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

Catalog Number 810041B

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Adhesion(s) (1695); Erosion (1750); Irritation (1941); Pain (1994); No Code Available (3191)

Event Date 06/15/2016

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.

Event Description

It was reported that the patient underwent an unknown laparoscopic procedure on (b)(6) 2016 and mesh was implanted.Two weeks post op, the patient experienced pain in the left side that does not go away with medication and is worse when moving.It was reported by the patient that the doctor stated he thinks the mesh sling has penetrated/attached to the lining /first layer of the bone.The doctor suggested that the mesh be removed as pain is not improving.No additional information was provided.

Manufacturer Narrative

The following information has been requested, but no response has been received.Should any additional information be provided, a supplemental 3500a will be submitted.The patient demographic info: age, weight, bmi at the time of index procedure the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to this event? has any medical or surgical intervention been provided? please include dates and results.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

(b)(4).Corrected date of event information: event (b)(6) 2016.Additional information was requested and the following was obtained: the diagnosis was stress urinary incontinence.She had urodynamic studies prior to surgery which demonstrated no contraindication.At the same time she had a diagnostic laparoscopy, drainage of ovarian cyst, anterior repair (without mesh) and a perineal repair.Current symptoms are pain- lower abdomen and groin/leg- which is worse on the left side and with movement.It is anatomically associated with the tvt exit point.The surgery was performed (b)(6) 2016.She first consulted me with these symptoms on (b)(6) 2016.There is no other relevant history or medication.Aetiology wise i suspect irritation of the posterior aspect of the pubic bones from the tvt.There has been no intervention to date.A cystoscopy and mri were normal.She has been referred to a physiotherapist but symptoms have not improved.She is scheduled for surgery to remove the tvt on (b)(6) 2017.

• 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: 6200717
• MDR Text Key: 63170799
• Report Number: 2210968-2016-36908
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 810041B
• Device Lot Number: 3872060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2015
• 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: 42 YR
• Patient Weight: 87