BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 8478248 · Received April 3, 2019

    Report

    Report Number
    2210968-2019-79947
    Event Type
    Injury
    Date Received
    April 3, 2019
    Report Date
    March 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    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. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PDS II SUTURE, SECURESTRAP) 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 (PDS II SUTURE, SECURESTRAP) USED IN THIS PROCEDURE? CITATION: HERNIA (2018) 22:1015¿1022 / HTTPS://DOI.ORG/10.1007/S10029-018-1784-2. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE:LAPAROSCOPIC VERSUS HYBRID APPROACH FOR TREATMENT OF INCISIONAL VENTRAL HERNIA: A PROSPECTIVE RANDOMIZED MULTICENTER STUDY OF 1-MONTH FOLLOW-UP RESULTS" AUTHOR(S): M. AHONEN-SIIRTOLA · T. NEVALA · J. VIRONEN · J. KÖSSI · T. PINTA · S. NIEMELÄINEN · U. KERÄNEN · J. WARD · P. VENTO · J. KARVONEN · P. OHTONEN · J. MÄKELÄ · T. RAUTIO CITATION: HERNIA (2018) 22:1015¿1022 / HTTPS://DOI.ORG/10.1007/S10029-018-1784-2. THE PURPOSE OF THIS MULTICENTERED RANDOMIZED-CONTROLLED CLINICAL STUDY IS TO EVALUATE WHETHER HYBRID OPERATION HAS A LOWER RATE OF THE EARLY COMPLICATIONS COMPARED TO THE STANDARD LAPAROSCOPIC INCISIONAL VENTRAL HERNIA REPAIR (LIVHR). FROM NOV2012 TO MAY2015, A TOTAL OF 184 PATIENTS UNDERWENT LIVHR FOR PRIMARY INCISIONAL HERNIA WITH FASCIAL DEFECT SIZE FROM 2 TO 7 CM. THE PATIENTS WERE DIVIDED INTO TWO REPAIR GROUPS: LAPAROSCOPIC GROUP (LG) [N=94 (N=54 FEMALE, N=40 MALE, MEAN AGE 57 YEARS (SD 11.4 YEARS) BMI 30.2 KG/M2 (SD 4.4)] AND HYBRID GROUP (HG) [N=90 (N=54 FEMALE, N=36 MALE, MEAN AGE 60 YEARS (SD 12.8 YEARS) BMI 29.2 KG/M2 (SD 4.2)]. IN LG, SECURESTRAPP WAS USED TO SECURE THE MESH TO THE PERITONEUM BY DOUBLE CROWN TECHNIQUE. IN HG, THE HERNIA SACK WAS RESECTED, AND THE FASCIAL DEFECT WAS CLOSED WITH A SLOWLY ABSORBING MONOFILAMENT SUTURE 0¿0 MAXON OR PDS THROUGH A MINILAPAROTOMY INCISION BEFORE THE STANDARD MESH REPAIR. PERIOPERATIVE OUTCOMES INCLUDED ENTEROTOMY [N=6 (N=5 IN LG, N=1 IN HG)]; AND BLEEDING [N=5 (N=1 IN LG, N=4 IN HG)]. SHORT-TERM POSTOPERATIVE OUTCOMES INCLUDED PAIN FIRST POSTOP DAY [N=182 (N=94 IN LG, N=88 IN HG)]; PAIN SECOND POSTOP DAY [N=114 (N=55 IN LG, N=59 IN HG)]; PAIN THIRD POSTOP DAY [N=62 (N=29 IN LG, N=33 IN HG)]; WOUND INFECTION [N=5 (N=2 IN LG, N=3 IN HG)] WHICH ONE OF THESE PATIENTS (IN HG) WAS TREATED WITH VACUUM-ASSISTED THERAPY, AND FINALLY, THE WOUND WAS COVERED WITH A SKIN GRAFT (REOPERATION); WOUND DEHISCENCE (N=1 IN HG); INTRA-ABDOMINAL INFECTION [N=2 (N=1 IN LG, N=1 IN HG)] WHICH ONE OF THESE PATIENTS (UNDER HG) UNDERWENT A LAPAROTOMY WITH MESH REMOVAL (REOPERATION); SEROMA [N=6 (N=3 IN LG, N=3 IN HG)]; HEMATOMA [N=8 (N=4 IN LG, N=4 IN HG)]; AND INTESTINAL OBSTRUCTION [N=6 (N=4 IN LG, N=2 IN HG)]. ONE-MONTH CLINICAL OUTCOMES INCLUDED PAIN [N=57 (N=32 IN LG, N=25 IN HG)] WHICH 16 PATIENTS WERE READMITTED FOR PAIN (N=13 IN LG, N=3 IN HG) WHICH ONE OF THESE PATIENTS (IN HG) HAD PAIN IN THE AREA OF THE LATERAL TRANSABDOMINAL SUTURE, WHICH THE SUTURE WAS FOUND TO BE ENTANGLED WITH A SUBCUTANEOUS NERVE AND WAS REMOVED, EVENTUALLY PAIN WAS RELIEVED AFTERWARDS. CLINICAL FINDINGS INCLUDED WOUND INFECTION [N=2 (N=1 IN LG, N=1 IN HG)]; AND SEROMA [N=73 (N=46 IN LG, N=27 IN HG)]. RADIOLOGICAL FINDING INCLUDED SEROMA [N=102 (N=63 IN LG, N=39 IN HG)] WHICH 6 PATIENTS REQUIRED SEROMA PUNCTURE UNDER LG. CLOSURE OF THE FASCIAL DEFECT AND EXTIRPATION OF THE HERNIA SACK REDUCE SEROMA FORMATION. IN HYBRID OPERATIONS, THE RISK OF ENTEROTOMY SEEMS TO BE LOWER THAN IN LAPAROSCOPIC REPAIR, WHICH SHOULD BE CONSIDERED IN CASES WITH COMPLEX ADHESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273090 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PARIETEX MESH| SECURESTRAP| PARIETEX MESH| SECURESTRAP