MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT SECUR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTS4

Device Problems Material Erosion (1214); Other (for use when an appropriate device code cannot be identified) (2203); Obstruction of Flow (2423)

Patient Problems Adhesion(s) (1695); Bleeding (1738); Erosion (1750); Incontinence (1928); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Obstruction/Occlusion (2422); Treatment with medication(s) (2571); Hospitalization required (2580)

Event Type  Injury  

Event Description

It was reported that a patient underwent total pelvic floor repair procedure in 2007 and mesh was implanted.The patient began to suffer frequent bowel "explosions" and bowel incontinence.The patient experienced four intestinal blockages, and her surgeon told her she would likely suffer from future bowel blockages.The patient stated that her surgeon has told her mesh removal would make the situation worse and may not be possible.No further information was provided.

Manufacturer Narrative

(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

(b)(4).It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2006 and mesh was implanted due to recurrent prolapse, including 2-3 grade of anterior,central and posterior compartments, cystocele,enterocele, rectocele, and sui.It was reported that following insertion the patient experienced pain, erosion, bleeding after intercourse, dyspareunia, adhesions in the abdomen, bowel obstruction, urinary voiding difficulty and complete failure of implant.It was reported that the patient underwent a mesh graft removal on the left in (b)(6) 2007 due to mesh erosion.It was reported that the patient was hospitalized on (b)(6) 2012 and diagnosed with small bowel obstruction and acute kidney failure.It was reported that the patient underwent a laparoscopic cholecystectomy in 2012.It was reported that the patient was hospitalized again on (b)(6) 2013 and (b)(6) 2013 and diagnosed with small-bowel obstruction.(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT SECUR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel PR 0075 4; SZ 00754
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3891658
• MDR Text Key: 4654462
• Report Number: 2210968-2014-08119
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2014

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: 07/31/2008
• Device Catalogue Number: TVTS4
• Device Lot Number: 2951918
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 06/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2006
• 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 Weight: 71