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 Neurological Deficit/Dysfunction (1982); Pain (1994); Injury (2348); Post Operative Wound Infection (2446); Blood Loss (2597); 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.If further details are received at the 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 (tvt and tvt obturator) 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 involved? citation: int urogynecol j (2014) 25:1023¿1030; doi 10.1007/s00192-014-2384-z (b)(4).

Event Description

It was reported via journal article "title: retropubic vs.Transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial" author(s): thomas aigmüller & ayman tammaa & karl tamussino & engelbert hanzal & wolfgang umek & dieter kölle & stephan kropshofer & vesna bjelic-radisic & josef haas & albrecht giuliani & peter f.J.Lang & oliver preyer & ursula peschers & katharina jundt & george ralph & andrea dungl & paul a.Riss citation: int urogynecol j (2014) 25:1023¿1030; doi 10.1007/s00192-014-2384-z.This prospective randomized controlled non-inferiority trial aimed to compare objective and subjective outcomes of retropubic tension-free vaginal tape (tvt) with those of transobturator tape (tvt-o) as primary treatment for stress urinary incontinence (sui) in women.A total of 569 female patients from 25 centers in (b)(6) and (b)(6) were randomized to tvt (n=285; age of 59.7±11.3 years) or tvt-o (n=269; age of 58.6±10.7 years).During the operation, complications included bladder perforation (n=11 tvt group) and intraoperative bleeding (n=2 tvt group, n=3 tvt-o group).In tvt group, complications included acute abdomen (n=1) which showed perforation of the transverse colon at laparotomy and was treated with tape removal and she subsequently did well; a localized wound infection (n=1) which was treated by opening stitch and using local measures; and voiding dysfunction which required tape loosening.In tvt-o group, one patient had voiding dysfunction which also required tape loosening.Procedure-related pain was also reported on tvt group (n=10) and tvt-o group (n=15).In 3 months follow-up, de novo overactive bladder was reported on tvt group (n=10.5%) and tvt-o group (n=10.1%).The results of this trial demonstrated noninferiority between retropubic and transobturator tension-free vaginal tape with regard to postoperative continence and qol and suggest little difference in perioperative problems.

• 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: 7919027
• MDR Text Key: 122049413
• Report Number: 2210968-2018-76151
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 09/05/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/28/2018
• 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
• Treatment: TVT-O
• Patient Outcome(s): Required Intervention