BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 18378943 · Received December 21, 2023

    Report

    Report Number
    1219930-2023-05325
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    July 28, 2023
    Report Date
    December 21, 2023
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE EVENTS: AUTHOR: LEANDRO SIRAGUSA/ VALERIA USAI/ BRUNELLA M. PIROZZI/ SIRVJO DHIMOLEA/MARZIA FRANCESCH TITLE: EARLY GASTRIC OUTLET OBSTRUCTION CAUSED BY THE FREE END OF BARBED SUTURES FOLLOWING LAPAROSCOPIC GASTRIC RESECTION WITH ROUX-EN-Y RECONSTRUCTION: LEANDRO SIRAGUSA, 2023, SMALL BOWEL OBSTRUCTION DUE TO BARBED SUTURE © AM J CASE REP, 2023; 24: E940661 SOURCE: DOI: 10.12659/AJCR.940661 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A 77-YEAR-OLD MALE UNDERWENT SUBTOTAL GASTRECTOMY FOLLOWED BY ROUX-EN-Y RECONSTRUCTION. THE COMMON ENTE ROTOMIES WERE SUTURED USING V-LOC. THE PATIENT WAS READMITTED 4 DAYS AFTER DISCHARGE AND AN UNEVENTFUL POST-OPERATIVE COURSE FOR VOMITING, NAUSEA, AND FATIGUE. THE PATIENT REQUIRED A NASOGASTRIC TUBE AND A COMPUTED TOMOGRAPHY SCAN. A DIAGNOSIS OF SMALL BOWEL OBSTRUCTION WAS MADE. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROSCOPY WHICH REVEALED THAT THE JEJUNUM, A COUPLE OF CENTIMETERS FROM THE ANASTOMOSIS WAS PINNED AND ANCHORED BY THE TAIL OF THE V-LOC CAUSING THE OBSTRUCTION. THE SUTURE WAS DIVIDED AND TRIMMED OFF. IN THIS CASE, THE TAIL OF THE SUTURE HAD BEEN LEFT LONG AND UNBURIED, BUT FOLLOWING THE LAPAROSCOPIC DIVISION OF THE ANCHORING SUTURE, THE BOWEL REGAINED ITS NORMAL CALIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305122 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization| R