MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT RETROPUBIC DEVICE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810041BL

Device Problem Migration (4003)

Patient Problems Erosion (1750); Prolapse (2475)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure in 2016? the diagnosis and indication for the index surgical procedure in 2017? were any concomitant procedures performed in 2016 or 2017? other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure in 2016? were any concurrent devices implanted in 2016 or 2017? were there any intra-operative complications in 2016 or 2017? when was the mesh exposure first noted by a physician? please provide the mesh exposure site/location, symptoms and diagnostic confirmation for the event in 2023.Describe any medical/surgical intervention for exposure including dates and findings.Were any deficiencies or anomalies noted with mesh device? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.Additional information: d4, h4 ¿ the actual device batch number associated with this event is not known.The following possible lot number was reported: 3822871 a manufacturing record evaluation was performed for the possible finished device lot, and no related non-conformances were identified.Related events captured via 2210968-2024-00009, 2210968-2024-00011, 2210968-2024-00012, 2210968-2024-00013.

Event Description

It was reported that a patient underwent an urological procedure for stress urinary incontinence in 2016 and mesh was implanted.This under-urethral mesh had been removed early in its vaginal portion for erosion in 2016 and then put in place a new tvt mesh in 2017.In parallel, in (b)(6) 2023, the patient underwent surgery of promontofixation for prolapse and under-urethral mesh removal of an eroded portion of the mesh.The patient was reviewed in (b)(6) 2023 for removal of the remaining portions of the suburethral mesh.Additional information has been requested.

• Brand Name: GYNECARE TVT RETROPUBIC DEVICE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18425430
• MDR Text Key: 331861417
• Report Number: 2210968-2024-00010
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 810041BL
• Device Lot Number: 3822871
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• 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
• Patient Outcome(s): Required Intervention