BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7599571 · Received June 13, 2018

    Report

    Report Number
    2210968-2018-73472
    Event Type
    Injury
    Date Received
    June 13, 2018
    Report Date
    May 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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: THE AMERICAN JOURNAL OF CASE REPORTS. 2008; 9: 192 195.[(B)(4) - SAKALAUSKAS 2008.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: A LEFT VENTRICULAR FREE WALL RE-RUPTURE AFTER SURGERY OF VENTRICULAR RUPTURE DUE TO ACUTE MYOCARDIAL INFARCTION: CASE REPORT AUTHORS: JUOZAS SAKALAUSKAS, SARUNAS KINDURIS, EDMUNDAS SIRVINSKAS CITATION: THE AMERICAN JOURNAL OF CASE REPORTS. 2008; 9: 192 195. LEFT VENTRICULAR FREE WALL RUPTURE (LVFWR) FOLLOWING MYOCARDIAL INFARCTION IS A COMPARATIVELY COMMON CAUSE OF DEATH. THE MOST APPROPRIATE SURGICAL TECHNIQUE REMAINS CONTROVERSIAL BECAUSE EXPERIENCE IN TREATING THIS PATHOLOGY IS LIMITED. A (B)(6)-YEAR-OLD MAN WAS PRESENTED TO THE HOSPITAL WITH SEVERE CHEST PAIN AND CARDIAC TAMPONADE WITH CARDIOGENIC SHOCK. THE PATIENT WAS DIAGNOSED WITH VENTRICULAR RUPTURE AND CARDIAC TAMPONADE AND WAS IMMEDIATELY TRANSFERRED TO THE OPERATING ROOM. MEDIAN STERNOTOMY WAS PERFORMED, AND 500 ML OF FRESH BLOOD AND CLOTS WERE REMOVED FROM THE PERICARDIUM. AN INFARCTED AREA, 3×5 CM IN SIZE, IN THE LEFT VENTRICULAR LATERAL WALL WITHOUT OBVIOUS ORIFICE OF RUPTURE WAS FOUND. USING OFF-PUMP CORONARY BYPASS TECHNIQUE, THE REPAIR WAS PERFORMED WITH PERICARDIAL PATCH, WHICH WAS FIXED ON THE WALL OF THE LEFT VENTRICLE USING CONTINUOUS PROLENE 4-0 SUTURE. ON POSTOPERATIVE DAY 3, MASSIVE BLEEDING BEGAN THROUGH THE CHEST TUBE AND AN EMERGENCY STERNOTOMY WAS PERFORMED AGAIN. BLOOD AND CLOTS WERE EVACUATED FROM THE PERICARDIAL CAVITY FOLLOWED BY ESTABLISHMENT OF CARDIOPULMONARY BYPASS. DURING THE RE-OPERATION, NECROSIS OF THE MYOCARDIUM ALONG THE FIRST MARGINAL CORONARY ARTERY WAS FOUND. AFTER INCISION IN THE MIDDLE OF THE NECROTIC MYOCARDIUM, THE LEFT VENTRICLE WAS OPENED WITHOUT EXCISION OF NECROTIC TISSUE AND WAS CAREFULLY INSPECTED. TWELVE SEPARATE PLEDGETS AT THE BORDER OF THE NECROTIC TISSUE WERE PLACED. TEFLON PATCH WAS APPLIED OVER THE NECROTIC AREA. THE CORNERS OF THE TEFLON PATCH WAS SUTURED USING EARLIER INSERTED SUTURES AROUND ALL NECROTIC MYOCARDIUM. THE POSTOPERATIVE PERIOD WAS SUCCESSFUL. IT WAS CONCLUDED THAT THE SURGICAL REPAIR OF LEFT VENTRICULAR FREE WALL RUPTURE WITH PERICARDIAL PATCH FIXED TO EPICARDIUM USING SUTURES IS NOT SAFE TECHNIQUE AND DOES NOT PREVENT RE-RUPTURE. SURGICAL REPAIR OF LEFT VENTRICULAR MUSCLE RUPTURE WITH A PROSTHETIC PATCH SUTURED AT THE BORDERS OF INTACT TISSUE USING EARLIER INSERTED SUTURES SIGNIFICANTLY PREVENTS FURTHER TEARING OF DEAD MYOCARDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441743 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention