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); Emotional Changes (1831); Erythema (1840); Foreign Body Reaction (1868); Pain (1994); Urinary Tract Infection (2120); Injury (2348); Disability (2371); Dysuria (2684); No Information (3190); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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's legal representative stated patient suffered serious bodily injuries, including but not limited to, foreign body reaction, mesh protrusion, mesh erosion, pelvic pain, bowel problems, urinary problems and other injuries.Per the report, the patient experienced significant mental and physical pain and suffering, disability, impairment, loss of enjoyment of life and sustained permanent injury.The patient has undergone medical treatment.

Event Description

Additional information, as reported to coloplast though not verified, indicated (b)(6) 2019 - excision/revision of the altis sling for eroded mesh.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received further reported the patient had also experienced erythema of the vaginal incision, increased urinary frequency, urinary tract infection, dyspareunia, and it felt like there were teeth in the vagina.The middle portion of the mesh was removed.Further information received indicated the following: on (b)(6) 2018 vaginal exploration, partial excision of altis/coloplast.Intraoperative findings: middle portion of mesh (altis) removed (3-4 mm).Pathology: [specimen sent, no report available].On (b)(6) 2020, dysuria.On (b)(6) 2021, new patient visit - second opinion for pelvic pain, dyspareunia for claimant and spouse, persistent uui, dysuria.On exam palpable scar tissue in anterior vaginal canal.On (b)(6) 2021 urodynamics - significant diuresis.On (b)(6) 2021, some pelvic pain with sitting, states husband can feel the mesh with intercourse, requesting removal of mesh so she can continue intercourse.On exam small area of palpable mesh but not clearly visible, significant surrounding incisional scar tissue near mesh, in-office cystoscopy - normal.On (b)(6) 2021 new patient visit - evaluation for mui, vaginal mesh erosion.Still has some little pieces of mesh that cause dyspareunia and discomfort for spouse during intercourse.No mesh visualized on exam.On (b)(6) 2021, continued mui, pelvic discomfort.On exam mild posterior tenderness, anterior tenderness especially at level of urethral sling, sharp palpable edges of mesh, inflammatory polyps associated with the eroded mesh, no mesh erosion visualized.On (b)(6) 2021 severe sudden onset urinary urgency with occasional leakage, wears a small pad due to anxiety about having urgency, strong urinary stream initially then stream slows down and feels like she is urinating through a straw, discomfort at the end of urination.Mixed urinary incontinence.

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; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 9831080
• MDR Text Key: 183336434
• Report Number: 2125050-2020-00224
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5819132
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 02/12/2020; 01/26/2022
• Supplement Dates FDA Received: 07/30/2020; 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Female