MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT-ABBREVO MINI LCM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTOML

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

Patient Problem Urinary Retention (2119)

Event Date 04/26/2023

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.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.Please provide the patient's demographic information including gender, weight, bmi at the time of index procedure name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? other relevant patient history/concomitant medications? how was the urinary retention confirmed? please describe any medical intervention required to treat the urinary retention including medication name and results.Please provide the date and surgical findings of any reoperation performed.Does the surgeon believe the urinary retention is functional or structural in nature? a.Functional: the local surgical trauma and the anesthetics in combination with other patient related issues b.Structural: if a pelvic mesh or sub-urethral sling was physically obstructed the urinary tract at the levels of ureters or urethra what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? country of event? product code and lot number? 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 the same day as the procedure, the patient experienced mild urinary retention.A urinary catheter was inserted and the event was recovered/resolved without sequelae, also on (b)(6) 2023.This event was reported as having a probable relationship with the study device.Additional information has been 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.Additional information was requested and the following was obtained: please provide the patient's demographic information including gender- female, weight, bmi at the time of index procedure female 55 kg, 168 cm, bmi 19,5 kg/m2 name of index surgical procedure? tvt-abbrevo the diagnosis and indication for the index surgical procedure? incontinenza urodinamica da sforzo di grado severo were any concomitant procedures performed? no other relevant patient history/concomitant medications? nifedipin 20 mg cpr ret [cpr] 1-0-0-0 per os losartan axapharm cpr rivestite 100 mg 0-0-1-0 betaserc 8 mg cpr [cpr] 0-0-0-0 in riserva: in riserva se vertigini magnesium diasporal 300 mg gran sacc [sacc] 1-0--0 per os 3/settimana vitamine d3 streuli 4000 ui/ml pour thérapie solution buvable 0-0-0-0 1/settimana vitamina b12 0-0-0-0 ogni 3 mesi calcium d3 sandoz 1000/880 polv orale sacc [sacc] 1-0-0-0 alendronat sandoz cpr rivestite 70 mg 0-0-0-0 1/settimana how was the urinary retention confirmed? by ultrasound, measuering bladder volume after voiding please describe any medical intervention required to treat the urinary retention including medication name and results.Urinay catheter please provide the date and surgical findings of any reoperation performed.No reoperation does the surgeon believe the urinary retention is functional or structural in nature? functional a.Functional: the local surgical trauma and the anesthetics in combination with other patient related issues b.Structural: if a pelvic mesh or sub-urethral sling was physically obstructed the urinary tract at the levels of ureters or urethra what is the physician¿s opinion as to the etiology of or contributing factors to this event? it could be related to the surgical trauma (denervation?) what is the patient's current status? completely recovered country of event? switzerland.Product code and lot number? tvt oml lot 3942981.

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.

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.Updated information received: if event is serious and device related (unlikely, possible, probable, or causal relationship), according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : no => n/a.Relationship to primary study procedure : blank => unlikely.If event is serious and device related (unlikely, possible, probable, or causal relationship), according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : n/a => no.

• Brand Name: GYNECARE TVT-ABBREVO MINI LCM
• 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: 17961330
• MDR Text Key: 325986370
• Report Number: 2210968-2023-07976
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062368
• UDI-Public: 10705031062368
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K100936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: TVTOML
• Device Lot Number: 3942981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 55 KG