BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVERA PLUS VASCULAR COVERED STENT

    MDR report key: 19582788 · Received June 21, 2024

    Report

    Report Number
    9681442-2024-00158
    Event Type
    Death
    Date Received
    June 21, 2024
    Date of Event
    December 19, 2019
    Report Date
    June 17, 2024
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    00801741135910
    PMA / PMN Number
    P170042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE COVERA PLUS VASCULAR COVERED STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE COVERA PLUS VASCULAR COVERED STENT SYSTEM PRODUCTS ARE IDENTIFIED IN D2 AND G4. H10: MANUFACTURING REVIEW: THE LOT HISTORY RECORDS OF THIS LOT WERE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. BASED ON THE INFORMATION AVAILABLE IT IS NOT REASONABLY SUGGESTED THAT A MANUFACTURING PROCESS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND NO X-RAY IMAGES WERE PROVIDED FOR REVIEW. IT WAS REPORTED THAT THE PATIENT EXPIRED, AND A CAUSE OF DEATH WAS NOT PROVIDED. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION IS CLOSED WITH INCONCLUSIVE RESULT. NO DEVICE DEFICIENCY AND NO RELATIONSHIP OF THE CLINICAL EVENT TO THE DEVICE OR THE PROCEDURE WAS REPORTED. LABELING REVIEW: THE RELEVANT LABELING APPLICABLE FOR THIS PRODUCT WAS REVIEWED. BASED ON THE INSTRUCTIONS FOR USE SUPPLIED WITH THIS PRODUCT THE COVERA PLUS VASCULAR COVERED STENT IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC LESIONS IN THE COMMON AND EXTERNAL ILIAC ARTERY. POTENTIAL COMPLICATIONS AND ADVERSE EVENTS WHICH MAY OCCUR WERE FOUND ADDRESSED, E.G., COVERED STENT STENOSIS/THROMBOTIC OCCLUSION, EMBOLISM, STENOSIS/THROMBOTIC OCCLUSION OUTSIDE OF STENTED SEGMENT. PREPARATION, DELIVERY SYSTEM INTRODUCTION AND COVERED STENT DEPLOYMENT WERE FOUND TO BE DESCRIBED IN DETAIL. H10: D4 (EXPIRATION DATE: 08/2021). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT SOMETIME POST A VASCULAR COVERED STRAIGHT STENT GRAFT PLACEMENT IN THE LEFT LEG COMMON ILIAC ARTERY, THE SUBJECT HAD AN ADVERSE EVENT OF FALSE ANEURYSM IN THE LEFT LEG SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE ADVERSE EVENT WAS SUCCESSFULLY TREATED WITH THROMBUS REJECTION AND COMPRESSION DRESSING. IT WAS FURTHER REPORTED THAT FOUR YEARS, FIVE MONTHS, AND FOUR DAYS POST A VASCULAR COVERED STRAIGHT STENT GRAFT PLACEMENT, THE SUBJECT WAS EXPIRED. THE CAUSE OF DEATH AND THE RELATIONSHIP TO THE DEVICE, PROCEDURE AND ARTERIOVENOUS ACCESS CIRCUIT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115944 COVERA PLUS VASCULAR COVERED STENT VASCULAR COVERED STENT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANDV1842 00801741135910

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death CLOPIDOGREL.