BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7627426 · Received June 21, 2018

    Report

    Report Number
    2210968-2018-73652
    Event Type
    Injury
    Date Received
    June 21, 2018
    Report Date
    May 30, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE SUTURE-LINE BLEEDING AND COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: J VASC SURG 2012;56:134-41; DOI: HTTP://DX.DOI.ORG/10.1016/J.JVS.2012.01.009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: A PROSPECTIVE RANDOMIZED STUDY COMPARING FIBRIN SEALANT TO MANUAL COMPRESSION FOR THE TREATMENT OF ANASTOMOTIC SUTURE-HOLE BLEEDING IN EXPANDED POLYTETRAFLUOROETHYLENE GRAFTS". AUTHOR(S): SIBU P. SAHA, MD, MBA,A SATISH MULUK, MD,B WORTHINGTON SCHENK, III, MD,C JAMES W. DENNIS, MD,D BETTINA PLODER, MS,E ANI GRIGORIAN, MFA,F ISABELLA PRESCH, MD, MBA,E AND ANDREAS GOPPELT, PHD. CITATION: J VASC SURG 2012;56:134-41; DOI: HTTP://DX.DOI.ORG/10.1016/J.JVS.2012.01.009. THE AIM OF THIS PROSPECTIVE, CONTROLLED, RANDOMIZED, SUBJECT BLINDED, MULTICENTER PHASE 3 STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF A FIBRIN SEALANT CONTAINING 500 IU/ML THROMBIN AND SYNTHETIC APROTININ (FIBRIN SEAKANT) FOR THE TREATMENT OF ANASTOMOTIC SUTURE HOLE BLEEDING THAT IS NOT AMENABLE TO ADDITIONAL SUTURES DURING PLACEMENT OF EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) VASCULAR GRAFTS. OVER A 1-YEAR PERIOD ENDING IN 2010, AMONG THE PATIENT WHO UNDERWENT VASCULAR RECONSTRUCTIVE SURGERY USING EPTFE GRAFT, 140 PATIENTS (AGED BETWEEN 33 AND 90 YEARS OLD) DEVELOPED SUTURE LINE BLEEDING AND WERE INCLUDED IN THE STUDY. SUTURES AND NEEDLES WERE STANDARDIZED FOR THE GRAFT ANASTOMOSES WHICH INCLUDED 5-0 PROLENE SUTURES AND C-1 NEEDLES FOR ARTERIO-ARTERIAL ANASTOMOSES (N=67); AND 6-0 PROLENE SUTURES AND RB-2 NEEDLES FOR ARTERIOVENOUS SHUNT (N=73). UPON COMPLETION OF THE BLEEDING ASSESSMENT, THE PATIENTS WERE RANDOMIZED INTO TWO TREATMENT GROUPS FOR BLEEDING MANAGEMENT: THE FIBRIN SEALANT GROUP (N=70) AND THE CONTROL GROUP (N=70). IN THE FS GROUP, A THIN, CONTINUOUS FILM OF FS WAS APPLIED WITH A BLUNT APPLICATION NEEDLE TO THE STUDY SUTURE LINE, COVERING BOTH THE NATIVE VESSEL AND EPTFE GRAFT; ARTERIAL FLOW WAS RE-ESTABLISHED AFTER 2 MINUTES OF POLYMERIZATION OR SETTING OF FS. IN THE CONTROL GROUP, DRY GAUZE PADS WERE POSITIONED TO COMPLETELY COVER THE STUDY SUTURE LINE; ARTERIAL FLOW WAS RE-ESTABLISHED IMMEDIATELY AFTER GAUZE PADS WERE POSITIONED AND MANUAL COMPRESSION WAS APPLIED. TREATMENT OF INTRAOPERATIVE REBLEEDING INCLUDED REAPPLICATION OF FS, MANUAL COMPRESSION, ADDITIONAL SUTURES, THROMBIN-SOAKED GELFOAM, SURGICEL, AND OTHER TOPICAL HEMOSTATIC AGENTS SUCH AS FIBRILLAR AND FLOSEAL SEVERAL FACTORS MAY INFLUENCE THE RATE OF GRAFT OCCLUSIONS AND INFECTIONS, INCLUDING PATIENTS¿ UNDERLYING DISEASE AND THEIR PROGRESSION, COMORBIDITIES, SURGICAL TECHNIQUE, HISTORY OF PREVIOUS GRAFT PLACEMENT, GRAFT MATERIALS USED, ANATOMIC FEATURES, ANTIBIOTIC PROPHYLAXIS, AND WOUND MANAGEMENT. THE OCCURRENCE OF GRAFT OCCLUSIONS AND SSIS WAS SIMILAR BETWEEN TREATMENT GROUPS, CONFIRMING THAT WOUND INFECTION ARE A COMMON CAUSE OF MORBIDITY IN OPEN SURGERY FOR VASCULAR DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467841 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention