BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7782784 · Received August 14, 2018

    Report

    Report Number
    2210968-2018-75151
    Event Type
    Injury
    Date Received
    August 14, 2018
    Report Date
    July 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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 POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (ETHIBOND OR PROLENE SUTURE) USED IN THIS PROCEDURE? CITATION: ANN THORAC SURG 2017;103:504¿10; DOI: HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2016.06.072. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: SUTURE ANNULOPLASTY SIGNIFICANTLY IMPROVES THE DURABILITY OF BICUSPID AORTIC VALVE REPAIR AUTHOR: ULRICH SCHNEIDER, MD, CHRISTOPHER HOFMANN, DIANA AICHER, MD, HIROAKI TAKAHASHI, MD, YUJIRO MIURA, MD, AND HANS-JOACHIM SCHAFERS, MD. CITATION: ANN THORAC SURG 2017;103:504¿10; DOI: HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2016.06.072. THE PURPOSE OF THIS STUDY WAS TO ANALYZE THE MIDTERM RESULTS USING THE ANNULOPLASTY IN ISOLATED BICUSPID AORTIC VALVE (BAV) REPAIR. BETWEEN JAN 2009 AND SEP 2014, 164 PATIENTS (N=155 MALE AND N=9 FEMALE; MEAN SD AGE OF 39±12 YEARS) UNDERWENT ISOLATED BAV REPAIR FOR SEVERE REGURGITATION. IF THE BASAL RING WAS LARGER THAN 26MM, SUTURE ANNUPLASTY WAS PERFORMED TO REDUCE DILATATION. IN THE BAV REPAIR, THE PATCH WAS TRIMMED AND INSERTED INTO THE TISSUE DEFECT OF THE FUSED CUSP USING A CONTINUOUS 5-0 PROLENE SUTURE. IN SUTURE ANNUPLASTY, 37 PATIENTS USED ETHIBOND 2 SUTURES AND THE REMAINING 127 USED EXPANDED POLYTETRAFLUORETHYLENE (PTFE). POSTOPERATIVELY, COMPLICATIONS INCLUDED RECURRENT PROLAPSE OF THE FUSED CUSP (N=1), PLICATION SUTURE DEHISCENCE (N=1) AND LOCAL EROSION WITH RECURRENT ANNULAR DILATATION (N=2). THESE WERE TREATED WITH REOPERATION WHERE RE-REPAIR WAS POSSIBLE IN 2 PATIENTS AND VALVE REPLACEMENT WAS PERFORMED ON THE OTHER 2 PATIENTS. SUTURE ANNUPLASTY RELATED COMPLICATIONS WAS RECORDED IN 6 PATIENTS (N=4 OF WHICH USED ETHIBOND SUTURES) WHERE 2 PATIENTS WERE TREATED WITH A VENTRICULAR SEPTAL DEFECT CLOSURE AND 4 PATIENTS REQUIRED REMOVAL OF SUTURE ANNUPLASTY WITHIN SEVERAL HOURS BECAUSE OF INTERFERENCE WITH THE CIRCUMFLEX ARTERY. ONE OF THESE PATIENTS VALVE REPLACEMENT WAS PERFORMED DUE TO CONCOMITANT RECURRENT AORTIC REGURGITATION. ANNULAR DILATATION IS A RISK FACTOR FOR FAILURE AFTER REPAIR OF REGURGITANT BAV. ITS ELIMINATION THROUGH THE USE OF SA SIGNIFICANTLY IMPROVES REPAIR STABILITY. WITH PTFE AS MATERIAL FOR SA OPTIMAL REPAIR STABILITY AND MINIMAL LOCAL COMPLICATIONS ARE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624212 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention