BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7664720 · Received July 5, 2018

    Report

    Report Number
    2210968-2018-74102
    Event Type
    Injury
    Date Received
    July 5, 2018
    Report Date
    June 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: ANN VASC SURG. 2009; 23: 686.E11 686.E16. DOI: 10.1016/J.AVSG.2009.02.005. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : TOTAL LAPAROROBOTIC REPAIR OF ABDOMINAL AORTIC ANEURYSM WITH SAC EXCLUSION OBLITERATION AND AORTOBIFEMORAL BYPASS. AUTHOR : TIMOTHY WU, JATEEN PREMA, GREGORY ZAGAJA, ARIEH SHALHAV, AND HISHAM S. BASSIOUNY.A. CITATION: ANN VASC SURG. 2009; 23: 686.E11 686.E16. DOI: 10.1016/J.AVSG.2009.02.005. A (B)(6) MAN WITH CORONARY ARTERY DISEASE, HYPERTENSION, AND PERIPHERAL VASCULAR DISEASE PRESENTED WITH AN INCIDENTALLY FOUND ASYMPTOMATIC ABDOMINAL AORTIC ANEURYSM (AAA) MEASURING 5.5 CM. THE PATIENT AGREED TO A LAPAROROBOTIC REPAIR BECAUSE OF THE MINIMALLY INVASIVE NATURE OF THE PROCEDURE, MARKEDLY LESS INCISIONAL PAIN, AND FASTER POSTOPERATIVE RECOVERY TIME. DURING THE PROCEDURE, A SUFFICIENT RETRO-AORTIC SPACE WAS DEVELOPED TO INTRODUCE A 4.5 CM ADJUSTABLE VASCULAR STAPLER ACROSS THE INFRARENAL AORTA. ANOTHER VASCULAR STAPLER WAS FIRED DISTAL TO THE ANEURYSM AND PROXIMAL TO THE AORTIC BIFURCATION TO COMPLETELY EXCLUDE THE SAC. THE PROXIMAL AORTIC NECK WAS COMPLETELY TRANSECTED ABOVE THE STAPLE LINE, AND THE PROXIMAL ANASTOMOSIS WAS COMPLETED IN A RUNNING FASHION, END-TO-END ON THE AORTA WITH PLEDGETED REINFORCEMENT. FINALLY, A PROLENE 1-0 SUTURE ON A LARGE 7.5 CM CTX-B CURVED CUTTING NEEDLE WAS PASSED TRANSCUTANEOUSLY INTO THE ABDOMEN AND THE AAA SAC WAS OBLITERATED. TO PERFORM THE CERCLAGE, THE NEEDLE WAS PASSED THROUGH THE SAC THREE TIMES, WITH A SEPARATION OF 60 DEGREES BETWEEN EACH PASS OF THE SUTURE. THIS WAS REPEATED WITH TWO ADDITIONAL SUTURES AT EQUIDISTANT POINTS ALONG THE LENGTH OF THE ANEURYSM. THE SUTURES WERE TIED DOWN OVER PLEDGETS SEQUENTIALLY TO COLLAPSE THE ANEURYSM SAC ON ITSELF. AT HIS 3-WEEK POST-OPERATIVE FOLLOW-UP THE PATIENT HAD A MINOR WOUND INFECTION OF THE LEFT GROIN, WHICH DID NOT INVOLVE THE GRAFT AND HEALED WITH CONSERVATIVE MANAGEMENT AND ANTIBIOTICS. IT WAS CONCLUDED THAT THE LAPAROROBOTIC AAA REPAIR BY EXCLUSION AND AORTO-BIFEMORAL BYPASS HAS THE POTENTIAL TO EVOLVE INTO A VIABLE, MINIMALLY INVASIVE ALTERNATIVE TO OPEN REPAIR WHICH OFFERS A DURABLE RECONSTRUCTION FOR INFRARENAL AAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506500 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention