BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2103226 · Received May 25, 2011

    Report

    Report Number
    3005099803-2011-01853
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    'DESCRIBE EVENT OR PROBLEM' WAS UPDATED WITH ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH AN UPHOLD VAGINAL SUPPORT SYSTEM IN OCTOBER 2010 (EXACT DATE UNKNOWN) BY HER GYNECOLOGIST. SOMETIME IN (B)(6) 2011, THE PATIENT PRESENTED WITH VAGINAL PAIN AND DYSPAREUNIA, AND WAS REFERRED TO AN OBSTETRICS & GYNECOLOGY SPECIALIST. PER THE SPECIALIST, THE PATIENT IS HAVING MANY COMPLICATIONS FROM ANTICOAGULATION, AND BLED INTO HER PSOAS MUSCLE. SHE WAS REHOSPITALIZED AND THEN TRANSFERRED TO ANOTHER HOSPITAL. THE SPECIALIST OPINED THAT THE UPHOLD MESH IS TOO TIGHT, BUT NOTED THAT IT IS A FEW CENTIMETERS AWAY FROM THE CUFF ABSCESS. THE PATIENT HAD BILATERAL PULMONARY EMBOLI AND A VERTEBRAL ARTERY CLOT, AND WAS FULLY ANTICOAGULATED. THE SPECIALIST ALSO OPINED THAT THE PATIENT'S MULTIPLE ABSCESSES WITH BOWEL BACTERIA SUGGEST THAT THE COLON WAS ENTERED DURING SURGERY. THE PROBLEM WAS RECOGNIZED WHEN SHE PRESENTED AT SIX DAYS POSTOPERATIVELY. THE ABSCESSES WERE SUCCESSFULLY TREATED WITH INTERVENTIONAL RADIOLOGY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT'S ABSCESSES WERE NOTED (B)(6) AFTER THE UPHOLD IMPLANTATION PROCEDURE, AND THE BILATERAL PULMONARY EMBOLI AND VERTEBRAL ARTERY CLOT OCCURRED APPROXIMATELY (B)(6) AFTER THE PROCEDURE. REPORTEDLY, NEITHER THE IMPLANTING PHYSICIAN NOR THE CONSULTING OBSTETRICS AND GYNECOLOGY SPECIALIST BELIEVE THE UPHOLD PLACEMENT PROCEDURE HAD ANY RELATION TO THE EMBOLI OR CLOT. THE IMPLANTING PHYSICIAN ALSO STATED HE DOESN'T THINK ANY OF THE PATIENT'S POST-OPERATIVE CONDITIONS HAD ANYTHING TO DO WITH THE MESH ITSELF, EITHER. THE EMBOLI ARE ATTRIBUTED BY THE IMPLANTING PHYSICIAN TO A PREVIOUSLY UNDIAGNOSED CLOTTING DISORDER. THE SPECIALIST STATED, "I DON'T THINK ANYONE CAN ATTRIBUTE THE CAUSE OF THE MULTIPLE SYSTEM CLOTS BUT CERTAINLY [THE PATIENT] HAD SOME ABSCESSES AND BEING SICK WOULD PUT HER AT RISK FOR THAT."

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT'S EMBOLI WERE "ADEQUATELY TREATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R