BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 10087921 · Received May 26, 2020

    Report

    Report Number
    2024168-2020-04492
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    November 1, 2015
    Report Date
    July 30, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    PNY
    PMA / PMN Number
    P150023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    C4: THERAPY DATE ESTIMATED. THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [ARTICLE CN-032113.PDF].

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT AND IMPLANT IS ESTIMATED TO BE (B)(6) 2015. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE PATIENT DEATHS REFERENCED ARE BEING FILED ON A SEPARATE MEDWATCH REPORT #. LITERATURE. ¿ARTICLE TITLE- PREDICTORS OF LONG-TERM ADVERSE EVENTS AFTER ABSORB BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION: A 1,933-PATIENT POOLED ANALYSIS FROM INTERNATIONAL REGISTRIES".

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD THAT MAY BE RELATED TO DEATH AND SERIOUS INJURY. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED, PREDICTORS OF LONG-TERM ADVERSE EVENTS AFTER ABSORB BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION: A 1,933-PATIENT POOLED ANALYSIS FROM INTERNATIONAL REGISTRIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549725 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE SCAFFOLD PNY ABBOTT VASCULAR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R| S