BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19097757 · Received April 12, 2024

    Report

    Report Number
    2210968-2024-04238
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    January 1, 2023
    Report Date
    April 12, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CITATION: DISEASES OF THE COLON AND RECTUM. 2023. 66:313.

    Description of Event or Problem · 0

    TITLE: DACRON VASCULAR GRAFT PROSTHESIS FOR THE MANAGEMENT OF A BLOWHOLE COLOSTOMY. THIS STUDY REPORTS A CASE OF A 74-YEAR-OLD MALE WITH A HISTORY NOTABLE FOR METASTATIC CARCINOID WHO PRESENTED WITH A SIGMOID COLON OBSTRUCTION SECONDARY TO DISEASE BURDEN. HE HAD BEEN TREATED PREVIOUSLY WITH PRRT, RADIATION THERAPY, AND TUMOR REMOVAL VIA OPEN SMALL BOWEL RESECTION 14 YEARS PRIOR. ADDITIONAL SURGICAL HISTORY INCLUDED A SUBSEQUENT LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH, AS WELL AS PRIOR OPEN INGUINAL HERNIA REPAIR WITH MESH, LAPAROSCOPIC CHOLECYSTECTOMY, AND OPEN APPENDECTOMY. ENDOSCOPIC STENT PLACEMENT FOR HIS OBSTRUCTION WAS ATTEMPTED, BUT UNSUCCESSFUL AS IT WAS UNABLE TO BE TRAVERSED WITH A WIRE. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM FOR EXPLORATORY LAPAROTOMY WITH PLAN TO CREATE A DIVERTING LOOP COLOSTOMY. INTRAOPERATIVELY, THE PATIENT WAS NOTED TO HAVE A FROZEN ABDOMEN WHICH MADE IT DIFFICULT TO EVEN IDENTIFY THE ANTERIOR WALL OF A DILATED TRANSVERSE COLON. THEREFORE, A TRANSVERSE BLOWHOLE COLOSTOMY WAS BROUGHT OUT JUST LATERAL TO THE INCISION. EIGHT MONTHS AFTER THE PROCEDURE, THE PATIENT HAD ONGOING PROBLEMS WITH POUCHING AND SEVERE PAIN FROM PERI-STOMAL SKIN IRRITATION. THE PATIENT UNDERWENT PLACEMENT OF A 24 MM DACRON GRAFT IN THE OPERATING ROOM UNDER MONITORED SEDATION. THE GRAFT WAS CUT TO 3 CM IN LENGTH AND ATTACHED TO THE MUCOCUTANEOUS JUNCTION USING A RUNNING 4-0 VICRYL (ABSORBABLE) SUTURE. REPORTED COMPLICATIONS INCLUDE THE STITCHES PULLED AWAY FROM THE INFERIOR ASPECT OF THE GRAFT CAUSING LEAKAGE AT TWO WEEKS POSTOPERATIVELY. THE GRAFT WAS RE-SUTURED UNDER LOCAL ANESTHESIA, THIS TIME WITH 4-0 NYLON (NON-ABSORBABLE) SUTURE USING INTERRUPTED HORIZONTAL MATTRESSES. THIS WAS REPEATED TWO MORE TIMES IN THE OUTPATIENT SETTING AND ONE FINAL TIME IN THE OPERATING ROOM, WHERE LARGE BITES OF SKIN COULD BE TAKEN WITH NON-ABSORBABLE SUTURE TO SECURE THE GRAFT. IN CONCLUSION, THE AUTHORS PRESENT A CASE OF IMPROVED POUCHING AND QUALITY OF LIFE AFTER CREATION OF A DACRON GRAFT SILO FOR MANAGEMENT OF A DIFFICULT COLOSTOMY. IN CONTRAST TO THE ORIGINAL CASE SERIES, THE AUTHORS FOUND IMPROVED GRAFT FUNCTION WITH: (1) USE OF NON-ABSORBABLE SUTURE (2) USE OF INTERRUPTED MATTRESS SUTURE RATHER THAN RUNNING (3) GRAFT CUT TO 3-4CM RATHER THAN 5 AND (4) LARGER BITES OF SKIN AT THE MUCOCUTANEOUS JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470121 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention