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

Model Number 5196502400

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Erosion (1750); Micturition Urgency (1871); Perforation (2001); Urinary Retention (2119); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Dyspareunia (4505); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

Should additional information 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

Gromicho a, dias j, araújo d, rodrigues r, kheir gb, ferraz l.Long-term outcomes of altis® single-incision sling procedure for stress urinary incontinence.Int urogynecol j.2021 aug 2.Doi: 10.1007/s00192-021-04936-2.Epub ahead of print.Pmid: 34338824.Gromicho a, bou kheir g, araújo d, rodrigues r, pereira d, dias j, ferraz l.Long-term outcomes of altis® single-incision sling procedure for stress urinary incontinence.Eur urol(s1):s141.According to the available information, 145 women with clinical stress urinary incontinence (sui) were implanted with altis slings between april 2012 and december 2015.From these, 131 women were available for revaluation in january 2021.Post operative complications included two cases of vaginal extrusion requiring surgical removal of the eroded mesh segment; three cases of infravesical obstruction which led to sling section; de novo urgency in 20 patients, successfully managed with anticholinergic drugs; and at the eight-year follow-up, mild dyspareunia in two patients.Two patients experienced early postoperative vaginal bleeding, and eight experienced transient urinary retention.Four women experienced exposure of the adjustment threat, and eight experienced urinary tract infections.Thirty-five patients had treatment failure, 28 patients self-reported sui, and seven women had been reoperated owing to the reappearance of sui or complications.Five patients had a vaginal fornix perforation detected intraoperatively, requiring repair of the vaginal wall and formation of a deeper subcutaneous path for placement of a new mesh.Regarding patients with vaginal exposure of the tension adjustment thread (and without extrusion of the mesh), the thread was cut short in the office and topical estrogens were prescribed.It was reported that the median age of the women was 50 years.

• 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: 12657484
• MDR Text Key: 277178615
• Report Number: 2125050-2021-01510
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2021
• Initial Date FDA Received: 10/19/2021
• 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: 50 YR