BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 17999008 · Received October 24, 2023

    Report

    Report Number
    2024168-2023-11795
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    October 3, 2023
    Report Date
    January 17, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY DEPLOYING THE FOOT RELATED TO THE LINK COULD NOT BE CONFIRMED AS THE FOOT DEPLOYMENT AND RETRACTION FUNCTIONED AS EXPECTED BASED ON RETURNED DEVICE ANALYSIS. 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 IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED BASED ON THE RETURNED DEVICE ANALYSIS. FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY DEPLOYING THE FOOT MAY INCLUDE, BUT ARE NOT LIMITED TO, INTERACTION WITH PATIENT TISSUE. BASED ON THE RETURNED DEVICE ANALYSIS, THE FOOT DEPLOYED AS EXPECTED; HOWEVER, IT IS UNKNOWN IF THE LINK TRULY CONTRIBUTED TO THE REPORTED DIFFICULTY DEPLOYING THE FOOT. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.D4- LOT # UPDATED FROM UNK TO 3060942

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    THIS WAS REPORTED AS AN ARTERIOTOMY CLOSURE OF THE HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. REPORTEDLY, THE PHYSICIAN COULD ONLY PARTIALLY OPEN THE FOOT. IT APPEARED THAT THE LINK WAS WRAPPED AROUND THE FOOT, PREVENTING IT FROM FULLY OPENING. THE FOOT WAS RECLOSED AND THE DEVICE WAS REMOVED WITHOUT INCURRING ANY VESSEL DAMAGE. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 12F AND THE TAVR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE 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
    1582118 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3060942 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention