BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 17044068 · Received June 1, 2023

    Report

    Report Number
    2024168-2023-05787
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    May 10, 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

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED A NEEDLE TO CUFF MISS WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. D4- LOT# WAS UPDATED FROM 3011041 TO 2102241. D4, H4: EXPIRATION AND MANUFACTURING DATES WERE CORRECTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH PROSTYLE DEVICES USING THE PRE-CLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) INTERVENTIONAL PROCEDURE. REPORTEDLY, PRE-PLACEMENT OF THE FIRST PROSTYLE DEVICE WAS SUCCESSFUL. WHEN ATTEMPTING TO PRE-PLACE THE SECOND PROSTYLE DEVICE, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED. THIS OCCURRED WITH A TOTAL OF NINE DEVICES IN SUCCESSION. THE USE OF THE PRE-CLOSE TECHNIQUE AND PROSTYLE DEVICES WERE ABANDONED. THE PROCEDURE WAS CONVERTED FROM PERCUTANEOUS TO OPEN SURGERY. HEMOSTASIS WAS ACHIEVED WITH SURGICAL INTERVENTION. A CLINICALLY SIGNIFICANT DELAY OCCURRED AS A RESULT OF SWITCHING TO OPEN SURGERY AND THE ANESTHESIA PERFORMED ON THE PATIENT WAS CHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323522 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2102241

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention PROSTYLE SUTURE