BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 12502367 · Received September 20, 2021

    Report

    Report Number
    2024168-2021-08344
    Event Type
    Death
    Date Received
    September 20, 2021
    Date of Event
    January 1, 2012
    Report Date
    November 8, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 AND H4: THE DEVICE EXPIRATION AND MANUFACTURING DATES COULD NOT BE PROVIDED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE PATIENT EFFECT OF DEATH IS LISTED IN THE ELECTRONIC PROGLIDE INSTRUCTIONS FOR USE (EIFU), AS POTENTIAL ADVERSE EVENTS OF USE OF THE DEVICE. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF DEATH, 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.

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ESTIMATED DATES. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECT AND OTHER DEVICE REPORTED IN THE ARTICLE ARE CAPTURED UNDER TWO SEPARATE MEDWATCH REPORTS. ATTACHED ARTICLE, TITLED: TRANSCATHETER AORTIC VALVE IMPLANTATION: ALL TRANSFEMORAL? UPDATE ON PERIPHERAL VASCULAR ACCESS AND CLOSURE.

    Description of Event or Problem · 1

    THIS LITERATURE REVIEW PRESENTED AN UPDATE OF RECENT DATA CONCERNING TRANSFEMORAL ACCESS AND PERCUTANEOUS CLOSURE DEVICES FOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). MULTIPLE VASCULAR CLOSURE DEVICES WERE DISCUSSED, INCLUDING THE PROGLIDE AND PROSTAR DEVICES. IT WAS REPORTED THAT PROGLIDE REMAINS ONE OF THE MOST WIDELY USED DEVICES AND DEMONSTRATES SUPERIOR EFFICACY AND SAFETY IN TERMS OF VASCULAR AND BLEEDING COMPLICATIONS. ALTHOUGH SOME COMPLICATIONS WERE NOTED WITH ALL VASCULAR CLOSURE DEVICES, ONE DATA POINT DISCUSSED A NON-ABBOTT DEVICE [MANTA] HAVING LOWER ALL-CAUSE MORTALITY AND BLEEDING EVENTS WHEN COMPARED TO THE PROGLIDE. ADDITIONAL DATA POINT ALSO IDENTIFIED NO DEVICE FAILURE WITH THE PROGLIDE BUT INCLUDED DEVICE FAILURE OCCURRENCE RATE OF 29.2% WITH THE PROSTAR XL. THE PROSTAR WAS ALSO LINKED TO BLEEDING. THE LITERATURE REVIEW CONCLUDED THAT DESPITE THE COMPLICATIONS, PERCUTANEOUS TRANSFEMORAL TAVI HAS SHOWN TECHNICAL IMPROVEMENT AND REMAINS THE STANDARD VASCULAR APPROACH. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED: TRANSCATHETER AORTIC VALVE IMPLANTATION: ALL TRANSFEMORAL? UPDATE ON PERIPHERAL VASCULAR ACCESS AND CLOSURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400439 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death