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

Model Number 5196502400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Fistula (1862); Incontinence (1928); Unspecified Infection (1930); Urinary Tract Infection (2120); Dyspareunia (4505); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced recurrent urinary tract infections, dyspareunia, and difficulty passing through a catheter.Mid urethral device erosion into urethra with calcifications over top of the device were found during vaginoscopy with cystoscopy examination under anesthesia.Ureterolysis was performed with a partial urethral wall excision, along with a urethral fistula or defect closure that included a complex urethral reconstruction, and extensive vaginal mucosa trimming.It was noted the interoperative findings included a large flap of device from about the six o¿clock to the two o¿clock position and the right side of the device was noted to be banded and completely looped.A large defect within urethra that included extensive edematous mucosa was also noted.The patient also experienced severe intrinsic sphincter deficient type incontinence.Intraoperative findings noted that a stamey needle used as the cooper ligament was not strong enough to use a suture capturing device and the device was implanted restrictively, especially near bladder neck and proximal urethra.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13977073
• MDR Text Key: 288379158
• Report Number: 2125050-2022-00335
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female