BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7397540 · Received April 4, 2018

    Report

    Report Number
    2210968-2018-71898
    Event Type
    Injury
    Date Received
    April 4, 2018
    Report Date
    March 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS 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? IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC PRODUCT CODE. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE AND TYPE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR ETHICON DEVICES USED? DOI 10.1007/S10029-017-1602-2. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: A MODIFIED CHEVREL TECHNIQUE FOR VENTRAL HERNIA REPAIR: LONG-TERM¿ RESULTS OF A SINGLE CENTRE COHORT AUTHORS: E. H. H. MOMMERS, B. J. M. LEENDERS, W. K. G. LECLERCQ, T. S. DE VRIES REILINGH, J. A. CHARBON DOI 10.1007/S10029-017-1602-2. THE PURPOSE OF THIS COMPARATIVE RETROSPECTIVE, SINGLE SURGEON, SINGLE CENTER COHORT STUDY WAS TO EVALUATE THE SHORT AND LONG-TERM RESULTS AFTER A MODIFIED CHEVREL TECHNIQUE FOR MIDLINE INCISIONAL HERNIA REPAIR, REGARDING SURGICAL TECHNIQUE, HOSPITAL STAY, WOUND COMPLICATIONS, RECURRENCE RATE AND POSTOPERATIVE QUALITY OF LIFE AS COMPARED TO THE LITERATURE DERIVED REFERENCE VALUES REGARDING THE ORIGINAL AND MODIFIED CHEVREL TECHNIQUES. BETWEEN 2000 AND 2012, 155 PATIENTS, 84 MALES AND 71 FEMALES, RECEIVING A MIDLINE INCISIONAL HERNIA REPAIR USING THE MODIFIED CHEVREL TECHNIQUE WERE INCLUDED IN THIS STUDY. ANTIBIOTIC PROPHYLAXIS WAS GIVEN INTRAVENOUSLY. THE LEFT AND RIGHT ¿TURNED OVER¿ ANTERIOR FASCIA CAN NOW BE SUTURED IN THE MIDLINE WITH A CONTINUOUS 2/0 POLYDIOXANONE (PDS) SUTURE USING SMALL BITES. THE SECOND LAYER WAS FORMED BY A POLYPROPYLENE MESH (PROLENE_, ETHICON INC.) SUTURED TO THE EDGE OF THE LATERAL PART OF THE ANTERIOR FASCIA USING TWO LONG DOUBLE NEEDLED PROLENE_ 2/0 SUTURES. ONE TIED SUTURE FIXES THE MESH AT THE CRANIAL AND ONE AT THE CAUDAL MEETING POINT OF THE LEFT AND RIGHT LATERAL PART OF THE ANTERIOR RECTUS FASCIA. THE RIM WAS THEN SUTURED TO THE VENTRAL SIDE OF THE ANTERIOR RECTUS FASCIA USING SINGLE PROLENE 2/0 SUTURES. WITHIN 30 DAYS POSTOPERATIVE 36 PATIENTS HAD 39 POSTOPERATIVE COMPLICATIONS OF WHICH 30 WERE MILD (CDC I¿II), AND NINE SEVERE (CDC III¿IV). THIRTY-ONE SURGICAL SITE OCCURRENCES WERE OBSERVED IN 30 PATIENTS OF WHICH 16 WERE SEROMA PATIENTS. EIGHT SEROMAS REQUIRED FINE NEEDLE-ASPIRATION, ONE WAS DRAINED UNDER LOCAL ANAESTHETIC, FIVE REQUIRED REINTERVENTIONS (INCLUDING TWO REINTERVENTIONS 1 YEAR POSTOPERATIVE DUE TO RECURRENT SEROMA FORMATION), AND TWO DISAPPEARED SPONTANEOUSLY. THREE OF THE NINE SEVERE COMPLICATIONS WITHIN 30 DAYS WERE SEROMA¿S REQUIRING REINTERVENTION, TWO WERE ABSCESSES, TWO WERE SEVERE WOUND INFECTIONS, ONE WAS A POSTOPERATIVE BLEEDING, AND ONE WAS AN ANASTOMOTIC LEAKAGE IN A PATIENT WITH CONCOMITANT ILEOSTOMY TAKEDOWN. THE REVISION OF THE ANASTOMOTIC LEAKAGE WAS COMPLICATED BY A MASSIVE BLEEDING, THOUGH AFTER RE-INTERVENTION AN UNEVENTFUL RECOVERY FOLLOWED. IN CONCLUSION, THESE RESULTS EXCEEDED THE RESULTS PUBLISHED ON THE ORIGINAL CHEVREL TECHNIQUE, INDICATING THAT THIS MODIFIED CHEVREL TECHNIQUE LEADS TO FAVOURABLE RESULTS, AND SHOULD HAVE A PLACE IN MODERN VENTRAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240706 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention