BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7627224 · Received June 21, 2018

    Report

    Report Number
    2210968-2018-73645
    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
    US
    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 POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: ANN THORAC SURG. 2015; 100: 2320 4. DOI: HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2015.07.059 - [(B)(4) - ROBERTS 2015 (5).PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: EXPANDABLE VALVE FOR PEDIATRIC APPLICATION CONSTRUCTED FROM HUMAN VENOUS VALVED CONDUIT WITHIN A STENT" AUTHORS: ERIN G. ROBERTS, MS; LUIS QUINONEZ, MD; BREANNA PIEKARSKI, BSN; CHRISTOPHER W. BAIRD, MD; SITARAM M. EMANI, MD CITATION: ANN THORAC SURG. 2015; 100: 2320 4. DOI: HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2015.07.059. OPTIONS FOR PEDIATRIC VALVE REPLACEMENT ARE LIMITED BY INABILITY TO ADAPT TO CHILD GROWTH. AN EXPANDABLE VALVE DESIGN IS PRESENTED IN WHICH HUMAN CRYOPRESERVED VENOUS VALVED CONDUITS ARE CONSTRUCTED WITHIN A BARE-METAL STENT SCAFFOLD. THE AUTHORS DEMONSTRATED FUNCTIONALITY IN VITRO AND ACUTE COMPETENCE IN VIVO. IN PATIENT NUMBER 1, A (B)(6)-OLD CHILD WITH HYPOPLASTIC LEFT HEART SYNDROME AND BORDERLINE HYPOPLASIA OF THE LEFT VENTRICLE UNDERWENT STAGE 1 PALLIATION WITH AORTOPULMONARY AMALGAMATION, AORTIC ARCH RECONSTRUCTION, AND RESTRICTION OF THE INTERATRIAL SEPTUM. DURING THE PROCEDURE, THE SAPHENOUS VEIN CONSTRUCT WAS INTERPOSED WITHIN THE 2 SEGMENTS OF 5-MM POLYTETRAFLUOROETHYLENE (PTFE), AND THE ANASTOMOSES OF THE CONDUIT WALL TO THE PTFE GRAFT WERE PERFORMED WITH PROLENE 6-0 SUTURES. AT 4 MONTHS, ECHOCARDIOGRAPHY SHOWED THAT THE VALVE CONSTRUCT WAS BALLOON DILATED TO 8 MM ID IN THE CATHETERIZATION LABORATORY, RESULTING IN TRIVIAL-TO-MILD REGURGITATION. IN PATIENT NUMBER 2, A (B)(6) OLD GIRL WITH A HISTORY OF DOUBLE-OUTLET RV, TRANSPOSITION OF THE GREAT ARTERIES, PULMONARY ATRESIA, TOTAL ANOMALOUS PULMONARY VENOUS CONNECTION, AND DISCONTINUOUS PAS UNDERWENT STAGE 1 PALLIATION IN THE NEWBORN PERIOD. AN RV-PA CONDUIT WITH AN EXPANDABLE VALVED CONDUIT WAS PREFERRED TO PROMOTE ANTEGRADE PULMONARY BLOOD FLOW AND DELAY THE TIMING OF A BIVENTRICULAR CONVERSION. DURING THE PROCEDURE, THE ANASTOMOSES BETWEEN THE DISTAL SEGMENTS OF THE VEIN CONSTRUCT AND THE RIGHT PA AND THE PROXIMAL SEGMENT TO THE PTFE GRAFT WERE PERFORMED WITH PROLENE 6-0 SUTURES. ECHOCARDIOGRAPHY AT 2 WEEKS AND 1 MONTH POST-OPERATIVELY SHOWED TRIVIAL-TO-MILD REGURGITATION AT EACH ASSESSMENT. A CATHETERIZATION WILL BE PERFORMED FOR BALLOON DILATION OF THE VALVE IF THE PATIENT BECOMES CYANOTIC. THE STUDY DEMONSTRATED THE FEASIBILITY OF THIS EXPANDABLE VALVE DESIGN USING AN ALLOGRAFT VENOUS VALVED CONDUIT COMPRESSED WITHIN A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467800 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention