MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

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

Patient Problems Hematoma (1884); Pain (1994); Injury (2348); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(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.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 products 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 products used in this procedure? citation: european journal of obstetrics & gynecology and reproductive biology 198 (2016) 78¿83; doi: http://dx.Doi.Org/10.1016/j.Ejogrb.2016.01.012.(b)(4).

Event Description

It was reported via journal article: "title: bladder injury and success rates following retropubic mid-urethral sling: tvt exacttm vs.Tvttm".Authors: thibault thubert, virginie canel, marie vinchant, ingrid wigniolle, herve´ fernandez , xavier deffieux.Citation: european journal of obstetrics & gynecology and reproductive biology 198 (2016) 78¿83; doi: http://dx.Doi.Org/10.1016/j.Ejogrb.2016.01.012.This retrospective study aimed to compare the efficacy and prevalence of complications associated with the two retropubic (rp) midurethral sling (mus).From jan2011 to dec2014, 98 female patients who underwent rp sling procedures of either tvt (n=49; mean age of 55.3±10.3 years) or tvt-exact (n=49; mean age sd of 56.3 ± 14.1 years) for stress urinary incontinence (sui) were included in the analysis.In both treatment groups, surgical procedures were performed using vaginal route and the only difference were the type of trocar used to where in tvt-e, the trocar consists of a non-sterile reusable instrument 3 mm in diameter with a single-use trocar handle that is more ergonomic than in the tvt device; while in tvt, the trocar handle is a stainless steel reusable instrument, whereas the other part of the trocar is non-sterile and reusable and measures 5 mm in diameter.Both procedures use the same prolene polypropylene mesh.Intraoperative findings included bladder injury (n=4 tvt-exact, n=3 tvt).Postoperative findings included retropubic space hematoma (n=1 tvt-exact, n=2 tvt), dysuria (n=12 tvt-exact, n=3 tvt), postoperative pain (n=49 with mean of 8.0±12.1 in tvt-exact, n=49 with mean of 15.9±18.0 in tvt) treated with postoperative analgesic protocol (paracetamol, ketoprofen and tramadol when vas exceeded 30/100) , first post-void residual volume (pvr) (n=49 with mean of 153.9±228.1 ml in tvt-exact, n=49 with mean of 78.9±121.3 ml in tvt) of which treated with self-catheterization (n=1 tvt-exact and n=1 tvt).At 6 weeks, findings included pain of =20/100 (n=4 tvt-exact and n=1 tvt) of which one and two patients had analgesic consumption, respectively; worse symptoms of bladder outlet obstruction (boo) (n=12 tvt-exact and n=3 tvt), de novo urge symptoms (n=6 tvt-exact and n=2 tvt), de novo boo (n=7 tvt-exact and n=2 tvt).At one year follow-up, findings included worsen symptoms of boo (n=12 tvt-exact and n=6 tvt) and sui persistence or recurrence (n=2 tvt-exact and n=5 tvt) which underwent reoperation.The prevalence of bladder injury was unchanged with the tvt-e.Immediate postoperative pain was decreased following tvt-e compared with tvt.The first post-void residual was increased with tvt-e, but there was no difference when considering only de novo boo.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8210558
• MDR Text Key: 131896542
• Report Number: 2210968-2019-78121
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2018
• 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