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

Model Number 5196501022

Device Problems Unexpected Therapeutic Results (1631); Insufficient Information (3190)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Urinary Retention (2119); Urinary Frequency (2275); Dysuria (2684); No Information (3190)

Event Date 02/28/2017

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.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

Patient implanted with altis.Event 1 reported on (b)(6) 2016: slow urine flow and dysuria.Onset event : (b)(6) 2016 full description - slow urine flow and dysuria with pvr=200 ml (no retention).Treatment : no treatment, simple follow-up because no retention.Status of the event : on going event 2 - urge incontinence.Date of onset event: (b)(6) 2016 full description- urge incontinence (leakage not due to stress component).Aggravated pre-existing incontinence.Occurence of a major pollakiuria with micturation every hour preventing the patient from going out.The patient gets up more than 8 times during the night, no real leakage but confusion by the patient between leakages and urgent uria without stress leakage as before previous context of a bladder hypersensitivity during filling with tendency to pollakiuria in view of the pre-operative voiding diary, then occurrence of chronic retention with pvr> 250 ml treatment: anticholinergic treatment started for underlaying overactive bladder and bladder hypersensitivity which were unmasked after altis procedure (because underlying pollakiuria).No immediate effect, proposal for physical exercises and posterior tibial neuromodulation.Hospitalization for altis revision on (b)(6) 2017 (section of the device without removal).Device remains implanted status of the event: on going.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information and updated patient, device and method codes.The device remains implanted.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.However, because quality's examination may not conclusively confirm or disprove the report of slow urine flow, dysuria, or urge incontinence, quality accepts the physician's observations.This complaint was forwarded to the contract manufacturer (cm) for review.The cm was not able to confirm the complaint or investigate further due to the lot number not being provided.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, and because the device is not available for evaluation, no further corrective action is required at this time.

Event Description

Additional information received indicated anticholinergic treatment started for underlying overactive bladder and bladder hypersensitivity which were unmasked after altis procedure (because underlying pollakiuria).No immediate effect, proposal for physical exercises and posterior tibial neuromodulation on 08 dec 2016 (urodynamics).Hospitalization for altis revision on (b)(6) 2017 (section of the device without removal).New check-up on 07 april 2017 for control micturition.Event resolved on (b)(6) 2017.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 6456537
• MDR Text Key: 71618659
• Report Number: 2125050-2017-00056
• 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,study
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5196501022
• Device Catalogue Number: 5196501022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR