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

Catalog Number 510041

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

Patient Problems Abscess (1690); Erosion (1750); Calcium Deposits/Calcification (1758); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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 and name of index surgical procedure? the initial approach for the index surgical procedure? the diagnosis and indication for the index surgical procedure? was cystoscopy performed after the initial insertion of tvt to confirm it was not inadvertently placed into the bladder? any concurrent procedure/device implantation? were there any intra-operative complications? are there any pictures available for evaluation? other relevant patient history/concomitant medications.Lot # mm4dcca is not valid.Please confirm product code and lot number.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? adverse event related to cystotomy on (b)(6) 2008 reported via mw#2210968-2019-78714.

Event Description

It was reported that the patient underwent a gynecological procedure in 2000 and mesh was implanted.On (b)(6) 2008, the patient underwent cystotomy for a partial resection in intra vesical of the mesh was performed because the patient expressed discomfort.On (b)(6) 2018, the patient underwent cystoscopy which showed a calculus of 15 mm about attached to a mesh fragment at the level of right side of the bladder.An extraction of the calculus and of the remaining fragments of mesh was performed.Additional information has been requested.

Manufacturer Narrative

Additional patient codes: 1690, 1750, corrected device codes: 4003.Additional information was requested, and the following was obtained: the initial approach for the index surgical procedure? april 2000: rachianesthesia.Infiltration of the posterior surface of the pubic symphysis with xylocaine adrenaline 1% diluted to provide a retro pubic space.Then preparation of two incision above pubic located 2cms on both sides of the median line.Urethral incision 1 cm from the meatus.Paraural tunelling up to the deep surface of the pelvic fascia.Induction of the right tvt trocar.The correct position is controlled by cystoscopy.The same maneuver is performed on the left.Moderate adjustment of the tension of the strips.With cough, a drop of urine remains on the meatus.Closure of the urethral incision and cutaneous incisions with vicryl 0 rapid.Set up a vaginal wick and bladder catheter for 24 hours.Was cystoscopy performed after the initial insertion of tvt to confirm it was not inadvertently placed into the bladder? yes.Any concurrent procedure/device implantation? no.Were there any intra-operative complications? no.Are there any pictures available for evaluation? no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? operative report urology (2008): patient with cystalgia on a submucosal tvt strip that has eroded the mucosa and created a painful parietal lithiasis.A fibroscopic cystoscopy has confirmed the diagnosis, but endoscopic excision seems quite random insofar as there is a long mucosal and intramural path.Indication of cystotomy, partial excision of the strip: under general anesthesia, placement of a urethral probe 16, balloon inflated to 10 cc in the bladder.Bladder filling at 200cm.Short median above pubic.Normal penetration.Cystotomy suspension.On the right is the lithiasis attached to the bladder wall and the bladder is put in tension, one finds the strip which is released on its intra-parietal course on 2cms and sectioned.Operative report urology (2018) : this is a woman who has been feeling vaginal foreign body for several months.She saw the gynecologist, who visualized an intravesical echogenic image in ultrasound.Mrs (b)(6).Had an tvt intervention in 2000.Partial resection of the intra-vesical band was performed on (b)(6) 2018 by cystotomy.This procedure had been complicated by a wall abscess.Intervention: in gynecological position, under local anesthesia with xylocaine gel.Easy introduction of the olympus flexible cystoscope.Visualization of a calculation of about 15 mm for a fragment of strip located at the level of the right lateral face near the neck.What is the patient¿s current status? after the procedure in 2018, the patient is doing very well.

• Brand Name: TVT DEVICE WITH PROLENE TAPE
• 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: 8311940
• MDR Text Key: 135212086
• Report Number: 2210968-2019-78713
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 510041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 59