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

Model Number TVTRL

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hematoma (1884); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Unspecified Tissue Injury (4559)

Event Date 10/28/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation cite: archives of gynecology and obstetrics (2022) 305:407¿413.Https://doi.Org/10.1007/s00404-021-06299-x.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (tvt exact retropubic system) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved? patient demographics?.

Event Description

It was reported in a journal article with title: a retrospective analysis of perioperative complications associated with retropubic tension-free vaginal tape in 960 women.The aim of this study was to analyse the perioperative complications of retropubic tvt surgery and their management in 960 consecutive women operated on at one institution by one surgeon between 2011 and 2016.Women undergoing surgery with retropubic tvt between 2011 and 2016 carried out by one surgeon (cr) at the department of gynecology and obstetrics tuebingen were identified and their records were reviewed retrospectively.The operative reports, as well as the postoperative 6-week period, were explored.A visit 6 weeks after the surgical procedure was attended by all patients.Data collected included baseline characteristics, the indication for surgery (stress incontinence or mixed incontinence with a predominant stress component), the presence of primary or recurrent incontinence, previous urogynecological surgeries, additional surgeries performed at the same time with the tvt procedure, type of anesthesia, operating time, type of the inserted retropubic tvt (tvt exact®, ethicon inc.Reported complications included bladder perforation (n=1) bladder lesion of 5 mm length (n=1), voiding problems and residual urine (n=41),stress urinary incontinence (n=1), hematomas in the retzius' space occurred (n=4), urinary tract infections (n=10), vaginal bleeding postoperatively, (n=4), vaginal erosion occurred.(n=1), urge incontinence and suprapubic pain.In conclusion the results of the study show that the retropubic tvt is accompanied by a low number of complications when performed by an experienced surgeon.We regard the retropubic tvt procedure under analgosedation as a very feasible surgical therapy for women affected by stress urinary incontinence or mixed incontinence with a dominant stress component.In spite of slightly higher complication rates in older and overweighted patients as well as in patients with recurrent stress incontinence, the overall number of complications was low.

• 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
• MDR Report Key: 14265931
• MDR Text Key: 290528074
• Report Number: 2210968-2022-03187
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2022

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 Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female