MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number 519650

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Abdominal Pain (1685); Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Intermenstrual Bleeding (2665); Dysuria (2684); Vesicovaginal Fistula (4512)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced infections, recurrent urinary tract infections, foul-smelling discharge, urinary incontinence, urinary urgency, pelvic pain, vaginal pain, lower abdomen pain, pain with intercourse, vaginal device erosion 1-2 cm in greatest dimension on the posterior apical vaginal wall, large bunch of device eroded at the vaginal apex, erythematous area above trigone with some debris in bladder, overactive bladder, cramping, vaginal bleeding, chronic vesicovaginal fistula, pale yellow liquid pooled in vagina that could be urine, stress urinary incontinence, urinary leakage, cloudy urine, dysuria, foul urine odor, urine dipstick that tested positive for nitrite and leukocytes, urinary leaking around the catheter, bladder spasms and a computerized tomography scan.Patient had explantation of the vaginal device and cystourethroscopy via general anesthesia.Patient had an office cyscopy for device erosion in the vagina and bladder, urinary incontinence, possible vesicovaginal fistula, debris and what looks like a bladder stone.Patient had a cystoscopy with ureteral catheterization bilaterally, a robotic assisted laparoscopic revision of sacrocolpopexy with explantation of the device, a robotic assisted laparoscopic bilateral salpingectomy, and a robotic closure of the vesicovaginal fistula via general anesthesia.Patient had urinary incontinence possibly from absorbable sutures still in the bladder.

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.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17741187
• MDR Text Key: 323355813
• Report Number: 2125050-2023-01126
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/25/2022
• Device Catalogue Number: 519650
• Device Lot Number: 6977903_5196502400
• Date Device Manufactured: 11/04/2019
• 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: 48 YR