BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 16856347 · Received May 2, 2023

    Report

    Report Number
    2024168-2023-04609
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 13, 2023
    Report Date
    July 13, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE OTHER PERCLOSE PROSTYLE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    ANALYSIS AND SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. ADDITIONALLY, RETURNED DEVICE ANALYSIS DEEMED THE POSTERIOR CUFF TABS WERE NOT BENT AS EXPECTED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE REPORTED NEEDLE TO CUFF MISS WAS CONCLUDED TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE DUE TO THE POSTERIOR CUFF TABS NOT BEING BENT AS EXPECTED. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. THE SUBSEQUENT TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE.D4; LOT NUMBER CHANGED FROM 2121441 TO 3010942.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH FOUR PROSTYLE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) INTERVENTIONAL PROCEDURE. REPORTEDLY, WITH ALL 4 DEVICES, WHEN THE PLUNGER WAS PULLED BACK IN STEP 3, THE SUTURE WAS NOT PRESENT. THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 14F AND THE TAVI PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND 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
    160827 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3010942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention