BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-STRIPS DRY W/ VERITAS COLLAGEN MATRIX

    MDR report key: 1970493 · Received January 20, 2011

    Report

    Report Number
    2183620-2011-00009
    Event Type
    Injury
    Date Received
    January 20, 2011
    Report Date
    December 22, 2010
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K041669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    THE PT UNDERWENT AN UNEVENTFUL GASTRIC BYPASS PROCEDURE WITH PERI-STRIPS DRY W/ VERITAS COLLAGEN MATRIX STAPLE LINE REINFORCEMENT OF AN ECHELON 60 STAPLE LINE ON AN UNSPECIFIED DATE. APPROX 3-4 DAYS POST PROCEDURE, THE PT BECAME TACHYCARDIC AND EXHIBITED SYMPTOMS CONSISTENT WITH A GASTRIC LEAK. THE PT WAS TAKEN BACK TO THE OPERATING ROOM AT WHICH TIME IT WAS NOTED THAT A 1 CM HOLE, CONSISTENT WITH AN ULCER, WAS PRESENT ON THE GASTRIC POUCH LOCATED JUST OFF OF THE STAPLE LINE. THE GASTRIC HOLE WAS REPAIRED USING SUTURE AND A DRAIN WAS PLACED. THE DRAIN DID NOT PRODUCE MUCH OUTPUT UNTIL APPROX 1 WEEK POST PLACEMENT AT WHICH TIME THE PHYSICIAN NOTED A "SPONTANEOUS INCREASE IN DRAIN OUTPUT." THE PHYSICIAN TOOK THE PT BACK TO THE OPERATING ROOM AT WHICH TIME A SECOND 1CM HOLE, RESEMBLING AN ULCER, WAS NOTED - THIS TIME ON THE GASTRIC REMNANT. THE STAPLE LINE WAS REMOVED AND REPAIRED WITH SUTURE. THE REMOVED STAPLE LINE WAS SENT TO PATHOLOGY FOR ANALYSIS. A GASTRIC TUBE WAS PLACED IN THE GASTRIC REMNANT. A COUPLE OF DAYS LATER, THE PT EXHIBITED ADDITIONAL SYMPTOMS AND RETURNED TO THE OPERATING ROOM FOR A THIRD TIME. ANOTHER GASTRIC HOLE WAS NOTED ON THE GASTRIC POUCH AND A POSSIBLE FISTULA WAS FORMING. THE AREA WAS REPAIRED WITH SUTURE. PATHOLOGICAL ANALYSIS OF THE STAPLE LINE NOTED NO EOSINOPHILS, NOR ANY EVIDENCE OF A CHRONIC INFECTION OR ALLERGIC REACTION. AT THIS TIME, THE CAUSE OF THE GASTRIC HOLES (ULCERS) REMAINS UNK. THE PT REMAINS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-STRIPS DRY W/ VERITAS COLLAGEN MATRIX STAPLE LINE BUTTRESS FTM SYNOVIS SURGICAL INNOVATIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R