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

Model Number 5196502400

Device Problems Material Deformation (2976); Migration (4003)

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Fistula (1862); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Tissue Damage (2104); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Obstruction/Occlusion (2422); Hematuria (2558); Blood Loss (2597); Intermenstrual Bleeding (2665); Dysuria (2684); No Information (3190); No Code Available (3191); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.(b)(4).

Event Description

As reported to coloplast though not verified, patient's legal representative stated erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), urinary dysfunction, blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, and chronic pelvic pain, emotional distress and mental anguish and other debilitating complications.Undergo operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine and vagina and operations to remove portions of the female genitalia.Obturator neuralgia, hip abductor myalgia, pelvic tendon and pelvic floor myalgia, painful bladder filling, impaired mobility due to chronic inflammatory response, impaired sexual function, impaired bladder function, recurrent infections, recurrent incontinence, impaired bowel function, scar plate formation, adhesions, migration.Fibrosis of muscles, adhesions between tissues, inflammation, and pull or compress nerves.Impaired gait secondary to spasms of the obturator internus muscle, vaginal and vulva allodynia, anorectal pain, chronic cystitis, interstitial cystitis, vaginal erosion, hip adductor myalgia, pudendal neuralgia, complex regional pain syndrome.

Event Description

Additional information received further reported that the patient also experienced: dysuria, pelvic cramping, vaginal bleeding on the right side wall of the vaginal canal, brown discharge on the suture site, pain and burning sensation with urination, urgency, frequency, retention, atrophic vaginitis, urinary tract infections were positive for enterococcus faecalis group d, klebsiella oxytoca, and klebsiella pneumoniae.The patient also experienced erythema, hematuria, partial bladder outlet obstruction, and detrusor instability.Transvaginal excision of the altis sling took place, as well as anterior repair with kelly plication.Intraoperative findings: the area of the mid urethra was found to be involved and a significant and dense scar healed.There was extensive scarring of the mid urethra with partial bladder outlet obstruction.There was particular scarring on the right mid urethra with a previously noted sling was palpated.There was dense scarring enveloping the sling remnant.After the extensive dissection, a residual piece of mesh sling was found on the right hand side at the mid-level of the urethra.The final diagnosis was foreign body giant cell reaction and minimal chronic inflammation.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received indicates that the patient is also experiencing mild spotting, frequent urination, hematuria and urinary tract infections.

• 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 (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 9997891
• MDR Text Key: 189499164
• Report Number: 2125050-2020-00358
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2024

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 Expiration Date: 10/05/2020
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5757031_5196502400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 02/24/2022; 05/22/2023; 05/22/2023
• Supplement Dates FDA Received: 09/20/2022; 05/30/2023; 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• 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): Hospitalization; Required Intervention
• Patient Sex: Female