BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7384946 · Received March 30, 2018

    Report

    Report Number
    2210968-2018-71796
    Event Type
    Injury
    Date Received
    March 30, 2018
    Report Date
    March 8, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE ANY OF THE POST-OPERATIVE ISSUES MENTIONED IN THIS ARTICLE ARE FROM AN ALLEGED DEFICIENCY OF AN ETHICON DEVICE? NO ADDITIONAL INFORMATION RECEIVED THAT INDICATES THIS EVENT DOES NOT MEET REPORTING SERIOUS INJURY CRITERIA. THIS EVENT THEREFORE IS NOT REPORTABLE.

    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY DEFICIENCY OF THE ETHICON PRODUCT VICRYL SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CITATION: OBES SURG (2017) 27:432¿438; DOI 10.1007/S11695-016-2336-4; PUBLISHED ONLINE: 25 AUGUST 2016.

    Description of Event or Problem · 1

    TITLE: SINGLE ANASTOMOSIS GASTRIC BYPASS¿COMPARATIVE SHORT-TERM OUTCOME STUDY OF CONVERSIONAL AND PRIMARY PROCEDURES. IT WAS REPORTED IN A JOURNAL ARTICLE: THE AIM OF THIS COMPARATIVE SHORT-TERM OUTCOME STUDY WAS TO REVIEW AND ANALYZE SINGLE ANASTOMOSIS GASTRIC BYPASS (SAGB) PROCEDURES INCLUDING CONVERSIONAL SAGB (CSAGB) AND PRIMARY (PSAGB). THERE WERE 154 CONSECUTIVE SAGB PROCEDURES, INCLUDING 48 CSAGB AND 106 PSAGB. MALE AND FEMALE PATIENTS AGES 19 TO 76 WERE INCLUDED IN THE STUDY BETWEEN JUNE 2015 AND FEBRUARY 2016. FOUR LAPAROSCOPIC PORTS WERE USED. A LONG AND NARROW GASTRIC POUCH WAS FASHIONED ALONGSIDE THE LESSER CURVATURE BEGINNING AT THE INCISURA ANGULARIS WITH LINEAR STAPLERS (ECHELON 60 ENDOPATH STAPLER®, ETHICON ENDOSURGERY, (B)(4)). A GASTROJEJUNAL ANASTOMOSIS TO THIS POUCH WAS CREATED, AGAIN WITH A LINEAR STAPLER, FIRED AT 4.5 CM WITH HAND-SEWN, SINGLELAYER CONTINUOUS 2/0 POLYGLACTIN BRAIDED SUTURE (VICRYL®, ETHICON ENDOSURGERY, (B)(4)). THE ANASTOMOSIS WAS TESTED FOR LEAKAGE WITH BLUE DYE. WHEN FOUND, HIATAL HERNIAS WERE REPAIRED WITH ANTERIOR, NON-ABSORBABLE SUTURE CLOSURE. IN THE PSAGB GROUP, 6 PATIENTS HAD PERIOPERATIVE COMPLICATIONS. THESE INCLUDED ANASTOMOTIC LEAK AND SEPTIC SHOCK (N=1) WHO UNDERWENT AN URGENT LAPAROSCOPIC CONVERSION. FOLLOWING THE CONVERSION, DUE TO ANOTHER LEAK ORIGINATING FROM THE JEJUNOJEJUNAL ANASTOMOSIS, THE PATIENT WAS TAKEN AGAIN TO THE OPERATING ROOM WITH AN ATTEMPTED CLOSURE OF THE LEAK. AS THE REPAIR FAILED, THE PATIENT WAS TREATED WITH A LAPAROTOMY AND DIVERSION. ANASTOMOTIC STENOSIS AND DYSPHAGIA (N=2), DIAGNOSED BY FLUOROSCOPY AND NECESSITATED CONVERSION, BLEEDING MARGINAL ULCER (N=2), 1 TREATED BY PPI ALONE AND THE OTHER BY ENDOSCOPIC HEMOSTASIS, MILD INTRA-ABDOMINAL BLEEDING (N=1) DEMONSTRATED BY BLOODY DISCHARGE IN HIS DRAIN AND A REDUCTION IN HEMOGLOBIN, BUT DID NOT REQUIRE ANY INTERVENTION. IN CONCLUSION, SAGB MAY BE CONSIDERED AS A SAFE AND EFFECTIVE CONVERSIONAL PROCEDURE, BUT NOT AS EFFECTIVE AS PSAGB FOR INITIAL WEIGHT LOSS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227869 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention