MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 830041BL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The patient demographic info: age, gender, weight, bmi at the time of index procedure date of initial surgical procedure what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications product code and lot #.What is physician¿s opinion as to the etiology of or contributing factors to this event? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? date and results of mesh excision? what is the patient¿s current status? to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a gynecological procedure and mesh was implanted.The patient experienced extrusion and underwent excision of the exposed mesh.Additional information has been requested.

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Additional information was requested and the following was obtained: date of initial surgical procedure: - (b)(6) 2015.What were current symptoms following the index surgical procedure: onset date: - noticed symptoms early (b)(6) 2016,slight bleeding during intercourse and partner could feel something during intercourse.Other relevant patient history/concomitant medications.- no significant past medical history or medications.Product code and lot #.- product code: 830041bl, lot: 3799432.What is physician¿s opinion as to the etiology of or contributing factors to this event: - no contributing factors, intraoperative complications or concurrent procedures.When was the mesh exposure first noted by a physician: - seen by consultant in clinic on (b)(6) 2016.Mesh exposure site/location, symptoms and diagnostic confirmation: - vagina (1-2mm, 1cm distal to meatus).Date and results of mesh excision: - removal of exposed tvt mesh under local anaesthetic on (b)(6) 2016.What is the patient¿s current status: - followed up by telephone on (b)(6) 2016.All well, no further problems.Stress incontinence remains cured.

• Brand Name: GYNECARE TVT RETROPUBIC SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6061133
• MDR Text Key: 58526684
• Report Number: 2210968-2016-35740
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2016

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 Expiration Date: 09/30/2017
• Device Catalogue Number: 830041BL
• Device Lot Number: 3799432
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 82