BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18867860 · Received March 8, 2024

    Report

    Report Number
    2024168-2024-03010
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    February 20, 2024
    Report Date
    May 8, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE DIFFICULT TO REMOVE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE DIFFICULT TO OPEN OR CLOSE WAS CONFIRMED BASED ON THE RETURN CONDITION OF THE DEVICE. THE FAILURE TO CYCLE WAS CONFIRMED. 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 INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. THE DEVICE WAS REMOVED AGAINST RESISTANCE WITH THE FOOT OPEN. THE PERCLOSE PROSTYLE INSTRUCTIONS FOR USE (IFU), STATES, DO NOT ADVANCE OR WITHDRAW THE PERCLOSE PROSTYLE DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE PERCLOSE PROSTYLE DEVICE SHOULD BE AVOIDED, AS THIS MAY LEAD TO SIGNIFICANT VESSEL DAMAGE AND / OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE INTERVENTION AND / OR SURGICAL REMOVAL OF THE DEVICE AND VESSEL REPAIR. THE IFU VIOLATION DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. THE REPORTED PATIENT EFFECT OF TISSUE INJURY IS LISTED IN THE PERCLOSE PROSTYLE IFU, AS A KNOWN ADVERSE EVENT ASSOCIATED WITH USE OF SUTURE MEDIATED CLOSURE DEVICES THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENTS ARE DUE TO THE CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, THE ANTERIOR FOOT WAS FOUND NOT INTRALUMINAL AND WHEN CLOSED LIKELY CAPTURED CALCIFIED TISSUE WHICH CAUSED IT TO SURF DISTALLY DURING FOOT CLOSURE AND LOCKED IT INTO THAT POSITION. THIS CONDITION LIKELY LED TO THE TEARING OF VESSEL WHEN THE DEVICE WAS REMOVED WITH RESISTANCE. THE FAILURE TO CYCLE IS LIKELY CAUSED BY THE CALCIFICATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4: LOT # UPDATED FROM 4010241 TO 4011042. H4 - DEVICE MANUFACTURING DATE 1/2/2024 TO 1/10/2024.

    Additional Manufacturer Narrative · 0

    H6: MEDICAL DEVICE PROBLEM CODE 2017 ¿ AGAINST RESISTANCE. 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 WILL BE FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. REPORTEDLY, A PROSTYLE SUTURE DID NOT COME OUT WHEN THE DEVICE WAS DEPLOYED. THE ANTERIOR PORTION OF THE FOOTPLATE DID NOT RETRACT COMPLETELY. THE DEVICE WAS REMOVED AGAINST RESISTANCE WITH THE FOOT OPEN. THREE OTHER PROSTYLE DEVICES WERE NOTED TO HAVE THE FOOTPLATE NOT COMPLETELY RETRACT WHEN REMOVED. THE VESSEL WAS NOTED TO BE DAMAGED. THE SHEATH WAS UPSIZED TO 16F, AND THE TAVI PROCEDURE WAS COMPLETED. A VASCULAR PATCH TREATED THE VESSEL AND ACHIEVED HEMOSTASIS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: REPORTEDLY, FOUR OTHER PROSTYLE DEVICES WERE NOTED TO HAVE THE FOOTPLATE NOT COMPLETELY RETRACT WHEN REMOVED AGAINST RESISTANCE. THE VESSEL WAS NOTED TO BE DAMAGED BY THE FIVE PROSTYLE DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. REPORTEDLY, A PROSTYLE SUTURE DID NOT COME OUT WHEN THE DEVICE WAS DEPLOYED. THE ANTERIOR PORTION OF THE FOOTPLATE DID NOT RETRACT COMPLETELY. THE DEVICE WAS REMOVED AGAINST RESISTANCE WITH THE FOOT OPEN. THREE OTHER PROSTYLE DEVICES WERE NOTED TO HAVE THE FOOTPLATE NOT COMPLETELY RETRACT WHEN REMOVED. THE VESSEL WAS NOTED TO BE DAMAGED. THE SHEATH WAS UPSIZED TO 16F, AND THE TAVI PROCEDURE WAS COMPLETED. A VASCULAR PATCH TREATED THE VESSEL AND ACHIEVED HEMOSTASIS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060624 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 4011042 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention