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 Erosion (1750); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Frequency (2275); Thrombosis/Thrombus (4440)

Event Date 12/16/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure for stress urinary incontinence on (b)(6) 2022 and mesh was implanted.On the same day, acute/moderate post-op pain was noted.The patient was treated with routine post-op pain control drug therapy and the pain was resolved on (b)(6) 2022.This event was reported as having a probable relationship with the study device and procedure.On (b)(6) 2023, mild urinary frequency was noted and reported as possibly related to the study device and procedure.This was recovered/resolved without sequelae as of (b)(6) 2023.On (b)(6) 2023, moderate gastrointestinal bleeding due stomach erosions was noted and reported as not related to the study device, but possibly related to the study procedure.The patient was admitted to ed, had a blood transfusion, upper endoscopy and follow up with gi.On (b)(6) 2023, severe acute deep vein thrombosis was noted and reported as unlikely related to the study device, but probably related to the study procedure.The patient was admitted to the ed for observation, put on eliquis, and followed up with pcp for repeat blood work, considering iron supplements.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 f, 204, 29.29.Name of index surgical procedure? sling operation for stress incontinence.The diagnosis and indication for the index surgical procedure? stress urinary incontinence.Were any concomitant procedures performed? yes.What symptoms did the patient experience following the index surgical procedure? onset date? (b)(6) 2023 is date she reported to us ¿ low blood pressure, lethargic, dark stool.Other relevant patient history/concomitant medications? no.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? vaginal.What was the source and triggering event of bleeding? erosions in stomach.What was the volume of blood loss? unknown.How was the bleeding treated? blood transfusion.Please describe any medical/surgical intervention required for the bleeding including results.Admitted to ed, had a blood transfusion, upper endoscopy and follow up with gi.Please describe any medical/surgical intervention required for the deep vein thrombosis including results.Admitted to the ed for observation, put on eliquis, and followed up with pcp for repeat blood work, considering iron supplements 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 these events? not clear if this is for gi bleed or dvt ¿ gi bleed is result of stomach erosions, not related to device, possibly related to surgery ¿ dvt unlikely related to device, probable related to surgery what is the patient's current status? ongoing.Product code and lot number? 3942415, tvtrl.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.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: acute deep vein thrombosis drug therapy : no => yes none : yes => no.

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: gastrointestinal bleeding end date : blank - un (b)(6) 2023 outcome : not recovered/not resolved - recovered/resolved without sequelae additional information received: adverse event term: dyspareunia start date: (b)(6) 2024 severity: mild relationship to study device: possible relationship to primary study procedure: possible drug therapy: yes surgical procedure, therapy, or intervention: no non-surgical procedure, therapy, or intervention: yes specify: physical therapy outcome: not recovered/not resolved.

• 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: 17604056
• MDR Text Key: 321754300
• Report Number: 2210968-2023-06095
• 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

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: 07/31/2023
• Device Catalogue Number: TVTRL
• Device Lot Number: 3942415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 09/12/2023; 11/01/2023; 03/04/2024
• Supplement Dates FDA Received: 09/12/2023; 11/07/2023; 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 93 KG