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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120)

Event Date 07/17/2023

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report, and capa.No ncs nor capas were identified.There were several complaints identified against this lot; however, with various adverse events and failure modes.Therefore, this is not considered a trend.Devices met specification prior to release.

Event Description

According to available information, this device required explantation due to exposure.The device moved in the vagina.The patient had a recurrence of urine leakage, pain, a sensation of an intra-vaginal foreign body and recurrent urinary tract infections.No other adverse patient effects were reported.Additional information received on 8/9/2023 states the patient experienced urine leakage and recurrent urinary tract infections.

Event Description

According to the available information the altis was to be implanted on (b)(6) 2016.The patient reported experiencing vaginal exposure and pain.Therefore, the patient underwent revision to explant the mesh.The exposure led to a recurrence of urine leakage, pain, a sensation of an intra-vaginal foreign body and recurrent urinary tract infections.

Manufacturer Narrative

The device was not returned for evaluation.However, because examination of the returned components may not conclusively confirm or disprove the report of exposure which allegedly resulted in additional physiological responses, quality accepts the physician¿s observations of such as the reason for surgical intervention.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• 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: 17721358
• MDR Text Key: 323098763
• Report Number: 2125050-2023-00983
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932431484
• UDI-Public: 5708932431484
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/12/2019
• Device Catalogue Number: 519650
• Device Lot Number: 5030891_5196501022
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 05/12/2016
• 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: 61 YR