BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-STRIPS DRY STAPLE LINE REINFORCEMENT

    MDR report key: 1654703 · Received April 5, 2010

    Report

    Report Number
    2183620-2010-00015
    Event Type
    Injury
    Date Received
    April 5, 2010
    Date of Event
    January 1, 2004
    Report Date
    March 8, 2010
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXZ
    PMA / PMN Number
    K040415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. JOURNAL ARTICLE: CONSTEN, ECJ, DAKIN, GF, GAGNE, M. CASE REPORT: INTRALUMINAL MIGRATION OF BOVINE PERICARDIAL STRIPS USED TO REINFORCE THE GASTRIC STAPLE-LINE IN LAPAROSCOPIC BARIATRIC SURGERY. OBES SURG 2004 (14): 549-554.

    Description of Event or Problem · 1

    ACCORDING TO THE ATTACHED JOURNAL ARTICLE, A (B) (6) WOMAN, (B) (6), UNDERWENT BILIOPANCREATIC DIVERSION - DUODENAL SWITCH (BPS-DS) VIA LAPAROSCOPY, USING PERI-STRIPS DRY TO REINFORCE THE ENTIRE STAPLE LINE. FOUR-WEEKS POST-OP, PATIENT WAS READMITTED WITH PROGRESSIVE NON-BILIOUS VOMITING. EXAMINATION OF THE VOMITUS REVEALED FRAGMENTS OF PERI-STRIPS DRY AND STAPLES. UPPER GI SERIES AND ABDOMINAL CT SCANS SHOWED NO EVIDENCE OF ANASTOMOTIC LEAK, OBSTRUCTION OF INTRA-ABDOMINAL ABSCESS. PATIENT'S VOMITING RESOLVED WITHOUT SPECIFIC INTERVENTION AND SHE WAS DISCHARGED 48-HRS LATER. AT 1-MO AND 2-MO FOLLOW-UP VISITS, PATIENT HAD OCCASIONAL NAUSEA, BUT NO VOMITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-STRIPS DRY STAPLE LINE REINFORCEMENT STAPLE LINE BUTTRESS DXZ SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other