BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 10005730 · Received April 28, 2020

    Report

    Report Number
    2024168-2020-03949
    Event Type
    Injury
    Date Received
    April 28, 2020
    Date of Event
    December 1, 2013
    Report Date
    July 28, 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. ATTACHMENT: [E-24379 ARTICLE CN-030368.PDF].

    Additional Manufacturer Narrative · 1

    EVENT DATES ESTIMATED. THE ADDITIONAL PATIENT DEATH REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL DEVICE MALFUNCTIONS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL UNK XIENCE REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, DISSECTION, AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF CORONARY SCAFFOLDS. 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 MANUFACTURE, DESIGN OR LABELING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, CARDIAC ARREST, REVASCULARIZATION, REHOSPITALIZATION, MALPOSITION, AND STENTS JAILING OR OCCLUDING VESSELS. ADDITIONALLY, IT WAS ALSO IDENTIFIED THAT ABSORB MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, DISSECTION, REVASCULARIZATION, REHOSPITALIZATION, AND MALPOSITION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE AND ABSORB STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE 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
    470471 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE SCAFFOLD PNY ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S