BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX STAPLE LINE REINFORCEMENT

    MDR report key: 3028291 · Received April 1, 2013

    Report

    Report Number
    2032282-2013-00033
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K041669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: A CT SCAN WAS PERFORMED THREE WEEKS AFTER A GASTRIC BYPASS BECAUSE OF PERSISTENT ABDOMINAL PAIN WHICH REVEALED A 'LIT UP' STAPLE LINE. THERE IS NO SURGICAL OR PATHOLOGICAL CONFIRMATION OF THIS FINDING, OR A CLINICAL CONFIRMATION THAT THE ABDOMINAL PAIN CAN BE CORRELATED TO THE RADIOLOGICAL FINDINGS. FOLLOW-UP REGARDING THE OUTCOME OF THE ABDOMINAL PAIN AND FURTHER THERAPEUTIC MEASURES ARE REQUIRED. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE REPORTER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IN 2032282-2013-00033 SUB 1 WE STATED THAT "PER SYNOVIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE ULCER." CORRECTED INFORMATION IS THAT "PER SYNOVIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE ABDOMINAL PAIN."

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE ADDITIONAL CASE INFORMATION. THE REPORTING SURGEON REPLIED ADVISED THAT HE DOES UNDERSTAND THE IMPORTANCE OF THIS FOLLOW-UP, HOWEVER TRYING TO LOOK BACK OVER 3 YEARS AND GET THAT INFORMATION IS PROVING TOO TIME CONSUMING FOR ME AT THIS TIME IN MY PRACTICE. DUE TO THE LACK OF INFORMATION, A CAUSAL RELATIONSHIP CANNOT BE DETERMINED. BAXTER SYNOVIS COMPLETED THE INVESTIGATION. NO SAMPLE OR LOT NUMBER WAS PROVIDED THEREFORE THE SAMPLE EVALUATION AND BATCH REVIEW WERE NOT PERFORMED. PER SYNOVIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE ULCER. THE COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED TO BAXTER THAT HE HAD A PATIENT, WHO HAD A SLEEVE GASTRECTOMY GASTRIC BYPASS (THREE WEEKS POST-OPERATIVE), COMPLAINED OF ABDOMINAL PAIN. THE PATIENT WAS EVALUATED, WHICH INCLUDED CT SCAN, AND CUSTOMER WAS CONCERNED THAT THE RADIOLOGIST REPORT CALLED OUT THE GASTRIC STAPLE LINE AS 'LIT UP'. THE CUSTOMER STATED HE HAD NEVER HAD THE RADIOLOGIST STATE THIS OBSERVATION BEFORE AND HE WAS CONCERNED THAT IT MAY INDICATE AN INFLAMMATORY PROCESS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132565 PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX STAPLE LINE REINFORCEMENT MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other