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

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

Patient Problems Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475)

Event Type  Injury  

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.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.(b)(4).

Event Description

According to the available information, in 2017, the patient experienced stress incontinence, right flank pain, fever, urinary tract infection, urinary retention for which a foley catheter was placed, hematuria, decreased urinary output from foley catheter, severe abdominal pain, pelvic pain, overactive bladder, an inflamed urethra, severe urethral and vaginal pain, leakage with frequency and nocturia, weak and slow urinary stream, spraying upon urination, urethral and vaginal pain, incomplete bladder emptying, urgency, and left ureterolysis.In 2018, the patient experienced urinary leakage, stress incontinence, urge incontinence, frequency, dysuria, difficulty emptying the bladder, vaginal discharge, pelvic pain, recurrence of stress incontinence after sacral colpopexy with dermal graft for recurrent prolapse, intrinsic sphincter deficiency with type 3 stress urinary incontinence, a sling revision occurred, urethral lysis, and placement of retropubic mesh tape with cystoscopy.The product was explanted.In 2019 the patient continued to experience incontinence and pelvic pain.

Manufacturer Narrative

According to the available information the date of the altis procedure was (b)(6) 2017.The device was explanted on (b)(6) 2018.Information received indicated: ¿incontinence, right flank pain, fever, uti, urinary retention, hematuria, oab, sui, inflamed urethra, nocturia.¿ no components were received for evaluation.As examination of the components may not conclusively confirm or disprove the report of infection quality accepts the physician¿s observations as to the reason for surgical intervention.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

Event Description

As reported to coloplast, though not verified, additional information received on (b)(6) 2021.Pelvic and perineal pain, low back pain, poor urinary stream, straining to void, nausea and vomiting, dyspareunia.Lsc pelvic scar tissue removal, lsc sacral colpopexy with fortiva dermal graft, cystoscopy.Dysuria, vaginal discharge, pelvic pain, and sui.On (b)(6) 2018 - recurrent incontinence, stress and urge.Intrinsic sphincter deficiency with type 3 stress urinary incontinence.Sling revision, urethral lysis, placement of retropubic mesh tape with cystoscopy.(unknown retropubic sling).Xl, loa, resection of pelvic mass due to c/f for ovarian cancer; pathology showed benign inflammation to foreign body/suture.Small subcentimeter area of mesh palpable, graft erosion [possibly retropubic sling placed in 2018 per the medical records].

• 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: 11019490
• MDR Text Key: 221768239
• Report Number: 2125050-2020-01298
• 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: 10/08/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention