BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18529543 · Received January 17, 2024

    Report

    Report Number
    2024168-2024-00930
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 20, 2023
    Report Date
    March 13, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    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 DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE REPORTED ¿NO SUTURE WAS PRESENT DURING STEP 3 WHEN THE PLUNGER WAS REMOVED¿ WAS OBSERVED AS A SUTURE RETRIEVAL ISSUE. A REVIEW OF THE MANUFACTURING RECORDS 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4 - LOT # UPDATED FROM 3010641 TO 3022041. H6: MEDICAL DEVICE PROBLEM CODE 2610 WAS REMOVED AND REPLACED WITH 1142.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE OF AN UNKNOWN VESSEL USING A PROSTYLE DEVICE FOR A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PROSTYLE COULD NOT BE TRIGGERED [FAIL TO DEPLOY] DURING THE PROCEDURE. ANOTHER PROSTYLE WAS USED BUT THE SAME OCCURRED. ANOTHER PROSTYLE 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

    IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE OF AN UNKNOWN VESSEL USING A PROSTYLE DEVICE FOR A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PROSTYLE COULD NOT BE TRIGGERED [FAIL TO DEPLOY] DURING THE PROCEDURE. ANOTHER PROSTYLE WAS USED BUT THE SAME OCCURRED. ANOTHER PROSTYLE 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. SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, THE ACCOUNT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED LEFT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE. REPORTEDLY, DURING STEP 3 WHEN THE PLUNGER WAS REMOVED, NO SUTURE WAS PRESENT. ANOTHER PROSTYLE WAS USED BUT THE SAME OCCURRED. THE SUTURES OF TWO NEW PROSTYLES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO AN UNSPECIFIED SHEATH SIZE AND THE PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628086 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3022041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention