BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7824436 · Received August 28, 2018

    Report

    Report Number
    2210968-2018-75492
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PRODUCT (ETHIBOND SUTURE) 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 PRODUCT (ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: HERNIA (2017) 21:291¿298; DOI 10.1007/S10029-016-1486-6 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LONG-TERM RESULTS AND COMPLICATIONS RELATED TO CRURASOFT MESH REPAIR FOR PARAESOPHAGEAL HIATAL HERNIAS" AUTHOR(S): P. PRIEGO , J. PEREZ DE OTEYZA , J. GALINDO , P. CARDA1 , F. GARCI´A-MORENO , G. RODRI´GUEZ VELASCO , E. LOBO CITATION: HERNIA (2017) 21:291¿298; DOI 10.1007/S10029-016-1486-6 THE AIM OF THIS STUDY IS TO PRESENT OUR LONG-TERM RESULTS AND COMPLICATIONS RELATED TO CRURASOFT MESH (BARD) FOR THE TREATMENT OF LARGE AND PARAESOPHAGEAL HIATAL HERNIAS (LPHH). FROM JAN2004 TO DEC2014, 93 PATIENTS WITH GASTROESOPHAGEAL DISEASE OR LPHH UNDERWENT OPEN OR LAPAROSCOPIC FUNDOPLICATION WHERE PRIMARY SIMPLE SUTURE OF THE CRURA AND ADDITIONAL REINFORCEMENT WITH A CRURASOFT MESH (BARD) WERE PERFORMED. IN THIS TECHNIQUE, PRIMARY UROPLASTY WAS PERFORMED USING THREE-FOUR INTERRUPTED 0 ETHIBOND SUTURES; MESH WAS FIXED WITH 2-0 ETHIBOND SUTURES (N=91) AND AUTOSUTURE PROTACK (N=2); A ¿¿FLOPPY¿¿ NISSEN FUNDOPLICATION (N=86) WAS THEN TAILORED IN ALL THE PATIENTS USING THREE 2¿0 ETHIBOND STITCHES. EARLY COMPLICATIONS INCLUDED WOUND INFECTION (N=1) AND ANEMIA/BLEEDING (N=1). LATE COMPLICATIONS INCLUDED VOMITS AND DYSPHAGIA (N=5), VOMITS (N=3), WOUND BLEEDING (N=1), WOUND INFECTION (N=1) AND PYROSIS (N=1). ADDITIONALLY, A (B)(6) MALE PATIENT HAD REOPERATION OF HERNIA REDUCTION 20 DAYS AFTER THE PROCEDURE DUE TO INCARCERATED RECURRENCE HIATAL HERNIA WITH GASTRIC ISCHEMIA. MOREOVER, A (B)(6) FEMALE PATIENT ALSO HAD REOPERATION OF ESOPHAGOGASTROSTOMY AND JEJUNOSTOMY WITH REMOVAL OF MESH 5 MONTHS POST PROCEDURE DUE TO ESOPHAGEAL PERFORATION WITH MESH INCLUSION. FURTHERMORE, A (B)(6) FEMALE PATIENT ALSO HAD REOPERATION OF HERNIA REDUCTION AND GASTROSTOMY 5 MONTHS POST-SURGERY DUE TO INCARCERATED RECURRENCE HIATAL HERNIA. THE RECURRENCE RATE IN PATIENTS WITH A CRURASOFT (BARD) IS ACCEPTABLE. HOWEVER, THE RATE OF POSTOPERATIVE COMPLICATIONS AND MORTALITY IS EXCESSIVE. THE USE OF MESHES IN THE HIATUS KEEPS ON BEING CONTROVERSIAL DUE TO THE SEVERE COMPLICATIONS RELATED TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666081 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention