BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7606521 · Received June 15, 2018

    Report

    Report Number
    2210968-2018-73506
    Event Type
    Injury
    Date Received
    June 15, 2018
    Report Date
    May 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY. 2014; 18: 842 843 DOI: DOI:10.1093/ICVTS/IVU028 - [(B)(4) - MALANKAR 2014.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: SEVERE MITRAL REGURGITATION AFTER INTRACARDIAC REPAIR OF TETRALOGY OF FALLOT: A RARE COMPLICATION AND MANAGEMENT" AUTHORS: DHANANJAY MALANKAR, VINITHA VISWAMBHARAN NAIR, SAURABH KUMAR GUPTA, SAMBHUNATH DAS, BALRAM AIRAN CITATION: INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY. 2014; 18: 842 843 DOI: DOI:10.1093/ICVTS/IVU028. THE AUTHORS REPORTED AN UNFORESEEN OCCURRENCE OF TRAUMATIC ACUTE SEVERE MITRAL REGURGITATION (MR) AFTER TETRALOGY OF FALLOT (TOF) REPAIR POSSIBLY DURING CLOSURE OF ADDITIONAL MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD). THE AUTHORS DISCUSSED THE POSSIBLE MECHANISM OF THIS UNPRECEDENTED COMPLICATION, WHICH WAS PROMPTLY DIAGNOSED AND MANAGED WITH GOOD SURGICAL OUTCOMES. A (B)(6)-YEAR-OLD GIRL WITH A DIAGNOSIS OF TOF WITH ADDITIONAL MUSCULAR VSD UNDERWENT SURGICAL CORRECTION. DURING THE PROCEDURE, THE ADDITIONAL MUSCULAR VSD PRESENT WAS CLOSED WITH PLEDGETED PROLENE 5-0 SUTURE. THE INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) IMMEDIATELY AFTER THE SURGERY DID NOT SHOW ANY RESIDUAL VSD OR RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) GRADIENT BUT A TRIVIAL MR OF UNCERTAIN ETIOLOGY WAS EVIDENT. ON POSTOPERATIVE DAY 9, TRANSTHORACIC ECHOCARDIOGRAM REVEALED SEVERE MR SECONDARY TO CHORDAL RUPTURE LEADING TO FLAIR ANTERIOR MITRAL LEAFLET. ON CLOSE EVALUATION, IT WAS SEEN THAT THE PROLENE SUTURE USED FOR CLOSURE OF ADDITIONAL MUSCULAR VSD FROM THE RIGHT VENTRICULAR SIDE HAD TRAPPED THE TIP OF THE ANTEROLATERAL PAPILLARY MUSCLE ON THE LEFT VENTRICULAR (LV) SIDE. A REPEAT SURGERY WAS PERFORMED. TWO NEOCHORDAE WERE CONSTRUCTED WITH POLYTETRAFLUOROETHYLENE 6¿0 SUTURES AND FIXED OVER THE TIP OF PAPILLARY MUSCLE AND USED TO SUSPEND THE A1 AND P1 SEGMENT OF THE MITRAL VALVE WITH THE HELP OF PLEDGETS. THE ANTEROLATERAL COMMISSUROPLASTY WAS DONE WITH PLEDGETED PROLENE 5¿0 SUTURE. THE MUSCULAR VSD WAS CLOSED WITH PLEDGETED 5¿0 PROLENE SUTURES. THE INTERATRIAL SEPTUM AND RIGHT ATRIAL INCISION WERE CLOSED AND AORTIC CROSS CLAMP RELEASED AFTER DEAIRING. POSTOPERATIVE TOE SHOWED TRIVIAL-TO-MILD MR, NO MITRAL STENOSIS OR RESIDUAL VSD AND NORMAL LV FUNCTION. THE POSTOPERATIVE COURSE WAS UNEVENTFUL WITH TRIVIAL MR, NO MITRAL STENOSIS, AND NORMAL LV FUNCTION. IT WAS REPORTED THAT THE TRAUMATIC ENTRAPMENT OF THE MITRAL VALVE APPARATUS MUST HAVE HAPPENED DURING CLOSURE OF THE MUSCULAR VSD. THE AUTHORS STRONGLY FEEL THAT THE COLLAPSED VENTRICLE DISPLACING THE PAPILLARY MUSCLE MAY BE THE REASON FOR IT BEING CAUGHT IN THE SUTURE. THE PRESENCE OF TRIVIAL MR VISUALIZED DURING TOE AFTER THE FIRST SURGERY MIGHT HAVE BEEN DUE TO TRAPPED ANTEROLATERAL PAPILLARY MUSCLE, FUNCTIONALLY IMPAIRING COMPLETE MITRAL VALVE CLOSURE. THE AUTHORS POSTULATED THAT THE ADDITIONAL MUSCULAR VSD STITCH HAD ACCIDENTALLY TRAPPED THE TIP OF THE ANTEROLATERAL PAPILLARY MUSCLE, WHICH LATER ON MUST HAVE GIVEN WAY DUE TO THE INCREASED CONTRACTILE FORCE OF THE LEFT VENTRICLE AS THE CHILD BECAME MORE ACTIVE RESULTING IN RUPTURED CHORDAE, LEADING TO SEVERE MR. THIS CASE HIGHLIGHTS THE IMPORTANCE OF CAREFUL VISUALIZATION AND SUTURE PLACEMENT WHILE CLOSING MUSCULAR VSD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447542 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention