BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 3480580 · Received November 21, 2013

    Report

    Report Number
    3005099803-2013-13907
    Event Type
    Injury
    Date Received
    November 21, 2013
    Date of Event
    October 11, 2013
    Report Date
    October 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PAH
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(6) 2013, THE SUBJECT WAS REPORTED TO BE RECOVERED.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED; THEREFORE A PHYSICAL EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE DIRECTIONS FOR USE (DFU). DEHISCENCE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE PROCEDURE AND IS LISTED IN THE DFU. THEREFORE, THIS EVENT IS CONSIDERED AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH SOLYX SINGLE INCISION SLING FOR STRESS URINARY INCONTINENCE ON (B)(6) 2013. AT THE PATIENT'S SIX-WEEK FOLLOW-UP VISIT ON (B)(6) 2013, THE PATIENT PRESENTED WITH A 15 MM MIDLINE MESH EXPOSURE AT THE INCISION SITE; IT APPEARED THAT THE STITCHES HAD BEEN TORN THROUGH. SURGICAL REPAIR WILL BE PERFORMED. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION (B)(6) 2013: ON (B)(6) 2013 (87 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT 80% SLING REMOVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH SOLYX SINGLE INCISION SLING FOR STRESS URINARY INCONTINENCE ON (B)(6) 2013. AT THE PATIENT'S SIX-WEEK FOLLOW-UP VISIT ON (B)(6) 2013, THE PATIENT PRESENTED WITH A 15 MM MIDLINE MESH EXPOSURE AT THE INCISION SITE; IT APPEARED THAT THE STITCHES HAD BEEN TORN THROUGH. SURGICAL REPAIR WILL BE PERFORMED. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH SOLYX SINGLE INCISION SLING FOR STRESS URINARY INCONTINENCE ON (B)(6) 2013. AT THE PATIENT'S SIX-WEEK FOLLOW-UP VISIT ON (B)(6) 2013, THE PATIENT PRESENTED WITH A 15 MM MIDLINE MESH EXPOSURE AT THE INCISION SITE; IT APPEARED THAT THE STITCHES HAD BEEN TORN THROUGH. SURGICAL REPAIR WILL BE PERFORMED. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH SOLYX SINGLE INCISION SLING FOR STRESS URINARY INCONTINENCE ON (B)(6) 2013. AT THE PATIENT'S SIX-WEEK FOLLOW-UP VISIT ON (B)(6) 2013, THE PATIENT PRESENTED WITH A 15 MM MIDLINE MESH EXPOSURE AT THE INCISION SITE; IT APPEARED THAT THE STITCHES HAD BEEN TORN THROUGH. SURGICAL REPAIR WILL BE PERFORMED. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION (B)(4) 2013: ON (B)(6) 2013 (87 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT 80% SLING REMOVAL. ADDITIONAL INFORMATION (B)(4) 2014: THE EXCISION PROCEDURE ON (B)(6) 2013, WAS PERFORMED BY A DIFFERENT PHYSICIAN FROM THE SAME PRACTICE AS THE IMPLANTATION SURGEON. TWO WEEKS PRIOR TO THE SLING EXCISION PROCEDURE, THIS SECOND PHYSICIAN PERFORMED SING REVISION IN AN ATTEMPT TO CORRECT A SMALL 1 CM EROSION OF THE SLING. HOWEVER, THE REPAIR BROKE DOWN AND THE PATIENT REQUESTED REMOVAL OF THE SLING. DURING THE REMOVAL PROCEDURE ON (B)(6) 2013, THE SLING EXPOSURE WAS OBSERVED TO BE 2.5 CM IN LENGTH. THE PHYSICIAN DISSECTED THE ADJACENT TISSUE TO EXPOSE APPROXIMATELY 5 CM OF SLING MATERIAL; THIS EXPOSED MESH WAS THEN EXCISED. CYSTOSCOPY WAS THEN PERFORMED, AND IT WAS FOUND THAT THE TRIGONE AND URETHRAL MUCOSA APPEARED NORMAL, AND EFFLUX OF INDIGO CARMINE FROM BOTH URETERAL ORIFICES INDICATED THERE WAS NO URETERAL OBSTRUCTION. THE SUBURETHRAL AND VAGINA MUCOSA WERE THEN SUTURED CLOSED AND A VAGINAL PACKING WITH PREMARIN CREAM WAS PLACED. THE PATIENT WAS THEN TAKEN TO RECOVERY ROOM IN GOOD CONDITION, AND DISCHARGED LATER THE SAME DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH SOLYX SINGLE INCISION SLING FOR STRESS URINARY INCONTINENCE ON (B)(6) 2013. AT THE PATIENT'S SIX-WEEK FOLLOW-UP VISIT ON (B)(6) 2013, THE PATIENT PRESENTED WITH A 15 MM MIDLINE MESH EXPOSURE AT THE INCISION SITE; IT APPEARED THAT THE STITCHES HAD BEEN TORN THROUGH. SURGICAL REPAIR WILL BE PERFORMED. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION (B)(4) 2013: ON (B)(6) 2013 (87 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT 80% SLING REMOVAL. ADDITIONAL INFORMATION (B)(4) 2014: THE EXCISION PROCEDURE ON (B)(6) 2013, WAS PERFORMED BY A DIFFERENT PHYSICIAN FROM THE SAME PRACTICE AS THE IMPLANTATION SURGEON. TWO WEEKS PRIOR TO THE SLING EXCISION PROCEDURE, THIS SECOND PHYSICIAN PERFORMED SING REVISION IN AN ATTEMPT TO CORRECT A SMALL 1 CM EROSION OF THE SLING. HOWEVER, THE REPAIR BROKE DOWN AND THE PATIENT REQUESTED REMOVAL OF THE SLING. DURING THE REMOVAL PROCEDURE ON (B)(6) 2013, THE SLING EXPOSURE WAS OBSERVED TO BE 2.5 CM IN LENGTH. THE PHYSICIAN DISSECTED THE ADJACENT TISSUE TO EXPOSE APPROXIMATELY 5 CM OF SLING MATERIAL; THIS EXPOSED MESH WAS THEN EXCISED. CYSTOSCOPY WAS THEN PERFORMED, AND IT WAS FOUND THAT THE TRIGONE AND URETHRAL MUCOSA APPEARED NORMAL, AND EFFLUX OF INDIGO CARMINE FROM BOTH URETERAL ORIFICES INDICATED THERE WAS NO URETERAL OBSTRUCTION. THE SUBURETHRAL AND VAGINA MUCOSA WERE THEN SUTURED CLOSED AND A VAGINAL PACKING WITH PREMARIN CREAM WAS PLACED. THE PATIENT WAS THEN TAKEN TO RECOVERY ROOM IN GOOD CONDITION, AND DISCHARGED LATER THE SAME DAY. ADDITIONAL INFORMATION RECEIVED (B)(4) 2014: AS OF (B)(6) 2013, THE SUBJECT WAS REPORTED TO BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605444 SOLYX SIS SYSTEM MESH, SURGICAL, SYNTHETIC PAH BOSTON SCIENTIFIC - MARLBOROUGH M0068507000 ML00001496

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention