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

Model Number 5183301000

Device Problem No Apparent Adverse Event (3189)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information, though not verified, malfunction: "(b)(6) years old".The device was removed/ replaced.Available for return.Additional info.Per tm on (b)(6) 2020: "the physician stated that it had been in a really long time and the device wasn't as efficient as the patient would like.He said nothing really malfunctioned on it, it was just old and not working as well as he'd like." the lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Manufacturer Narrative

Examination of the surfaces of the reservoir strain relief and poppit revealed markings indicating contact with unshod instrumentation.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the reservoir strain relief and on the reservoir poppit occurred after the device packaging was opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, it was concluded that the separation most likely occurred during or after explant.This separation is not associated with the cause for failure.The information received indicated there was a possible malfunction with the device due to being old and not working as well as the patient would like.However, because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.As examination of the device may not conclusively confirm or disprove the effect of capsular formation, quality accepts the physician¿s observations as to the reason for surgical intervention.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11152714
• MDR Text Key: 226312792
• Report Number: 2125050-2021-00031
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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 Operator: Health Professional
• Device Model Number: 5183301000
• Device Catalogue Number: 518330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR