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 Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, non-conforming report and capa.Devices met specification prior to release and no trends were noted.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

According to available information, this device required replacement due to becoming loose.The fixed anchor spontaneously loosened during the procedure.The device appeared to have detached from the fixed anchor after a smooth placement and without much tension.The device was not pulled on or cut.

Event Description

According to the available information this altis sling was to be implanted on (b)(6) 2023 but was not due to the static anchor spontaneously loosening during the procedure.The altis mesh appeared to have detached from the static anchor after a smooth placement and without too much tension.A new altis was placed without issue.

Manufacturer Narrative

An altis sling and two introducers were received for evaluation.Examination of the sling revealed that the dynamic suture, anchor, and tensioner were still attached to the sling.The static anchor and suture were detached and not received.Microscopic examination of the static suture that was still attached to the mesh revealed rough and irregular surfaces, indicating stress was exerted.Blood residue was noted on the sling.No abnormalities were noted with either introducer.Based on examination of the returned product, the static suture and anchor detached from the mesh while trying to implant.No information was received indicating the location where the sling was implanted or the size of the patient¿s pelvis, which may have been contributors to the difficulty the physician encountered.A review of the device history record by the contract manufacturer 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: 17495614
• MDR Text Key: 320751206
• Report Number: 2125050-2023-00958
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05701780274807
• UDI-Public: 5701780274807
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 519650
• Device Lot Number: 9018094_5196504022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2023
• Date Device Manufactured: 04/03/2023
• 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