BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 13416341 · Received February 1, 2022

    Report

    Report Number
    3001845648-2022-00048
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    March 19, 2015
    Report Date
    May 18, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE ZISV6 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZISV6 DEVICES ARE SUBJECT TO VISUAL 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 STENT MIGRATION AND STENT STRUT FRACTURE ARE KNOWN POTENTIAL ADVERSE EVENTS LISTED IN THE INSTRUCTIONS FOR USE (IFU0117). THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE VERY LONG LESION LENGTH WHICH WOULD BE AN INCREASED RISK FACTOR FOR STENT FRACTURE. SINCE THE FRACTURE WAS DETECTED DUE TO A SUDDEN PAIN, THIS MAY HAVE BEEN DUE TO A SUDDEN TORSIONAL STRESS THAT THE STENT COULD NOT WITHSTAND. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE. STENT FRACTURE AND STENT MIGRATION WAS OBSERVED IN THE IMAGE IN THE LITERATURE PAPER. THE PATIENT REQUIRED INTERVENTION/ADDITIONAL PROCEDURE TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

    Description of Event or Problem · 0

    OBERTO ET AL 2015 ¿ COMPARISON OF SFA LESION TREATMENT WITH ZILVER PTX IN DIABETICS VS. NON-DIABETICS: 2-YEAR CLINICAL AND FUNCTIONAL RESULTS.¿ BACKGROUND: PROSPECTIVE SINGLE-ARM STUDY, AIMED AT EVALUATING SAFETY AND EFFECTIVENESS AT 12 AND 24 MONTHS OF THE PACLITAXEL-ELUTING NITINOL STENT (ZILVER PTX), AND FOCUSED IN PARTICULAR ON THE TREATMENT OF COMPLEX LESIONS AND/OR DIABETIC PATIENTS. BETWEEN MAY 2010 AND MARCH 2012, 67 PATIENTS (78% MALES) WERE TREATED BY ZILVER PTX, BECAUSE OF STENOSIS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY IN ONE OF TWO CENTERS. STAGE RENAL DISEASE). ONE HUNDRED-TWO STENTS WERE USED (1.7±0.9 PER PATIENTS); MEDIAN 1 (RANGE 1-4). ALL PATIENTS HAD SUCCESSFUL STENT PLACEMENT. THE DES EVALUATED IN THE STUDY WAS THE ZILVER PTX NITINOL STENT (COOK MEDICAL, BLOOMINGTON, IN, USA), WHICH INCORPORATES A SELF-EXPANDING, FLEXIBLE NITINOL STENT PLATFORM WITH A 3 ¿G/MM2 POLYMER-FREE COATING OF PACLITAXEL ON ITS OUTER SURFACE. THIRTY-TWO OF 67 (48%) WERE DIABETICS, 14 (21%) ACTIVE SMOKERS AND 11 (14.6%) HAD CHRONIC RENAL FAILURE (END STAGE RENAL DISEASE). THE AVERAGE LENGTH OF LESIONS WAS 104±60 MM. OCCLUSION WAS COMPLETE IN 46.3% OF CASES, WHEREAS SEVERELY CALCIFIED LESIONS WERE PRESENT IN 30% OF PATIENTS (18.8% IN DIABETICS AND 31.4% IN NON-DIABETICS). TWENTY-SIX PATIENTS (39%) HAD TYPE C OR D LESIONS ACCORDING TO TASC 2. STENTS WERE PLACED AT LEAST 1 CM BELOW THE SFAORIGIN AND ABOVE THE MEDIAL FEMORAL EPICONDYLE TO FULLY COVER THE TARGET LESION(S). PRE-DILATATION AND POST DILATATION WERE AT THE PHYSICIAN¿S DISCRETION, WITH RESIDUAL STENOSIS <30% REQUIRED FOR PROCEDURAL SUCCESS. THE SAME ANTIPLATELET REGIMEN WAS RECOMMENDED FOR ALL PATIENTS. THIS COMPLAINT WAS OPENED TO CAPTURE STENT FRACTURE AND STENT MIGRATION- THERE WAS ONLY ONE PATIENT WHO HAD FRACTURE AND STENT MIGRATION (1.5%), DETERMINING SUDDEN PAIN OCCURRENCE BECAUSE OF VASCULAR OCCLUSION. AS PER FIGURE 5.¿ANGIOGRAM SHOWING POST-OPERATIVE STENT FRACTURE. THE PATIENT, A (B)(6), NON-DIABETIC MALE, HAD A 210-MM SFA OBSTRUCTION. THE LESION WAS TREATED WITH 3 PTX-COATED STENT (TWO 5×100 MM, AND ONE 6×100 MM). FOUR MONTHS AFTER ENDOVASCULAR SURGERY, THERE WAS A FRACTURE OF THE PROXIMAL 5×100-MM STENT, DETECTED BECAUSE OF SUDDEN PAIN AND VASCULAR OCCLUSION AND SHOWN IN THE ANGIOGRAM. REQUIRE INTERVENTION/ADDITIONAL PROCEDURES TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

    Description of Event or Problem · 0

    SUPPLEMENTAL MDR BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 18-MAY-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974156 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 76 YR Male Required Intervention