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

Catalog Number 810041B

Device Problem Migration (4003)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Pain (1994); Hematuria (2558); Not Applicable (3189)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.This medwatch report is in response to receipt of maude event report mw5086250-1.Patient reported adverse event about 1st interventional surgery since 2018 due to blood in urine with severe abdominal pain and mesh infiltrated the bladder which allows calculi to grow on it, was submitted via medwatch report 2210968-2019-83132.Patient reported adverse event about 2nd interventional surgery since 2018 was submitted via medwatch report 2210968-2019-83133.Patient reported adverse event about 3rd interventional surgery since 2018 was submitted via medwatch report 2210968-2019-83134.

Event Description

It was reported that the patient underwent a gynecological procedure on unknown date and the mesh was implanted.The patient experienced blood in urine with severe abdominal pain.Initial diagnosis was a bladder stone, and the patient was referred to the urologist.After cystoscopy and surgery, it was discovered the mesh infiltrated the bladder which allows calculi to grow on it.The patient underwent a first interventional surgery since 2018.The patient underwent a second interventional surgery since 2018.The patient underwent a third interventional surgery since 2018.Most recent was 2019.It was also reported that this surgery was an aggressive and the patient continue having a painful recovery.It was found that the mesh eroded into the bladder, two thirds of mm from the left under orifice.Specialized doctors are trying to prevent having mesh removal because they opined that it could be a high-risk surgery and the patient could lose the ureter and possibly the left kidney.The patient reported that alternate methods, kegel/pessary, were not an option.It was also reported that the patient experienced severe prolapse where organs involved needed repair/placement.Estrogen prescribed delivered vaginally to strengthen vaginal and bladder walls.The device is still implanted.

Manufacturer Narrative

The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT DEVICE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8725572
• MDR Text Key: 148921191
• Report Number: 2210968-2019-83135
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 810041B
• Device Lot Number: 3732905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention