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

Catalog Number 810041B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Retention (2119); Urinary Tract Infection (2120)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Additional information was requested and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure - 59 year old female, 254lbs, bmi 43.6.*date and name of index surgical procedure? - (b)(6) 2023 - retropubic midurethral sling; cystourethroscopy.*the diagnosis and indication for the index surgical procedure? - stress urinary incontinence; urethral hypermobility.*were any concomitant procedures performed? - no.*what symptoms did the patient experience following the index surgical procedure? onset date? - 10/19/23 ¿ developed urinary frequency and burning with urination.*other relevant patient history/concomitant medications? - morbid obesity ¿ wygovy *please describe any medical intervention required to treat the urinary tract infection including medication name and results - 10/20/23- macrobid 100mg twice daily ordered; urine culture (10/20/23) ¿ negative for infection; macrobid discontinued.*please provide the date and surgical findings of any reoperation performed.- (b)(6) 2023 ¿ revision of sling; urethrolysis; cystourethroscopy - findings: rolled up sling mesh on anterior vaginal wall was incised.Intraoperative cystourethroscopy revealed normal bladder mucosa throughout.No evidence of cystotomy, sutures, lacerations, lesions, or mesh.There was normal efflux of urine from bilateral ureteral orifices.Normal urethra.*during reoperation, was the implanted device adjusted, cut or removed? - the vaginal mucosa was dissected free from the underlying sling.Mesh was also dissected carefully from underlying bladder and urethra.Sling was incised resulting in immediate lack of tension on urethra.*what is the physician¿s opinion as to the etiology of or contributing factors to this event? - sling was tensioned too tightly during surgery.*what is the patient's current status? - 11/20/23 ¿ follow-up clinic visit: pt.Experiencing urge incontinence; no stress incontinence noted.- urinalysis ¿ negative; pvr ¿ within normal limits.- trial of mirabegron and bladder retraining with crnp.Follow-up in 4 months.*product code and lot number? - mesh tvt dev w/blu model# 810041b lot# 3943465 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.H6 component code: g07002 ¿ device not returned.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2023 and mesh was implanted.On (b)(6) 2023, a moderate urinary tract infection was noted.The patient was given macrobid 100mg twice daily.Urine culture on (b)(6) 2023 was negative for infection and the macrobid was discontinued.The uti was recovered/resolved without sequelae as of 25-oct-2023.This event was reported to have a probable relationship with the study device and study procedure.On (b)(6) 2023, severe difficulty voiding was noted.On (b)(6) 2023, the patient underwent revision of sling, urethrolysis and cystourethroscopy.The vaginal mucosa was dissected free from the underlying sling.Mesh was also dissected carefully from underlying bladder and urethra.Sling was incised resulting in immediate lack of tension on urethra.The difficulty voiding was recovered/resolved without sequelae as of 20-nov-2023.This event was reported as having a causal relationship with the study device and study procedure.The surgeon opined that the sling was tensioned too tightly during surgery.Additional information was requested.

Manufacturer Narrative

(b)(4).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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• Brand Name: GYNECARE TVT W/PRLNE BLUE MESH 1 EACH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18348957
• MDR Text Key: 330814946
• Report Number: 2210968-2023-09877
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 810041B
• Device Lot Number: 3943465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 115 KG