BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2050688 · Received April 12, 2011

    Report

    Report Number
    3005099803-2011-01157
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    'AE OR PRODUCT PROBLEM' FIELD CORRECTED FROM 'ADVERSE EVENT' TO 'REPORTED ISSUE IS BOTH AN ADVERSE EVENT AND PROBLEM'.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A CYSTOCELE REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE PHYSICIAN SUCCESSFULLY PLACED A MESH LEG IN THE PATIENT'S RIGHT SACROSPINOUS LIGAMENT. WHEN THE PHYSICIAN THREW THE OTHER MESH LEG THROUGH THE LEFT SACROSPINOUS LIGAMENT, HE REALIZED HE DID NOT LIKE THE PLACEMENT AND PULLED IT BACK OUT. THE PHYSICIAN THREW THE MESH LEG AGAIN, DETERMINED THE PLACEMENT WAS FINE, AND FINISHED PLACING THE UPHOLD. THE PHYSICIAN THEN PLACED AN OBTRYX CURVED TRANSOBTURATOR SLING SYSTEM UNDER THE PATIENT'S URETHRA. HOWEVER, BEFORE HE WENT TO CLOSE THE PATIENT, HE NOTICED THERE WAS BLOOD IN HER URINE. THE PHYSICIAN OPINED THAT HE HAD CREATED A CYSTOTOMY BY INADVERTENTLY THROWING THE UPHOLD MESH LEG THROUGH THE BLADDER INSTEAD OF THROUGH THE SACROSPINOUS LIGAMENT. HE SAID HE MUST NOT HAVE CLEANED OFF THE SACROSPINOUS LIGAMENT WELL ENOUGH, CAUSING HIM TO MISPLACE THE MESH LEG. THE CYSTOTOMY WAS NOT REPAIRED, AS IT WAS EXPECTED TO HEAL ON ITS OWN. THE PHYSICIAN DECIDED TO REMOVE THE UPHOLD MESH FROM THE PATIENT, BECAUSE HE DIDN'T WANT THE MESH TO HEAL OVER THE CYSTOTOMY. AS HE WAS REMOVING THE UPHOLD, THE MESH OF THE LEFT LEG ASSEMBLY DETACHED FROM THE MESH BODY, INSIDE THE PATIENT. THE PHYSICIAN COULD NOT FIND THE DETACHED MESH TO RETRIEVE IT, ALTHOUGH HE ATTEMPTED TO LOCATE IT BY PALPATION AND BY PUTTING A RETRACTOR BETWEEN THE BLADDER AND VAGINAL MUCOSA TO VISUALIZE IT. THE REST OF THE UPHOLD MESH WAS REMOVED, AND THE PHYSICIAN DID AN ANTERIOR REPAIR INSTEAD, WHICH ALSO COVERED UP THE BLADDER DEFECT. HE LEFT THE OBTRYX SLING IN PLACE. THE PHYSICIAN PUT BLUE DYE IN THE BLADDER TO DETERMINE IF THE URETERS WERE WORKING, AND DISCOVERED THAT THE LEFT URETER WAS NON-FUNCTIONAL. THE PHYSICIAN THINKS THIS MAY BE ATTRIBUTABLE TO THE MESH LEG BEING PULLED THROUGH THE BLADDER. THE PATIENT WAS CLOSED, AND THE PHYSICIAN STATED THAT HE NEEDS TO LET THE PATIENT HEAL AND THEN GO BACK IN AND FIX THE URETER. THE PATIENT STAYED IN THE HOSPITAL OVERNIGHT AS PART OF THE NORMAL POST-OPERATIVE PROTOCOL. THE CURRENT CONDITION OF THE PATIENT'S LEFT URETER IS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN HAS NOT BROUGHT THE PATIENT BACK FOR ADDITIONAL SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A CYSTOCELE REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE PHYSICIAN SUCCESSFULLY PLACED A MESH LEG IN THE PATIENT'S RIGHT SACROSPINOUS LIGAMENT. WHEN THE PHYSICIAN THREW THE OTHER MESH LEG THROUGH THE LEFT SACROSPINOUS LIGAMENT, HE REALIZED HE DID NOT LIKE THE PLACEMENT AND PULLED IT BACK OUT. THE PHYSICIAN THREW THE MESH LEG AGAIN, DETERMINED THE PLACEMENT WAS FINE, AND FINISHED PLACING THE UPHOLD. THE PHYSICIAN THEN PLACED AN OBTRYX CURVED TRANSOBTURATOR SLING SYSTEM UNDER THE PATIENT'S URETHRA. HOWEVER, BEFORE HE WENT TO CLOSE THE PATIENT, HE NOTICED THERE WAS BLOOD IN HER URINE. THE PHYSICIAN OPINED THAT HE HAD CREATED A CYSTOTOMY BY INADVERTENTLY THROWING THE UPHOLD MESH LEG THROUGH THE BLADDER INSTEAD OF THROUGH THE SACROSPINOUS LIGAMENT. HE SAID HE MUST NOT HAVE CLEANED OFF THE SACROSPINOUS LIGAMENT WELL ENOUGH, CAUSING HIM TO MISPLACE THE MESH LEG. THE CYSTOTOMY WAS NOT REPAIRED, AS IT WAS EXPECTED TO HEAL ON ITS OWN. THE PHYSICIAN DECIDED TO REMOVE THE UPHOLD MESH FROM THE PATIENT, BECAUSE HE DIDN'T WANT THE MESH TO HEAL OVER THE CYSTOTOMY. AS HE WAS REMOVING THE UPHOLD, THE MESH OF THE LEFT LEG ASSEMBLY DETACHED FROM THE MESH BODY, INSIDE THE PATIENT. THE PHYSICIAN COULD NOT FIND THE DETACHED MESH TO RETRIEVE IT, ALTHOUGH HE ATTEMPTED TO LOCATE IT BY PALPATION AND BY PUTTING A RETRACTOR BETWEEN THE BLADDER AND VAGINAL MUCOSA TO VISUALIZE IT. THE REST OF THE UPHOLD MESH WAS REMOVED, AND THE PHYSICIAN DID AN ANTERIOR REPAIR INSTEAD, WHICH ALSO COVERED UP THE BLADDER DEFECT. HE LEFT THE OBTRYX SLING IN PLACE. THE PHYSICIAN PUT BLUE DYE IN THE BLADDER TO DETERMINE IF THE URETERS WERE WORKING, AND DISCOVERED THAT THE LEFT URETER WAS NON-FUNCTIONAL. THE PHYSICIAN THINKS THIS MAY BE ATTRIBUTABLE TO THE MESH LEG BEING PULLED THROUGH THE BLADDER. THE PATIENT WAS CLOSED, AND THE PHYSICIAN STATED THAT HE NEEDS TO LET THE PATIENT HEAL AND THEN GO BACK IN AND FIX THE URETER. THE PATIENT STAYED IN THE HOSPITAL OVERNIGHT AS PART OF THE NORMAL POST-OPERATIVE PROTOCOL. THE CURRENT CONDITION OF THE PATIENT'S LEFT URETER IS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN HAS NOT BROUGHT THE PATIENT BACK FOR ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML1020301

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention OBTRYX CURVED TRANSOBTURATOR SLING SYSTEM