOW FOR STENT PLACEMENT. THE STENT(S) WERE POSTDILATED WITH BALLOONS SIZED IN A 1:1 RATIO WITH THE NORMAL VESSEL DIAMETER. THE NEED FOR TLR CONTINUED TO BE SIGNIFICANTLY LOWER IN THE SL COMPARED TO THE FDJ." "11/89 PATIENTS REQUIRED REINTERVENTION AFTER 1 YEAR AND 21/89 REQUIRED REINTERVENTION AFTER 2 YEARS."

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: "THE FP TARGET LESIONS WERE CROSSED USING CONVENTIONAL WIRE AND CATHETER TECHNIQUES, FOLLOWED BY PREDILATION WITH A BALLOON ONE SIZE SMALLER THAN THE REFERENCE VESSEL DIAMETER TO ALLOW FOR STENT PLACEMENT. THE STENT(S) WERE POSTDILATED WITH BALLOONS SIZED IN A 1:1 RATIO WITH THE NORMAL VESSEL DIAMETER. THE NEED FOR TLR CONTINUED TO BE SIGNIFICANTLY LOWER IN THE SL COMPARED TO THE FDJ." "11/89 PATIENTS REQUIRED REINTERVENTION AFTER 1 YEAR AND 21/89 REQUIRED REINTERVENTION AFTER 2 YEARS." FDA MDR REPORTING REQUIRED - SERIOUS INJURY REPORTING REQUIRED BASED ON THE REQUIREMENT OF "11/89 PATIENTS REQUIRED RE-INTERVENTION AFTER 1 YEAR AND 21/89 REQUIRED RE-INTERVENTION AFTER 2 YEARS"

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS: "THE FP TARGET LESIONS WERE CROSSED USING CONVENTIONAL WIRE AND CATHETER TECHNIQUES, FOLLOWED BY PREDILATION WITH A BALLOON ONE SIZE SMALLER THAN THE REFERENCE VESSEL DIAMETER TO ALLOW FOR STENT PLACEMENT. THE STENT(S) WERE POST DILATED WITH BALLOONS SIZED IN A 1:1 RATIO WITH THE NORMAL VESSEL DIAMETER. THE NEED FOR TLR CONTINUED TO BE SIGNIFICANTLY LOWER IN THE SL COMPARED TO THE FDJ." "11/89 PATIENTS REQUIRED REINTERVENTION AFTER 1 YEAR AND 21/89 REQUIRED REINTERVENTION AFTER 2 YEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992531 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