BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 13425601 · Received February 2, 2022

    Report

    Report Number
    2024168-2022-01128
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    January 13, 2022
    Report Date
    March 2, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 TWO ADDITIONAL PROSTYLE DEVICES WITH REPORTED ISSUES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    NAG3: INITIAL G3 DATE FOR MEDWATCH# 2024168-2022-01128-00 CORRECTED FROM 01/14/2022 TO 01/13/2022.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 DIFFICULTY 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 THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.NA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BILATERAL SUTURE PLACEMENT IN THE RIGHT AND LEFT COMMON FEMORAL ARTERIES (RCFA AND LCFA) WAS ATTEMPTED WITH THREE PROSTYLE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO AN AORTIC PROSTHESIS INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED WITH ONE PROSTYLE DEVICE IN THE LEFT COMMON FEMORAL ARTERY, AND WITH TWO PROSTYLE DEVICES IN THE RIGHT COMMON FEMORAL ARTERY. THE SUTURES OF TWO PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED IN EACH ACCESS SITE. THE SHEATH WAS UPSIZED TO 12F IN THE LCFA AND 18F IN THE RCFA. HEMOSTASIS WAS ACHIEVED IN BOTH ACCESS SITES WITH THE SUCCESSFULLY 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
    327364 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 1091541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention HEPARIN