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 Problem Hemorrhage/Bleeding (1888)

Event Date 08/10/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2023 and mesh was implanted.The patient was out of the operation room after the first surgery at 14:25 pm.Vaginal bleeding was noticed at 15:08 pm.Second surgery for vaginal exploration and exam under anesthesia re-closure of anterior vaginal repair with application of hemostatic agents started at 15:33 pm.Exam under anesthesia showed about 400 cc of blood and lot in the vaginal vault.The area was irrigated and the anterior vaginal incision was visualized.Anterior wall with continued/persistent bleeding.No active vessel bleeder was noted.Mus site hemostatic.Re-closure of anterior vaginal repair with application of hemostatic agents was performed.The bleeding was controlled with the procedure.This event was reported as not related to the study device, but a causal relationship with the study procedure.Additional information was provided.

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 followup 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.Women, 68 kg, bmi: 26.6.Name of index surgical procedure? combined anteropsterior repair, retropubic midurehtral sling, cystoscopy.The diagnosis and indication for the index surgical procedure? sui and pop.Were any concomitant procedures performed? yes.What symptoms did the patient experience following the index surgical procedure? onset date? index surgery was uneventful.Other relevant patient history/concomitant medications? no relevant history or concomitant medications.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? vaginal.When did the bleeding occur? the patient was out of the operation room after the first surgery at 14:25 pm.Vaginal bleeding was noticed at 15:08 pm.Second surgery for vaginal exploration and exam under anesthesia reclosure of anterior vaginal repair with application of hemostatic agents started at 15:33 pm.What was the source and triggering event of bleeding? no source or trigger was identified.How was the bleeding treated? with a concomitant surgical procedure: vaginal exploration and exam under anesthesia reclosure of anterior vaginal repair with application of hemostatic agents.Please describe any medical/surgical intervention required including results.Vaginal exploration and exam under anesthesia reclosure of anterior vaginal repair with application of hemostatic agents.Bleeding was controlled with the procedure.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? no clear etiology was identified.What is the patient's current status? she is currently doing well.Product code and lot number? tvt exact gynecare, device identifier: (b)(4), lot number: 3943248.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.

• 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: 17712252
• MDR Text Key: 322978968
• Report Number: 2210968-2023-06509
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: TVTRL
• Device Lot Number: 3943248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 68 KG