BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 12225601 · Received July 26, 2021

    Report

    Report Number
    2210968-2021-06666
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    May 3, 2021
    Report Date
    July 13, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE NOT RETURNED. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE AND MONOCRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE (MARGINAL ULCERS, BLEEDING AND PERFORATION OF THE GASTROJEJUNAL ANASTOMOTIC) ? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE AND MONOCRYL SUTURE) USED IN THIS PROCEDURE/STUDY? PLEASE SPECIFY. IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS ((MARGINAL ULCERS, BLEEDING AND PERFORATION OF THE GASTROJEJUNAL ANASTOMOTIC)? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION:OBESITY SURGERY (2021) 31:2921¿2926 HTTPS://DOI.ORG/10.1007/S11695-021-05292-2. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENTS WERE SUBMITTED VIA 2210968-2021-06665.

    Description of Event or Problem · 1

    TITLE: IMPACTS OF GASTROJEJUNAL ANASTOMOTIC TECHNIQUE ON RATES OF MARGINAL ULCER FORMATION AND ANASTOMOTIC BLEEDING FOLLOWING ROUX-EN-Y GASTRIC BYPASS THE OBJECTIVES OF THIS STUDY WAS TO ANALYZE THE INCIDENCE OF MU AND BLEEDING BETWEEN THE 25-MM END-TO-END ANASTOMOSIS (EEA) STAPLER, LINEAR STAPLER (LS), AND ROBOTIC HAND-SEWN (RHS) GJA TECHNIQUES. A TOTAL OF 1112 PATIENTS UNDERWENT ROUX-EN-Y GASTRIC BYPASS BETWEEN 2010 AND 2014. OF THESE PATIENTS, 652 (58.6%) HAD A GJA PERFORMED VIA AN EEA CIRCULAR STAPLER,374 (33.6%) HAD A GJA PERFORMED VIA A LINEAR STAPLED APPROACH, AND 86 (7.7%) HAD A GJA PERFORMED WITH A ROBOTIC HAND-SEWN APPROACH. OUT OF ALL PATIENTS, 194/1,112 (17.4%) UNDERWENT AN UPPER ENDOSCOPY. END-TO-END ANASTOMOSIS (EEA) A 25-MM EEA STAPLER WAS USED TO CREATE THE GJA, AND ONE OF THE TWO METHODS FOR INTRODUCING THE ANVIL WAS EMPLOYED: INTRODUCTION VIA A SEPARATE MGASTROTOMY PRIOR TO CREATING THE POUCH OR INTRODUCTION USING AN OROGASTRIC TUBE. THE STAPLER WAS INTRODUCED VIA AN ENTEROTOMY IN THE ROUX LIMB, WITH THE SPIKE DEPLOYED THROUGH THE SIDEWALL OF THE ROUX LIMB SMALL BOWEL AND SUBSEQUENTLY JOINED WITH THE ANVIL IN THE GASTRIC POUCH (THE GASTRIC POUCH REMAINED APPROXIMATELY 30CC IN SIZE). THE ROUX-LIMB OVERHANG WAS THEN REMOVED USING AN ECHELON 60-MM BLUE LINEAR STAPLE LOAD(ETHICON) SUCH THAT THE TIP OF THE ROUX LIMB WAS POINTING TOWARD THE RIGHT SIDE OF THE PATIENT. LINEAR STAPLER (LS) AN ECHELON 45-MM STAPLER BLUE LOAD (ETHICON) WAS USED TO CREATE THE GJA WITH THE STAPLE LINE MEASURING APPROXIMATELY 2.5CM, AND THE COMMON GASTROTOMY/ENTEROTOMY WAS CLOSED USING A 2-0 VICRYL SUTURE(ETHICON). THE ROUX-LIMB OVERHANG WAS THEN REMOVED USING AN ECHELON 60-MM BLUE LINEAR STAPLE LOAD SUCH THAT THE TIP OF THE ROUX LIMB WAS POINTING TOWARD THE LEFT SIDE OF THE PATIENT. ROBOTIC HAND SEWN (RHS) A 30-CC GASTRIC POUCH WAS CREATED USING A LINEAR STAPLER AND A GASTROTOMY AND ENTEROTOMY MADE. A TWO-LAYERED HAND-SEWN GJA WAS THEN CREATED USING 2-0 VICRYL SUTURES(ETHICON) FOR THE ANTERIOR/POSTERIOR OUTER LAYERS AND A RUNNING 3-0 MONOCRYL SUTURE(ETHICON) FOR THE INNER LAYERS. REPORTED COMPLICATIONS INCLUDED MARGINAL ULCERS, BLEEDING, PERFORATION OF THE GASTROJEJUNAL ANASTOMOTIC. IN CONCLUSION THE METHOD OF GJA HAS AN IMPACT ON RATE OF MU FORMATION. A GJA FASHIONED WITH A 25-MM EEA STAPLER TENDS TO HAVE HIGHER RATES OF EGD AND MU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120993 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention