MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number 720163-01

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Incontinence (1928); No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  Injury  

Event Description

It was reported that during the advance xp case the physician was tensioning the sling and the arm of the sling snapped and came off.The body of the mesh was already sutured into place.The physician tensioned the opposite side of the mesh arm without any issues.There was no issues with the position of the mesh that the physician could see.There was not any visible issues to the patient.The mesh was left in place.The physician felt the mesh was in the correct place and correct tension was achieved.He tensioned under cysto.No complications to the patient to report.Additional information received indicated the mesh broke inside the body.The mesh arm tore between the outermost anchor and middle anchor.The center portion of the mesh and the mesh arms were left in the body.The patient was still leaking and did not improve or become worse after the procedure.

Event Description

It was reported that during the advance xp case the physician was tensioning the sling and the arm of the sling snapped and came off.The mesh broke inside the body.The mesh arm tore between the outermost anchor and middle anchor.The center portion of the mesh and the mesh arms were left in the body.The body of the mesh was already sutured into place.The physician tensioned the opposite side of the mesh arm without any issues.There were no issues with the position of the mesh that the physician could see.There were not any visible issues to the patient.The mesh was left in place.The physician felt the mesh was in the correct place and correct tension was achieved.He tensioned under cysto.No complications to the patient to report.The patient was still leaking and did not improve or become worse after the procedure.6 months following the sling implant, the patient experienced no improvement with a sling device as incontinence was still present after original implant.The cystoscope showed that the sling was not coaptating and it is suspected that the pop that was heard during implantation might have affected the device.An artificial urinary sphincter (aus) implant procedure was performed on (b)(6) 2020.The new aus was successfully implanted and fully functional when tested.Coaptation was verified with a cystoscope.The patient was expected to fully recover following the procedure.

Manufacturer Narrative

Corrected data.

• Brand Name: AMS ADVANCE XP SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 9582038
• MDR Text Key: 175418913
• Report Number: 2183959-2020-00027
• Device Sequence Number: 1
• Product Code: OTM
• UDI-Device Identifier: 00878953005560
• UDI-Public: 00878953005560
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2020
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0024482492
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 06/01/2020
• Supplement Dates FDA Received: 06/20/2020
• Patient Sequence Number: 1
• Patient Age: 66 YR