MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT W/PRLNE BLUE MESH 1 EACH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810041B

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Abnormal Vaginal Discharge (2123); Blood Loss (2597); Not Applicable (3189)

Event Date 05/31/2006

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, weight, bmi at the time of index procedure name of initial surgical procedure? can you confirm that gynecare prolift mesh and gynecare tvt-o mesh were both implanted on (b)(6) 2006? the diagnosis and indication for the initial surgical procedure with prolift and tvt-o? the diagnosis and indication for the surgical procedure with tvt on (b)(6) 2007? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications product code and lot number for tvt-o? product code of prolift mesh? product code of tvt mesh? 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? describe any medical/surgical intervention for exposure including dates and surgical findings.Which mesh type was removed during excision? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Adverse event regarding tvt-o mesh submitted via 2210968-2020-09162.Adverse event regarding prolift mesh submitted via 2210968-2020-09163.Adverse event regarding tvt mesh submitted via.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent a sling procedure and cystoscopy on (b)(6) 2007 and mesh was implanted.The patient experienced mesh exposure with pv spotting in 2015 and underwent partial excision.The patient experienced repeat mesh exposure with bleeding in (b)(6) 2020 and underwent partial mesh excision on (b)(6) 2020.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to fda: 01/22/2021.H6 component code: g07002 - device not returned.Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure: 61y, unsure bmi/weight at time of procedure but currently 75kg and 168.4cm.Name of initial surgical procedure? anterior and posterior vaginal repair, bilateral sacrospinous fixation with mesh (total prolift), tvt-o and cystoscopy.Can you confirm that gynecare prolift mesh and gynecare tvt-o mesh were both implanted on (b)(6) 2006? yes.The diagnosis and indication for the initial surgical procedure with prolift and tvt-o? pelvic organ prolapse and stress urinary incontinence.The diagnosis and indication for the surgical procedure with tvt on (b)(6) 2007? recurrent stress incontinence.What were current symptoms following the index surgical procedure? onset date? unsure onset; vaginal spotting/discharge.Other relevant patient history/concomitant medications ¿ previous hysterectomy, previous bulking agent; mesh exposure 2015 ¿ partial excision.Product code and lot number for tvt-o? not available.Product code of prolift mesh? pfrt01 lot 1403066.Product code of tvt mesh? 810041b lot 3135641.The initial approach for the index surgical procedure? vaginal.Any concurrent procedure/device implantation? only as detailed.Were there any intra-operative complications? nil.When was the mesh exposure first noted by a physician? 2015.Mesh exposure site/location, symptoms and diagnostic confirmation? 2015 ¿ anterior vaginal mesh exposure 4mm; had partial excision; 2020 ¿ 1.5cm midline anterior vaginal mesh exposure.Describe any medical/surgical intervention for exposure including dates and surgical findings.(b)(6) 2015 excision mesh exposure for 4mm anterior mesh exposure; (b)(6) 2020 ¿ surgical excision mesh exposure for 1.5cm mesh exposure.Which mesh type was removed during excision? total prolift.What is physician¿s opinion as to the etiology of or contributing factors to this event? n/a.What is the patient's current status? bleeding settled.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Adverse event regarding tvt-o mesh submitted via 2210968-2020-09162.Adverse event regarding prolift mesh submitted via 2210968-2020-09163.Adverse event regarding tvt mesh submitted via 2210968-2020-09164.Adverse event regarding partial excision of prolift mesh submitted via 2210968-2021-00592.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GYNECARE TVT W/PRLNE BLUE MESH 1 EACH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10877382
• MDR Text Key: 217463472
• Report Number: 2210968-2020-09164
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: 810041B
• Device Lot Number: 3135641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR