BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 23660910 · Received November 26, 2025

    Report

    Report Number
    2024168-2025-11769
    Event Type
    Death
    Date Received
    November 26, 2025
    Date of Event
    January 1, 2017
    Report Date
    November 26, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. THE PATIENT EFFECTS OF DEATH IS LISTED IN THE ELECTRONIC PERCLOSE PROGLIDE INSTRUCTIONS FOR USE (IFU), AS POTENTIAL ADVERSE EVENTS OF USE OF THE DEVICE. BASED ON THE ARTICLE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, 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. B2, B3: DATES ESTIMATED. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. ARTICLE TITLED: SINGLE PERCLOSE ESCALATION TECHNIQUE: A NOVEL APPROACH FOR VASCULAR CLOSURE FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT.

    Description of Event or Problem · 0

    THE STUDY AS AIMED TO EVALUATE THE SAFETY AND EFFICACY OF THE SINGLE PERCLOSE PROGLIDE ESCALATION TECHNIQUE (SPET) AND COMPARE IT WITH DOUBLE PERCLOSE PROGLIDE TECHNIQUE (DPT). PATIENTS UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) USING THE PRE-CLOSE TECHNIQUE FOR A LARGE-BORE ARTERIAL ACCESS. COMPLICATIONS LISTED: PSEUDOANEURYSM, FEMORAL BLEEDING, FEMORAL OCCLUSION, LONGER HOSPITAL STAYS, DEATH (30-DAYS). BAIL-OUTS LISTED: MANUAL COMPRESSION, ADDITIONAL DEVICE, STENT/BALLOON ANGIOPLASTY, SURGICAL REPAIR. IT WAS CONCLUDED THAT THE SPET TECHNIQUE APPEARS TO BE SAFE AND EFFECTIVE AFTER TRANSFEMORAL TAVR, REDUCING MINOR VASCULAR COMPLICATIONS WITHOUT INCREASING THE RISK OF MAJOR VASCULAR COMPLICATIONS OR BLEEDING COMPARED TO DPT. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED "SINGLE PERCLOSE ESCALATION TECHNIQUE: A NOVEL APPROACH FOR VASCULAR CLOSURE FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899355 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death