BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 10820050 · Received November 10, 2020

    Report

    Report Number
    2024168-2020-09397
    Event Type
    Death
    Date Received
    November 10, 2020
    Date of Event
    September 3, 2016
    Report Date
    November 10, 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. DATE OF IMPLANT - ESTIMATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED 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. ARTICLE TITLE ¿ONE-YEAR RESULTS FOLLOWING A PRE-SPECIFIED ABSORB IMPLANTATION STRATEGY IN ST-ELEVATION MYOCARDIAL INFARCTION (BVS STEMI STRATEGY IT STUDY)". THE OTHER PATIENT EVENTS NOTED IN THE ARTICLE ARE FILED UNDER SEPARATE MFR REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO THE FOLLOWING: AFTER PRE-DILATATION OF THE LESION IN THE LEFT ANTERIOR DESCENDING TO DIAGONAL CORONARY ARTERY, A 3.0X28MM ABSORB SCAFFOLD WAS IMPLANTED AND POST DILATED. TWO DAYS POST-PROCEDURE, THE PATIENT DIED (SUDDEN CARDIAC DEATH) FROM PROBABLE SCAFFOLD THROMBOSIS. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "ONE-YEAR RESULTS FOLLOWING A PRE-SPECIFIED ABSORB IMPLANTATION STRATEGY IN ST-ELEVATION MYOCARDIAL INFARCTION (BVS STEMI STRATEGY-IT STUDY)". PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION. SPECIFICALLY, THIS EVENT CAPTURES CASE 1 FROM TABLE 3 IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281134 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE SCAFFOLD PNY ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death