BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7664759 · Received July 5, 2018

    Report

    Report Number
    2210968-2018-74105
    Event Type
    Injury
    Date Received
    July 5, 2018
    Report Date
    June 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 PRODUCT (PROLENE / VICRYL/ ETHIBOND SUTURE)S USED IN THIS PROCEDURE? CITATION: HERNIA. 2013; 17: 589 596. DOI: 10.1007/S10029-013-1115-6 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: CLOSURE VERSUS NON-CLOSURE OF HERNIA DEFECT DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH" AUTHORS: M. S. ZEICHEN, H. J. LUJAN, W. N. MATA, V. H. MACIEL, D. LEE, I. JORGE, G. PLASENCIA, E. GOMEZ, A. M. HERNANDEZ CITATION: HERNIA. 2013; 17: 589 596. DOI: 10.1007/S10029-013-1115-6 THE PURPOSE OF THIS STUDY WAS TO REVIEW THE AUTHOR¿S EXPERIENCE WITH LAPAROSCOPIC VENTRAL HERNIA REPAIR AND COMPARE THE RESULTS WITH ¿¿NON-CLOSURE¿¿ OR USE OF MESH ALONE AGAINST LAPAROSCOPIC SUTURED HERNIA DEFECT ¿¿CLOSURE¿¿ WITH MESH REINFORCEMENT. THIS IS A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR FOR SMALL- AND MEDIUM SIZED HERNIAS BETWEEN JULY 2000 AND SEPTEMBER 2011. THE PATIENTS WERE DIVIDED INTO REPAIR WITH MESH ALONE (NON-CLOSURE GROUP; 93 PATIENTS [38 MALES AND 55 FEMALES]; MEAN AGE WAS 63 YEARS [RANGE 26 TO 91 YEARS OLD]; AVERAGE BMI WAS 30 [RANGE 20 TO 52]; AVERAGE ASA WAS 2.3 [RANGE 1 TO 4]). ELEVEN PATIENTS WERE UNDERGOING THE REPAIR FOR A RECURRENCE OF VENTRAL HERNIA. THOSE WITH HERNIA DEFECT CLOSURE AND MESH REINFORCEMENT (CLOSURE GROUP; 35 PATIENTS [15 MALES AND 20 FEMALES]; MEAN AGE WAS 63 YEARS [RANGE 27 TO 80 YEARS OLD]; AVERAGE BMI WAS 32 [RANGE 21 TO 71]; AVERAGE ASA WAS 2.24 (RANGE 1 TO 4). SIX PATIENTS WERE UNDERGOING THE REPAIR FOR A RECURRENCE OF VENTRAL HERNIA. DURING THE SURGICAL PROCEDURE IN THE NON-CLOSURE GROUP, AFTER COMPLETION OF THE DISSECTION, THE HERNIA DEFECT WAS MEASURED, AND A MESH CHOSEN TO OVERLAP ALL MARGINS OF THE DEFECT BY AT LEAST 3 TO 5 CM. FOR LARGER HERNIAS, PROLENE 0 STAY SUTURES WERE PLACED AT FOUR CORNERS OF THE MESH AND RETRIEVED INDIVIDUALLY WITH A SUTURE PASSER TO PROVIDE FASCIAL FIXATION. THE FASCIA FOR ANY EXPOSED 12-MM PORT SITE WAS ROUTINELY CLOSED WITH VICRYL 0 SUTURE AND SKIN INCISIONS WERE CLOSED IN SUBCUTICULAR FASHION. IN THE CLOSURE GROUP, THE TECHNIQUE USED IS THE SAME WITH THE NON-CLOSURE GROUP. THE DIFFERENCE WAS THAT THE AUTHORS PERFORMED A PRIMARY APPROXIMATION OF THE FASCIAL EDGES OF THE HERNIA DEFECT WITH ETHIBOND POLYESTER SUTURES PRIOR TO MESH PLACEMENT USING ONE OF 3 TECHNIQUES. IN THE NON-CLOSURE GROUP, REPORTED COMPLICATIONS INCLUDED SEPSIS (N-1), PARTIAL SMALL BOWEL OBSTRUCTION (N-2) IN WHICH 1 PATIENT IMPROVED AFTER MEDICAL TREATMENT AND THE OTHER PATIENT REQUIRED RE-OPERATION BECAUSE OF ASSOCIATED BOWEL PERFORATION, SEROMA (N-4), INFECTIOUS COLITIS (N-1), ILEUS (N-2), ENTEROTOMIES (N-3) WHICH REQUIRED RE-OPERATION, AND RECURRENT HERNIA (N-14). IN THE CLOSURE GROUP, REPORTED COMPLICATIONS INCLUDED SEROMA (N-4) IN WHICH THOSE SEROMAS WERE SELF-LIMITED AND ALL HAD DISAPPEARED BY 6 WEEKS POSTOPERATIVELY, ILEUS (N-1), RECURRENT HERNIA (N-2), PARTIAL SMALL BOWEL OBSTRUCTION (N-1) IN WHICH THE PATIENT IMPROVED AFTER MEDICAL TREATMENT, AND A SMALL BOWEL OBSTRUCTION SECONDARY TO INCARCERATED SMALL BOWEL BETWEEN THE ANTERIOR ABDOMINAL WALL AND THE MESH (N-1); THE PATIENT WAS RE-ADMITTED, THE LOOP WAS EASILY REDUCED AND IT WAS VIABLE WITH NO EVIDENCE OF STRANGULATION. THE MESH WAS RE-ATTACHED TO THE ABDOMINAL WALL AND REINFORCED WITH A SECOND MESH IN THAT AREA. IT WAS REPORTED THAT 6 DAYS POST-OPERATIVELY, THE PATIENT EXPIRED. INTRA-OPERATIVE FINDINGS DID NOT CORRELATE WITH THE PATIENT¿S CLINICAL DETERIORATION. IT WAS CONCLUDED THAT THE RESULTS ARE ENCOURAGING AND DEMONSTRATE THE SAFETY AND FEASIBILITY OF HERNIA DEFECT CLOSURE. THE AUTHORS LOOK FORWARD TO REPORTING A LONGER FOLLOW-UP IN THIS GROUP OF PATIENTS IN 3 TO 5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505276 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention