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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Hematoma (1884); Incontinence (1928); 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.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 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: the journal of spinal cord medicine 2017, doi 10.1080/10790268.2017.1393190 please see referenced article attached.(b)(4).

Event Description

Title : management of stress urinary incontinence in spinal cord injured female patients with a midurethral tape ¿ a single center experience.The aim of this retrospective cohort study was to assess the efficacy of mid-urethral tapes (mut) in managing stress urinary incontinence in this population.From 2005 to 2015, a total of 45 spinal cord injury (sci) patients aged 18 to 87 years were diagnosed with pure stress or mixed urine incontinence and their management included a mid-urethral tape insertion.Of these, 41 fulfilled the inclusion criteria but only 38 were included due to missing data.Surgery to insert the mid-urethral tape was carried out under general anesthesia.The authors used tvt (tension-free vaginal tape) (gynecare tvt¿ retropubic system tension-free), tot (transobturator tape) (monarch¿) and single incision miniarc (miniarc®) based on surgeons preference.In total 21 patients underwent a retropubic tvt, 12 underwent an obturator sling monarc and 5 had single incision miniarc.One patient returned to theatre due to a pelvic haematoma following tvt and suprapubic catheter insertion (clavien-dindo grade:iiib).Nine patients (23.7%) develop tape related complications.There were five de novo urgency episodes, three after tvt and two after tot.Other tape related complications included: one vaginal extrusion, one frequent dysreflexia and one worsening of incontinence).There was a single case of vaginal extrusion following tot necessitating tape removal at 4 months.In conclusion, mid-urethral tapes are effective in the management of sui in sci female patients.There are demonstrable improvements in both continence and quality of life.Clearly pre-operative assessment and careful patient selection and pre-operative counseling are required.This surgery should be offered in the setting of a dedicated spinal injuries unit after discussion in a specialist spinal/urology mdt.

• 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: 7950184
• MDR Text Key: 123196140
• Report Number: 2210968-2018-76430
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• 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: 09/13/2018
• 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