BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERA PLUS VASCULAR COVERED STENT SYSTEM

    MDR report key: 9941287 · Received April 8, 2020

    Report

    Report Number
    9681442-2020-00086
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Report Date
    July 22, 2020
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    00801741135873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRODUCT CLASSIFICATION CODE FOR THE COVERA PLUS VASCULAR STENT SYSTEM PRODUCT IS IDENTIFIED IN D2. H10: THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WILL BE PERFORMED. THE DEVICE FOR THIS MALFUNCTION HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER, A CD WITH X-RAYS WAS PROVIDED. THE INVESTIGATION IS INCONCLUSIVE FOR MIGRATION. A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AASME07060 VASCULAR COVERED STENT ALLEGEDLY EXPERIENCED MIGRATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF 53 YEAR OLD FEMALE IS 62 KGS.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER IDENTIFIED HAS NOT BEEN CLEARED IN THE US, BUT IS SIMILAR TO THE COVERA PLUS VASCULAR STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRODUCT CLASSIFICATION CODE FOR THE COVERA PLUS VASCULAR STENT SYSTEM PRODUCT IS IDENTIFIED. THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WILL BE PERFORMED. THE DEVICE FOR THIS MALFUNCTION HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER, CD WITH X-RAYS WAS PROVIDED. THE INVESTIGATION OF THE REPORTED MALFUNCTION IS CURRENTLY UNDERWAY. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AASME07060 VASCULAR COVERED STENT ALLEGEDLY EXPERIENCED MIGRATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF (B)(6) YEAR OLD FEMALE IS 62 KGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397677 COVERA PLUS VASCULAR COVERED STENT SYSTEM VASCULAR COVERED STENT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANDS0704 00801741135873

    Patients

    Seq Age Sex Outcome Treatment
    1