BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP UNKNOWN PRODUCT

    MDR report key: 11841584 · Received May 18, 2021

    Report

    Report Number
    2210968-2021-04738
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    October 16, 2020
    Report Date
    May 11, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO CLARIFY 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 ANY OF THE 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 ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? (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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. EVENTS RELATED TO PHYSIOMESH CAPTURED VIA 2210968-2021-04737. EVENTS RELATED TO PDS II CAPTURED VIA 2210968-2021-04739. EVENTS RELATED TO ETHIBOND SUTURE CAPTURED VIA 2210968-2021-04740. EVENTS RELATED TO PROLENE SUTURE CAPTURED VIA 2210968-2021-04742. CITATION CITE: EUR SURG (2021) 53:60¿65 HTTPS://DOI.ORG/10.1007/S10353-020-00671-Y.

    Description of Event or Problem · 1

    TITLE: HYBRID APPROACH TO VENTRAL WALL HERNIA REPAIR: A SINGLE INSTITUTION COHORT STUDY. THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO EVALUATE SHORT- AND LONG-TERM OUTCOMES IN PATIENTS UNDERGOING HVR BETWEEN OCTOBER 2012 AND JUNE 2016. THE SURGICAL APPROACH WAS STANDARDISED FOR ALL INCLUDED PATIENTS. FIFTY-SIX PATIENTS UNDERWENT HVR WITH SURGERY PERFORMED BY FOUR SURGEONS. PATIENTS UNDERGOING REPAIR OF VENTRAL HYBRID HERNIA UTILIZED PHYSIOMESH (ETHICON).THE MEAN AGE WAS 48 YEARS WITH A MEAN BMI OF 32.8KG/M2. 71.4% HAD INCISIONAL HERNIAS AND 28.6% HAD PRIMARY HERNIAS. ALL HERNIA DEFECTS WERE IDENTIFIED LAPAROSCOPICALLY, WITH ADHESIOLYSIS CARRIED OUT IN SOME CASES. THEREAFTER, THE HERNIA SAC CONTENT WAS REDUCED INTO THE ABDOMINAL CAVITY AND THE SAC CONTENT WAS FREED OF ADHESIONS. UPON REDUCTION OF ALL HERNIAL CONTENTS INTO THE ABDOMINAL CAVITY, PNEUMOPERITONEUM WAS REDUCED TO 4MMHG TO ALLOW CAREFUL AND ACCURATE MEASUREMENT OF DEFECT SIZE. SUBSEQUENTLY, THE OPEN APPROACH WHEREBY AN INCISION IS MADE OVER THE HERNIA DEFECT, UTILISING THE PREVIOUS SCAR. THE INCISION MADE IS LARGE ENOUGH TO ALLOW ADEQUATE DISSECTION OF THE HERNIA SAC AND EXPOSURE OF THE FASCIAL BORDERS. THE SAC IS THEN EXCISED AND HERNIA EDGES ARE CLEARED. EXTRACORPOREAL TRANSFACIAL CLOSURE OF THE HERNIA DEFECT WAS PERFORMED USING EITHER LOOP PDS OR INTERRUPTED ETHIBOND (ETHICON). THIS WAS THEN FOLLOWED BY A RETURN TO LAPAROSCOPY, WHERE THE CLOSURE WAS RE-ASSESSED. AT THAT TIME, THE MESH WAS APPROPRIATELY SIZED AND PREPARED FOR INSERTION WITH 2/0 PROLENE(ETHICON) TO ALLOW THE MESH TO BE LIFTED UP WITH A PARACHUTE TECHNIQUE TO ENSURE THAT THE COLLAGEN SIDE IS AGAINST THE ABDOMINAL CAVITY. THE MESH WAS SECURED ON THE ANTERIOR ABDOMINAL WALL USING A DOUBLE CROWN CONFIGURATION TECHNIQUE WITH MULTIPLE 5-MM TITANIUM SPIRAL TACKS (PROTACK; COVIDIEN, MA) OR SECURESTRAP (ETHICON SECURESTRAP¿) PLACEMENT ALONG IT BORDERS EVERY 2 TO 3CM. REPORTED COMPLICATIONS INCLUDED ADHESIONS, CHRONIC PAIN (N=2) REQUIRED POSTOPERATIVE INTRAVENOUS PATIENT-CONTROLLED ANALGESIA, HERNIA RECURRENCE(N=2),WOUND SEROMA (N=9), SURGICAL SITE INFECTION (N=2),URINARY RETENTION, ILEUS (N=1), RESPIRATORY COMPLICATION (N=2), READMISSION(N=1) WAS DUE TO POSTOPERATIVE HAEMATOMA AT DAY 10. THIS WAS MANAGED CONSERVATIVELY AND THE PATIENT DISCHARGED WITHIN 1 DAY. IN CONCLUSION THE HYBRID TECHNIQUE IS SAFE AND FEASIBLE, AND HAS IMPORTANT BENEFITS INCLUDING LOW RATES OF SEROMA FORMATION, CHRONIC PAIN AND HERNIA RECURRENCE. FUTURE INVESTIGATIONS MAY INCLUDE RANDOMISED CONTROLLED TRIALS TO EVALUATE THE BENEFITS OF VHR, WITH CAREFUL ASSESSMENT OF PATIENT-REPORTED OUTCOME MEASURES INCLUDING QUALITY OF LIFE AND POSTOPERATIVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739430 SECURESTRAP UNKNOWN PRODUCT IMPLANTABLE STAPLE GDW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention