BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18699653 · Received February 13, 2024

    Report

    Report Number
    2024168-2024-01773
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    January 22, 2024
    Report Date
    April 2, 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
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED GUIDE SEPARATION WAS CONFIRMED BASED ON THE RETURNED DEVICE CONDITION. THE REPORTED DEVICE ENTRAPMENT COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. ELECTRONIC LOT HISTORY RECORD (ELHR) AND EXCEPTION REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION DETERMINED THAT THE REPORTED DEVICE ENTRAPMENT, GUIDE SEPARATION AND UNEXPECTED MEDICAL INTERVENTION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. IT IS POSSIBLE THAT THERE WAS AN INTERACTION WITH THE FIRST DEPLOYED SUTURE SUCH THE SUTURE WAS CAUGHT IN THE FOOT OF THIS DEVICE. THIS INTERACTION LIKELY CONTRIBUTED TO THE REPORTED DEVICE ENTRAPMENT. SUBSEQUENT HANDLING DURING THE MULTIPLE ATTEMPTS TO THE REMOVE THE DEVICE LIKELY CONTRIBUTED TO THE OBSERVED STRETCHING OF THE SHEATH AND ULTIMATELY, SEPARATION OF THE GUIDE. 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. CORRECTION. D4 - LOT NUMBER UPDATED FROM 3102241 TO 3051041. D4 EXPIRATION DATE AND H4 MANUFACTURING DATE UPDATED AS RESULT.

    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

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROSTYLE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO AN INTERVENTIONAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. REPORTEDLY, THE SUTURE OF A PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE SUTURE OF A SECOND PROSTYLE DEVICE WAS ATTEMPTED TO BE PRE-PLACED; HOWEVER, AFTER COMPLETING ALL STEPS, THE DEVICE WAS UNABLE TO BE REMOVED FROM THE PATIENT'S ANATOMY. AFTER MULTIPLE ATTEMPTS TO REMOVE THE DEVICE, THE DISTAL GUIDE SEPARATED FROM THE REST OF THE DEVICE. THE SEPARATED PORTION OF THE DEVICE WAS REMOVED VIA A SNARE WIRE. DUE TO THE ISSUE WITH THIS DEVICE, THE DECISION WAS MADE TO CHANGE THE METHOD OF CLOSURE AND THE PRE-CLOSE TECHNIQUE WAS ABANDONED. THE EVAR PROCEDURE WAS COMPLETED WITH THE 6F SHEATH. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. 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
    1283331 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3051041 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention VESSEL CLOSURE DEVICE: PROSTYLE SUTURE