MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Foreign Body In Patient (2687)

Event Date 10/31/2012

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 clarify 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.Does the surgeon believe that any of the 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 any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? did the patient receive any medical or surgical intervention for the vaginal exposure or retention of the plastic sheath and positioning line? citation: doi: http://dx.Doi.Org/10.1016/j.Gyn.2012.08.007.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: "tvt abbreve procedure: don't forget to remove the set of positioning line!" although there are currently only three surgical approaches for the treatment of stress urinary incontinence (sui) (the inside-out and outside-in transobturator approaches and the retropubic approach), a host of suburethral slings is available.Even if they are similar in appearance, each of them has their own special characteristics.It was a case of a female patient referred to the unit for dyspareunia in the wake of a sui treatment involving the installation of the tvt abbrevo implant (ethicon).The clinical examination revealed left anterolateral vaginal mesh exposure with a plastic sheath and set of positioning line that was left.Although it is derived directly from the tvt-o slings, its particularity is to limit perforation of the obturator membrane in order to minimize postoperative pain in the upper thigh region.The polypropylene sling, shorter (12 cm) than a standard tvt-o sling is surrounded on either side by positioning lines also made of polypropylene, surrounded by a protective polyethylene sheath.The surgeon who operated on this patient was familiar with the tvt-o technique using the inside-out approach, but he had not received specific training on the tvt-o abbrevo technique.In this era of widespread industrial innovation producing a growing number of new products, it seems that emphasizing the importance of training for surgeons on each new technique available on the market is critical.

• Brand Name: TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11084023
• MDR Text Key: 224799498
• Report Number: 2210968-2020-10347
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K100936
• 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: 12/09/2020

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: 12/09/2020
• Initial Date FDA Received: 12/28/2020
• 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