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

Model Number 5196502400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Pain (1994); Skin Erosion (2075); Dyspareunia (4505)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced the following events/symptoms on the following dates: (b)(6) 2019: partner notices a scratch during sexual activity.Physical exam revealed impending exposure of the anchor of the sling on the left side.Mildly tender.(b)(6) 2019: mesh erosion, mesh exposure at the inferior pubic ramus, pain at site of the left anchor insertion, dyspareunia, urethral hypermobility, sui (b)(6) 2019: transurethral removal and complete excision of mid urethral sling (altis), repair of urethral injury with urethrorrhaphy, kelly urethral plication ¿ general anesthesia intraoperative findings: there was significant injury to the corpus spongiosum and suburethral tissue.Pathology report: excised sling: fragments of synthetic mesh material and fibrocollagenous tissue with presence of synthetic material associated with inflammation and fibrosis.Also present are fragments of vaginal mucosa.Synthetic mesh materials within incorporated soft tissue measuring 9.5 x 0.5 x 0.2 cm in loose aggregate.

Event Description

Additional information received on 11/3/2022 as follows: beginning (b)(6) 2020 through (b)(6) 2022 the patient experienced recurrent erosion of a synthetic piece of material in the left vaginal crux, dyspareunia, 3rd degree rectocele, slow weak stream, not sure is she empties well.Recurrent erosion of a synthetic piece of material in the left vaginal crux, dyspareunia, 3rd degree rectocele.The patient underwent a cystoscopy with removal of portion of urethral sling, vaginoplasty, and excision of vaginal polyp under general anesthesia.Small mesh erosion was observed with partner feeling poking with intercourse.A cystoscopy with excision of eroded urethral sling was performed under iv sedation.Small sling erosion was observed with palpable mesh fibers left vaginal crux, partner feels with intercourse.Eroded urethral sling cystoscopy with excision of eroded urethral sling and transvaginal flap advancement closure under iv sedation.Extruded vaginal mesh with excision of portion of urethral sling under general anesthesia.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 14939271
• MDR Text Key: 295404310
• Report Number: 2125050-2022-00692
• 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,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/13/2021
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5992591
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2022
• Date Device Manufactured: 03/14/2018
• 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: 53 YR
• Patient Sex: Female