MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH

Model Number 5196501022

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Hematuria (2558)

Event Date 03/24/2018

Event Type  Injury  

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.

Event Description

According to the available information, a (b)(6) patient experienced sling erosion and migration after altis procedure.Date of procedure: (b)(6) 2018.Date of onset event: (b)(6) 2018.Description of the event: on (b)(6) 2018 : during the post op consultation, the patient reported 2 episodes of hematuria (pushing for a bowel movement) on (b)(6) 2018 : following the episodes of hematuria, the surgeon did a fibroscopy to determine the cause.Fibroscopy showed the sling in the urethra.The surgeon wrote "very fast erosion and migration in (b)(6) 2018, no leaks, no urinary pain.It must be removed by vaginal endoscopy +/- urethrotomy if necessary ».On (b)(6) 2018: revision of altis sling.The surgeon has planned to see again the patient (date not provided).Treatment : revision of altis sling by vaginal route on (b)(6) 2018: blind cut of the sling on each side of the urethra, to release the part into the urethra.The surgeon did not remove the cut part because he did not find it.In the urethra, he had seen her on the side, so it may be under the mucous membranes status of the event : on going.According the surgeon, the event is possibly related to the procedure and the device but he is not sure.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.The device is not available for evaluation.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the device.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 5559448.The most likely root cause of the event cannot be determined at this time.If the device or additional information is received, quality will re-evaluate this event in accordance with procedures.This complaint was forwarded to the contract manufacturer (cm) for review.The cm reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, no further corrective action is required at this time.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7856210
• MDR Text Key: 119567685
• Report Number: 2125050-2018-00641
• 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: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

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 Model Number: 5196501022
• Device Catalogue Number: 519650
• Device Lot Number: 5559448
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 65