BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 16103497 · Received January 5, 2023

    Report

    Report Number
    2024168-2023-00163
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    December 15, 2022
    Report Date
    March 28, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED 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.B3; DATE OF EVENT. E1: LAST NAME SPELLING CORRECTION. D9, H3 - IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    STERILE DEVICES FROM THE SAME LOT (13, STERILE, UNUSED PERCLOSE PROSTYLE DEVICES PART# 12773-02 LOT# 2100442.) WERE RETURNED AND TESTED FOR OBSTRUCTION OF FLOW WITH NO ABNORMALITIES OBSERVED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS AND TESTING CONFIRMED THERE WAS NO OBSTRUCTION. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. STERILE DEVICES FROM THE SAME LOT (13, STERILE, UNUSED PERCLOSE PROSTYLE DEVICES PART# 12773-02 LOT# 2100442.) WERE RETURNED AND TESTED FOR OBSTRUCTION OF FLOW WITH NO ABNORMALITIES OBSERVED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, IT IS POSSIBLE, THE DEVICE WAS UNDER-INSERTED, OR AT THE INCORRECT ANGLE DUE TO THE ANATOMICAL CONDITIONS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D9, H3: DEVICE WAS RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROSTYLE DEVICE AFTER A MITRACLIP INTERVENTIONAL PROCEDURE. REPORTEDLY, NO BLOOD FLOW FROM THE MARKER LUMEN OCCURRED. A NEW PROSTYLE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENTLY TO THE INITIALLY FILED REPORTS, ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THE PRE-CLOSE TECHNIQUE WAS BEING USED WITH A 14F SHEATH. FOLLOWING THE MARKER LUMEN BLEED BACK ISSUE, THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE USE OF A 14F SHEATH WAS CONTINUED AND THE MITRACLIP PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192152 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2100442

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention MITRACLIP