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

Catalog Number TVTRL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Erosion (1750)

Event Date 12/19/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a gynecological procedure with anterior and posterior repair and cystoscopy on (b)(6) 2022 and mesh was implanted.On (b)(6) 2022, severe wound dehiscence was noted.On (b)(6) 2022, the patient underwent sling revision.This event was reported as having a probable relationship with the study device and a causal relationship with the study procedure.Additional information was requested.

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.Additional information was requested and the following was obtained: please provide the patient's demographic information including gender, weight, bmi at the time of index procedure - gender: women , weight: 80 kg, bmi:31 the diagnosis and indication for the index surgical procedure? - pelvic organ prolapsus and stress urinary incontinence were any concomitant procedures performed? - anterior and posterior repair and cystoscopy.Other relevant patient history/concomitant medications? - no.What tissue dehisced? - vaginal epithelium under the mesh what was the tissue condition (normal, thin, calcified, fragile, diseased)? - normal how was the dehiscence managed? - edges of the dehisced epithelium were dissected.Tissue edged brought together with 2.0 vicryl.Please describe any surgical intervention required for the wound dehiscence including date and findings.- mesh sling revision , date: (b)(6) 2022.Please describe the appearance of the mesh during the second procedure.- completely intact and not infected did the operating surgeon observe any mesh deficiency or anomaly before, during, after the mesh placement and during any re-operation? - no what is the physician¿s opinion as to the etiology of or contributing factors to this event? - no clear etiology, wound dehiscence could occur up to %1-5 of the sui surgeries.No contributing factors what is the patient's current status? - she is happy with surgical results.No mesh erosion.Product code and lot number? - sling tvt exact gynecare ¿ device identifier = (b)(4) ¿ lot number: 3941649.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.

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.Additional information was requested and the following was obtained: what was the initial approach for the index surgical procedure? combined anteroposterior repair, retropubic midurethral sling, cystoscopy were any concurrent devices implanted? no.Were there any intra-operative complications? no.When was the mesh exposure first noted by a physician? (b)(6) 2023.Please provide the mesh exposure site/location, symptoms and diagnostic confirmation.Atrophy noted.2 mm mesh exposed in the midline, no sign of active infection.Describe any medical/surgical intervention for the exposure including dates and findings.Surgical intervention is planned: anterior vaginal repair, sling revision, cystoscopy ((b)(6) 2023).

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.Updated information received: adverse event term: mesh exposure.End date : blank: (b)(6) 2023.Outcome : not recovered/not resolved: recovered/resolved without sequelae.

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.Additional information received: adverse event term: mesh exposure; start date: (b)(6) 2023; severity: moderate; relationship to study device: causal ; relationship to primary study procedure: causal; surgical procedure, therapy, or intervention: no.Specify: she will return for another counseling session.She understands that her options are expectant management, using vaginal estrogen and pessaries.Pt may be helpful.Outcome: not recovered/not resolved.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.What was the initial approach for the index surgical procedure? were any concurrent devices implanted? were there any intra-operative complications? when was the mesh exposure first noted by a physician? please provide the mesh exposure site/location, symptoms and diagnostic confirmation.Describe any medical/surgical intervention for the exposure including dates and findings.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

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.Updated information received: adverse event term: mesh exposure.Specify: she will return for another counseling session.She understands that her options are expectant management, using vaginal estrogen and pessaries.Pt may be helpful.Blank.Surgical procedure, therapy, or intervention : no, yes.Specify : blank: she was undergone surgery.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• 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: 17460425
• MDR Text Key: 320407774
• Report Number: 2210968-2023-05629
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

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 Expiration Date: 03/31/2023
• Device Catalogue Number: TVTRL
• Device Lot Number: 3941649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 08/11/2023; 08/28/2023; 09/14/2023; 04/29/2024
• Supplement Dates FDA Received: 08/25/2023; 08/31/2023; 09/18/2023; 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 80 KG