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 Hemorrhage/Bleeding (1888); Unspecified Kidney or Urinary Problem (4503)

Event Date 03/06/2023

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 name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? were any concomitant procedures performed? other relevant patient history/concomitant medications? when did the bleeding occur? how was the bleeding treated? please describe any medical/surgical intervention required including results.Were there any deficiencies or anomalies noted with the device prior to, during or after the procedure? 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2023 and mesh was implanted.On 06-mar-2023, mild voiding dysfunction was noted.There was no medical or surgical treatment for the voiding dysfunction.The event was recovered without sequelae as of (b)(6) 2023.In (b)(6) 2023, mild vaginal bleeding was noted and cystoscopy was performed.This event has not been resolved.Both events were reported as possibly related to the study device and study procedure.Additional information has been 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: a3, a4, b7, e1 additional information was requested and the following response was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure female, 81.9kg, 29.15 name of index surgical procedure? sling operation for stress incontinence the diagnosis and indication for the index surgical procedure? stress incontinence what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? vaginal were any concomitant procedures performed? yes other relevant patient history/concomitant medications? no when did the bleeding occur? started in (b)(6) 2023 how was the bleeding treated? cystoscopy ¿ hasn¿t followed up since yet please describe any medical/surgical intervention required including results.Did cystoscopy to look for bleeding ¿ was normal were there any deficiencies or anomalies noted with the device prior to, during or after the procedure? no what is the physician¿s opinion as to the etiology of or contributing factors to this event? pre-menopause what is the patient's current status? not recovered as far as we know.

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 updated response was received: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure 41, female, 81.9kg, 29.15 name of index surgical procedure? sling operation for stress incontinence the diagnosis and indication for the index surgical procedure? stress incontinence what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? other ¿ vaginal were any concomitant procedures performed? yes, cystoscopy.Other relevant patient history/concomitant medications? no.When did the bleeding occur? started in (b)(6) 2023.How was the bleeding treated? following up with general gyn please describe any medical/surgical intervention required including results.Cystoscopy to explore for bleeding in bladder ¿ came back normal were there any deficiencies or anomalies noted with the device prior to, during or after the procedure? no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? likely related to uterine/possibly hormonal factors ¿ no evidence its related to sling what is the patient's current status? ongoing following up with general gyn.

• 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: 18768928
• MDR Text Key: 336189617
• Report Number: 2210968-2024-01801
• Device Sequence Number: 1
• Product Code: OTN
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: TVTRL
• Device Lot Number: 3942334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 81 KG