BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7379724 · Received March 28, 2018

    Report

    Report Number
    2210968-2018-71731
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    March 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 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 PRODUCTS USED IN THIS PROCEDURE? CITATION: OBES SURG (2017) 27:2927¿2932; DOI 10.1007/S11695-017-2731-5.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: SLEEVE GASTRECTOMY POSTOPERATIVE HEMORRHAGE IS LINKED TO TYPE-2 DIABETES AND NOT TO SURGICAL TECHNIQUE" AUTHOR(S): HADAR SPIVAK, CARMIL AZRAN, GALIA SPECTRE, GALINA LIDERMANN, ORIT BLUMENFELD ¿ CITATION: OBES SURG (2017) 27:2927¿2932; DOI 10.1007/S11695-017-2731-5. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO REPORT THE PREVALENCE, SEVERITY, AND RISK FACTORS OF LAPAROSCOPIC SLEEVE GASTRECTOMY POSTOPERATIVE HAEMORRHAGE (ACUTE AND SUBCLINICAL) IN A COHORT WITH STANDARD SETTINGS. FROM 01JAN2014 TO 31DEC2015, 394 PATIENTS UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY AND WERE ASSIGNED INTO THREE SURGICAL TECHNIQUES: GROUP A (N=137) UNDERWENT CONVENTIONAL ORDER OF STAPLING STARTING TO WHERE ECHELON FLEX BLACK CARTRIDGE OR IDRIVE ULTRA PURPLE CARTRIDGE WAS USED AND ENDING WITH BLUE OR BEIGE, GROUP B (N=145) UNDERWENT TIGHT STAPLING WITH SMALLER CLOSING STAPLE HEIGHT RELOAD (WHITE ECHELON FLEX RELOAD OR BEIGE IDRIVE ULTRA), AND GROUP C (N=115) UNDERWENT OVERSUTURING THE STAPLE LINE WITH 2¿0 VICRYL IN A CONTINUOUS BASEBALL FASHION OVER A CONVENTIONAL ORDER OF RELOADS. POSTOPERATIVE COMPLICATIONS INCLUDED 2 PATIENTS HAD LEAKS (GROUP A AND GROUP C) WHICH WERE TREATED BY SURGICAL RE-EXPLORATION AND DRAINAGE, FOLLOWED BY TPN; 2 PATIENTS HAD SLEEVE KINK AND PARTIAL OBSTRUCTION (GROUP A AND GROUP B) TREATED WITH ROUX-EN-Y GASTRIC BYPASS (N=1) AND MONTHS OF LIQUID-ONLY INTAKE (N=1); ONE PATIENT HAD ABDOMINAL WALL ADHESION (GROUP B) CAUSING UNSOLVED SEVERE PAIN WHICH WAS TREATED WITH LAPAROSCOPIC EXPLORATION; ONE PATIENT HAD PELVIC ABSCESS (GROUP A) TREATED WITH DRAINAGE; TWO PATIENTS HAD WOUND INFECTIONS (GROUP A AND GROUP B) REQUIRING BEDSIDE DRAINAGE; AND ONE PATIENT WAS DIAGNOSED WITH CLOSTRIDIUM DIFFICILE INFECTION (GROUP C). SINCE PATIENTS WITH DIABETES HAVE IMPAIRED WOUND HEALING, A DEFECTIVE STAPLE LINE HEALING, TISSUE MATURING, AND THUS FRAIL SEALING OF EMBEDDED VESSELS COULD BE THE REASON FOR EXCESSIVE POSTOPERATIVE HAEMORRHAGE IN TYPE 2 DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219835 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention