BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 10813648 · Received November 9, 2020

    Report

    Report Number
    2024168-2020-09340
    Event Type
    Death
    Date Received
    November 9, 2020
    Date of Event
    September 1, 2016
    Report Date
    November 9, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    PNY
    PMA / PMN Number
    P150023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH: ESTIMATED. DATE OF EVENT: ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT: ESTIMATED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORDS AND COMPLAINT HISTORIES COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBERS WERE NOT PROVIDED. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE OTHER PATIENT EVENTS NOTED IN THE ARTICLE ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE PATIENT DEATHS. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO THE FOLLOWING: CARDIAC DEATH, TARGET-VESSEL MYOCARDIAL INFARCTION, ISCHEMIA DRIVEN TARGET LESION RE-VASCULARIZATION, BLEEDING AND THROMBOSIS. DETAILS ARE LISTED IN THE ARTICLE, TITLED "ONE-YEAR RESULTS FOLLOWING A PRE-SPECIFIED ABSORB IMPLANTATION STRATEGY IN ST-ELEVATION MYOCARDIAL INFARCTION (BVS STEMI STRATEGY-IT STUDY)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275389 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE SCAFFOLD PNY ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death