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

Model Number 5196501022

Device Problem Extrusion (2934)

Patient Problem Erosion (1750)

Event Date 06/26/2017

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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the (b)(6) year old patient experienced vaginal extrusion after altis procedure.Sequence of events: on (b)(6) 2015 - alits surgery and hysterectomy.On (b)(6) 2016 - investigator reviewed patient in one-year follow-up visit.There wasn't any complication.On (b)(6) 2017 - the patient reported to investigator that her husband felt the sling during sexual intercourse.The investigator recognized the vaginal extrusion but there were neither infection nor bleeding.According to investigator, the complication is related to progressive postmenopausal vaginal atrophy caused by estrogen deficiency (the patient has general estrogenic treatment) and the friction of the sexual intercourse caused an erosion of the vagina.Treatment: partial section of device and vaginal reconstruction on (b)(6) 2017 (device still implanted).Status of the event: on (b)(6) 2017, investigator reviewed the patient and confirmed that complication was resolved after intervention in (b)(6) 2017 according to investigator the event is related to the device.

Manufacturer Narrative

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 prosthesis.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 4684119.The root cause of the event cannot be determined at this time.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to 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.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information received.

Event Description

Additional information received indicated the vaginal extrusion began in (b)(6) 2016.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7519576
• MDR Text Key: 108439638
• Report Number: 2125050-2018-00386
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2018

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: Lay User/Patient
• Device Model Number: 5196501022
• Device Catalogue Number: 5196501022
• Device Lot Number: 4684119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 04/18/2018
• Supplement Dates FDA Received: 06/11/2018; 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 76