BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 17494590 · Received August 9, 2023

    Report

    Report Number
    2024168-2023-08604
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    June 29, 2023
    Report Date
    October 6, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED PLUNGER MECHANICAL JAM COULD NOT BE CONFIRMED AS THE PLUNGER WAS INSERTED AND THEN DEPRESSED IN THE DEVICE TO COMPLETELY DEPLOY THE NEEDLES WITH NO RESISTANCE NOTED. SUTURE RETRIEVAL ISSUE NEEDLE TO CUFF MISS AND LINK SEPARATION WAS OBSERVED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO CHALLENGING ANATOMICAL CONDITIONS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.D4, H3: LOT NUMBER UPDATED FROM 3011841 TO 2112441.

    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 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 FRIABLE AND UNHEALTHY RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROSTYLE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO AN INTERVENTIONAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. REPORTEDLY, ONE DEVICE WAS SUCCESSFULLY PRE-PLACED; HOWEVER, ON THE SECOND DEVICE, THE PLUNGER COULD NOT BE FULLY DEPRESSED. THE SUTURE OF A THIRD, NEW PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 14F AND THE TAVR PROCEDURE WAS COMPLETED. POST PROCEDURE, DUE TO THE CHALLENGING PATIENT ANATOMY, THE SUTURES DID NOT TAKE AND A CUTDOWN WAS PERFORMED. IT WAS FOUND THAT THE SUTURES DID NOT CAPTURE THE ARTERY AND ENDED UP IN THE SOFT TISSUE. HEMOSTASIS WAS ACHIEVED VIA MANUAL SUTURES DURING THE CUTDOWN. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684550 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2112441 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention VESSEL CLOSURE: PROSTYLE