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

Model Number 5196502400

Device Problem Migration (4003)

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475); Dysuria (2684); Device Embedded In Tissue or Plaque (3165); Urethral Stenosis/Stricture (4501)

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 stitch discomfort, separation of perineum 1-2 mm deep, urinary tract infections, slower than normal urinary stream, sensation of urethra, urinary obstruction, pelvic pain, chronic pelvic pain, small midline abdominal adhesion and thigh pain.Patient had explantation of the device via general anesthesia.Pathology report showed synthetic mesh consistent with device.Patient had a vaginal device complication; an ultrasound showed a possible foreign body.Patient had an incision and removal of a foreign body deep in the obturator externus muscle complicated right and left, via general anesthesia.The pathology report showed soft tissue, obturator externus muscles, right thigh, excised mature skeletal muscle and fibrous tissue with atrophy and reactive changes.Patient had robotic-assisted, laparoscopic transabdominal explantation of another manufacturer's soft device from bladder sacrocolpopexy device, posterior colporrhaphy with repair rectocele and perineorrhaphy, perineorrhaphy revision via general anesthesia.

Event Description

Additional information received on (b)(6) 2023 indicates that the patient was experiencing dysuria and incomplete bladder emptying.

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.

Event Description

Additional information received on 4/3/2023 provided the following information: the patient also suffered scarring, inflammation and vaginal prolapse.

• 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: 16084142
• MDR Text Key: 306493336
• Report Number: 2125050-2022-01455
• 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,Followup,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6437493
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2023
• Date Device Manufactured: 12/05/2018
• 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: 68 YR