BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9841549 · Received March 17, 2020

    Report

    Report Number
    2210968-2020-02135
    Event Type
    Injury
    Date Received
    March 17, 2020
    Report Date
    February 20, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. 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 (VICRYL SUTURE) 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 (VICRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. CITATION: ABCD ARQ BRAS CIR DIG. (2019); 32(3):E1452. DOI: /10.1590/0102-672020190001E1452. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: ROUTINE USE OF V-LOCK® SUTURE FOR BARIATRIC ANASTOMOSIS IS SAFE: COMPARATIVE RESULTS FROM CONSECUTIVE CASE SERIES" AUTHORS: CLAUDIA BURES, PHILIPPA SEIKA, CHRISTIAN DENECKE, JOHANN PRATSCHKE, RICARDO ZORRON CITATION: ABCD ARQ BRAS CIR DIG. (2019); 32(3):E1452. DOI: /10.1590/0102-672020190001E1452. THE AIM OF THIS STUDY WAS TO DESCRIBE THE RESULTS OF THE INSTITUTIONAL EXPERIENCE IN A COMPARATIVE EVALUATION OF BOTH SUTURING METHODS IN HAND-SEWN GASTROJEJUNOSTOMY (GJ) AND JEJUNOJEJUNOSTOMY (JJ) DURING BARIATRIC SURGERY. THIS PROSPECTIVE STUDY INVOLVES 87 MORBIDLY OBESE PATIENTS (21 MALE AND 66 FEMALE; AVERAGE AGE: 44.630±11.78 YEARS; AVERAGE BMI: 47.089±6.95) WHO UNDERWENT LAPAROSCOPIC GASTRIC-BYPASSES USING A HAND-SEWN TECHNIQUE TO PERFORM THE GASTRO-JEJUNAL ANASTOMOSIS (GJA) AND JEJUNOJENUNAL ANASTOMOSIS (JJA) ) BETWEEN JANUARY 2015 AND JUNE 2017. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: IN GROUP I, 45 PATIENTS (11 MALE AND 34 FEMALE; AGE: 43.74 ±10.918 YEARS; BMI: 47.711 ± 6.63 KG/M2) USED A UNIDIRECTIONAL ABSORBABLE BARBED SUTURE FOR ANASTOMOSIS; IN GROUP II, 42 PATIENTS (10 MALE AND 32 FEMALE; AGE: 45.45 ±12.609 YEARS; BMI: 46.421 ±7.28 KG/M2) USED AN ABSORBABLE SUTURE (VICRYL 3/0; ETHICON) MAKING AN INTRACORPOREAL KNOT FOR ANASTOMOSIS. IN GROUP II, THE ENTEROTOMY WAS CLOSED WITH A RESORBABLE POLYFILAMENT SUTURE (VICRYL 3/0; ETHICON). ALSO, THE GASTROJEJUNAL ANASTOMOSIS WAS CLOSED USING RESORBABLE POLYFILAMENT SUTURE (VICRYL 3.0; ETHICON). REPORTED COMPLICATION IN GROUP II INCLUDED STENOSIS FROM GJA (N-1) IN WHICH THE PATIENT REQUIRED REOPERATION. DUE TO ITS SAFETY PROFILE AND EASE OF MANAGEMENT, THIS KIND OF SUTURE CAN BE INCLUDED IN THE STANDARD SURGICAL BARIATRIC TECHNIQUE AND CAN HELP ATTENDING SURGEONS TO TRAIN RESIDENTS IN THE DIFFICULT TASK OF GASTROINTESTINAL ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304766 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention