MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the physician set out to implant an altis and do a plication posterior prolapse repair and suspension to sacrospinous ligament (concomitant with altis but nothing coloplast used for this prolapse procedure.) altis was implanted and then the physician cysto'd.While cystoing she noticed fluid coming from somewhere other than meatus.Upon further inspection the physician recognized the old fistula had created a lateral opening off the urethra.At this time the territory manager cited implanting altis with fistula is contraindicated.The physician acknowledged she knew that, said the fistula opening was lateral & distal to where the altis was being implanted.She proceeded to stitch up the fistula opening, took a graft of anterior vaginal wall and stitched that over the fistula opening repair, and implanted altis.While tensioning altis, she ran out of adjustment suture length and when she tried to force the adjustment suture, not knowing the dynamic anchor was right up against the mesh, the suture broke.I advised the best option was to explant this altis and implant another one.Physician shared she had stitched her fistula opening repair around the static side mesh and so she didn't want to explant that mesh or try to re-anchor another altis on that static side, so she said she decided to anchor a polyprolene suture into the dynamic side obturator internus then threaded both ends of that suture through the dynamic side of the mesh and tie it down.She tried several different positions on the mesh this way before she felt when tied down the mesh was laying and under tension the way she customarily likes to see altis lay under the urethra.Once she found this spot, she trimmed a small amount of the mesh that was just excess lateral to where she threaded her suture through the mesh.Ultimately, she was happy with this positioning and tensioning, and it was reported that it did appear to lay and be under the kind of tension considered normal.She applied topical estrogen cream and was sending the patient home with a catheter for 2 weeks & will do voiding trial at 2 weeks.The only part of the sling that wasn't implanted was the full length of altis adjustment suture.That was discarded.

Event Description

This follow-up mdr is created to document the additional event information received for record #(b)(4).According to the available information the date of the altis procedure was (b)(6) 2020.Information received indicated: ¿the physician set out today to implant an altis and do a plication posterior prolapse repair and suspension to sacrospinous ligament (concomitant w/ altis but nothing coloplast used for this prolapse procedure.) altis was implanted and then the physician cysto'd.While cystoing she noticed fluid coming from somewhere other than meatus.Upon further inspection the physician recognized the old fistula had created a lateral opening off the urethra.At this time the territory manager cited implanting altis w/ fistula is contraindicated.The physician acknowledged she knew that, said the fistula opening was lateral & distal to where the altis was being implanted.She proceeded to stitch up the fistula opening, took a graft of anterior vaginal wall and stitched that over the fistula opening repair, and implanted altis.While tensioning altis, she ran out of adjustment suture length and when she tried to force the adjustment suture, not knowing the dynamic anchor was right up against the mesh, the suture broke.I advised the best option was to explant this altis and implant another one.Dr a shared she had stitched her fistula opening repair around the static side mesh and so she didn't want to explant that mesh or try to re-anchor another altis on that static side.So, she said she decided to anchor a polyprolene suture into the dynamic side obturator internus then threaded both ends of that suture through the dynamic side of the mesh and tie it down.She tried several different positions on the mesh this way before she felt when tied down the mesh was laying and under tension the way she customarily likes to see altis lay under the urethra.Once she found this spot, she trimmed a small amount of the mesh that was just excess lateral to where she threaded her suture through the mesh.Ultimately, she was happy with this positioning and tensioning, and with my eye it did appear to lay and be under the kind of tension i'd consider normal.¿ no components were received for evaluation.Without the benefit of analyzing the components, quality cannot confirm any observations or comment on the condition of the product.If the components become available, or additional information is received, the complaint will be re-evaluated according to procedures.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10537649
• MDR Text Key: 207335536
• Report Number: 2125050-2020-00861
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1