BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 24136220 · Received January 21, 2026

    Report

    Report Number
    2024168-2026-00331
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    September 12, 2025
    Report Date
    January 21, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. FACTORS THAT CONTRIBUTE TO THE INABILITY TO RETRACT THE LEVER/FOOT, INCLUDE, BUT NOT LIMITED TO CALCIFICATION, TISSUE, OR SUTURE CAUGHT IN FOOT. THE INABILITY TO CLOSE THE FOOT LIKELY CONTRIBUTED TO THE DIFFICULTY TO REMOVE THE DEVICE. THE PATIENT EFFECTS ARE KNOWN POTENTIAL ADVERSE EVENTS OF USE OF THE DEVICE. IN THIS CASE, IT IS UNKNOWN IF THE REPORTED IFU DEVIATION CONTRIBUTED TO THE REPORTED DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. H6 MEDICAL DEVICE PROBLEM CODE- 2017 IMPROPER OR INCORRECT PROCEDURE OR METHOD- AGAINST RESISTANCE. MEDWATCH ATTACHED.

    Description of Event or Problem · 0

    MEDSUN REPORT WAS RECEIVED THAT STATES, "PATIENT CAME TO OPERATING ROOM FOR PROCEDURE OF ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR). DURING PROCEDURE, ATTENDING SURGEON ATTEMPTED TO USE ENDOVASCULAR CLOSURE DEVICES, PERCLOSES. SURGEON NEEDS X4 PERCLOSE TO COMPLETE CASE. X7 PERCLOSES WERE OPENED FOR CASE, 3 WASTED AS THEY DID NOT DEPLOY PROPERLY. PERCLOSE IS MADE BY ABBOTT MEDICAL, REFERENCE NUMBER 12773-03. THE LOT NUMBERS FOR THE MALFUNCTIONING DEVICES ARE 5080841, LOT NUMBER 5072641 EXPIRES 06/30/2027 X1, AND LOT #5081442 EXPIRES 07/31/2027 X 2. SURGEON WAS ABLE TO RECEIVE ADEQUATE RESULTS WITH PERCLOSE CLOSURE DEVICES X4 AFTER DISCARDING FAILED PERCLOSES." IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED LEFT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. REPORTEDLY, THE FOOTPLATE DID NOT RETRACT DESPITE TRYING TO REOPEN AND CLOSE THE FOOTPLATE. THE SAME ISSUE OCCURRED WITH THREE PROSTYLE DEVICES. THERE WAS RESISTANCE DURING REMOVAL OF THE THREE PROSTYLE DEVICES FROM THE ANATOMY AND ALL THREE DEVICES WERE REMOVED AGAINST RESISTANCE. THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO 16F AND THE EVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. THE PATIENT DEVELOPED A LARGE HEMATOMA. A SURGICAL CUT DOWN WAS PERFORMED TO TREAT THE HEMATOMA AND REPAIR THE LARGE TEAR, HEMOSTASIS WAS ACHIEVED VIA SURGICAL SUTURING. THE SUTURES OF TWO PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED AND USED TO ACHIEVE HEMOSTASIS AT THE RIGHT COMMON FEMORAL ARTERY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199982 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 5080841 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention