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

Model Number 5196502400

Device Problem Migration (4003)

Patient Problems Bacterial Infection (1735); Erosion (1750); Fistula (1862); Micturition Urgency (1871); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Urinary Incontinence (4572)

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, legal representative stated the patient with this device experienced stress urinary incontinence leaks 4 to 5 times per day, needing to change clothes 4 to 5 times per day, urinary urgency and needing to change pads every 2 hours.Patient had issues with urine leaking around catheter, possible bladder spasms, was prescribed oxybutynin and nitrofurantoin.Patient had an exam that found mild vaginal atrophy, moderate urethral hypermobility, weak pelvic floor, and very mild tenderness at right device ¿arm¿ insertion underneath ischiopubic ramus.A urodynamics test was consistent with intrinsic sphincter deficiency.Patient had complete explantation of the device, complex multilayer urethral closure, cystoscopy, and adjacent tissue transfer under general anesthesia.Estimated blood loss was 400ml and patient was discharged with urethral catheter for 3 weeks.Intraoperative findings noted device erosion sub urethral from the approximately 7 o¿clock position on the right side to the 5 o¿clock position on the left side and multilayer closure with adjacent tissue transfer of vaginal muscularis.Pathology noted pieces of scar tissue and some entrapped fragments of device measuring 2.8 x 1.7 x 0.3 cm, fragments of chronically inflamed squamous mucosa with underlying scar tissue and entrapped pieces of device measuring 2.2 x 1.0 x 0.4 cm, and periurethral debridement with pieces of squamous mucosa with underlying chronically inflamed fibromuscular tissue and scar measuring 1.8 x 1.2 x 0.3 cm.Patient had in-office catheter removal and cystoscopy that noted focal catheter cystitis with minimal separation at the 6 o¿clock position of urothelium.Patient had a procedure for suprapubic catheter placement, rectus fascial harvest, pubovaginal device placement, and complex closure of urethrovaginal fistula under general anesthesia.Intraoperative findings noted a 1 mm urethrovaginal fistula in proximal aspect of midurethral that was closed in two layers with additional coverage provided by fascial device and vaginal epithelium, a 4 cm knot apex above fascia.The doctor placed a suprapubic catheter to promote optimal healing.

Event Description

Additional information received on 6/29/2023, states summons received indicating patient was implanted with altis on or about (b)(6) 2015.After, as a result of implantation the patient suffered serious bodily injuries including but not limited to pain.

• 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: 15702074
• MDR Text Key: 302726369
• Report Number: 2125050-2022-01174
• 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: 07/11/2023

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 Expiration Date: 05/21/2018
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 4506645
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/11/2023
• Date Device Manufactured: 05/22/2015
• 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: 43 YR