BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORB

    MDR report key: 9996137 · Received April 24, 2020

    Report

    Report Number
    2024168-2020-03878
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    March 5, 2016
    Report Date
    July 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    PNY
    PMA / PMN Number
    P150023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA ATTACHMENT: [ARTICLE CN-030772.PDF].

    Additional Manufacturer Narrative · 1

    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 UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE CIRCUMFLEX AND OBTUSE MARGINAL CORONARY ARTERY. THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.5X15MM BALLOON AT 20 ATMOSPHERES (ATMS), AND THE 2.5X12MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED AT 16 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.75X15MM BALLOON AT 18 ATMS. THE PATIENT DEVELOPED THROMBOSIS AND A MI 825 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458489 ABSORB BIORESORBABLE SCAFFOLD PNY ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S