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 Bacterial Infection (1735); Chills (2191); Syncope/Fainting (4411)

Event Date 12/06/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2023 and mesh was implanted.On 06-dec-2023, the patient experienced a moderate syncopal episode, resulting in a er visit.The patient received iv fluids and the event was recovered/resolved without sequelae the same day.On 08-dec-2023, the patient experienced a moderate fainting spell.Ct scan and labs were performed, along with follow-up with neurologist.This event was recovered/resolved without sequelae the same day.On 12-dec-2023, the patient experienced severe r/o bacteremia.Ctap, blood cultures and urine cultures were performed and the event was recovered/resolved without sequelae as of 13-dec-2023.These events were all reported as not related to the study device, but possibly related to the study procedure.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.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? please describe the patient manifestations of the reported bacteremia (location, severity, appearance, systemic or local infection).Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.Please describe any medical intervention performed including medication name and results.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? facility name? 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.

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: h6 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.Additional information was requested and the following was obtained: please provide the patient's demographic information including gender, weight, bmi at the time of index procedure - female, wt 124 lbs, bmi 20.63kg name of index surgical procedure? - retropubic midurethral sling the diagnosis and indication for the index surgical procedure? - stress urinary incontinence were any concomitant procedures performed? - vaginal repair of enterocele; posterior repair with perineorrhaphy; cystourethroscopy other relevant patient history/concomitant medications? - (b)(6) 2017 - supracervical hysterectomy; abdominal sacrocolpopexy; repair bladder injury.Please describe the patient manifestations of the reported bacteremia (location, severity, appearance, systemic or local infection).- pt complained of chills, syncopal episode.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? - no did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.- no prophylactic antibiotics.- (b)(6) 2023 blood culture (non study hospital emergency room) ¿ results: gm positive, reported to patient (b)(6) 2023.(b)(6) 2023 blood culture (hup) ¿ results: no growth please describe any medical intervention performed including medication name and results.- on (b)(6) 2023, the patient had a syncopal episode after urinating.She went to the emergency room (non-study facility), received ivf, felt better, and was discharged.- on (b)(6) 2023, she experienced multiple pre-syncopal episodes and slowed speech.She went to the er (non-study facility) where workup including labs and ct scan, were benign, and did not show evidence of sepsis or bowel injury.- on (b)(6) 2023, post-op visit by study surgeon - patient said overall she was feeling well but still reported subjective chills and feeling "off".- on (b)(6) 2023, patient notified that her blood culture (ordered 12/8 emergency room visit) was positive: gm positive cocci.Patient contacted the study surgeon who recommended direct admission to the hospital for evaluation.On presentation, patient feeling better.Some chills over the past few days but had not taken her temperature.She denies abdominal pain, nausea/vomiting since surgery.Passing flatus and has had multiple bms since surgery, soft mostly formed.Some discomfort in her vagina/pelvis postop, but no sharp pain and no vaginal bleeding.Vss and exam, within normal limits; follow-up blood and urine cultures ¿ negative.Ct abdomen and pelvis: no evidence of acute abdominopelvic process.(b)(6) 2023, patient discharged to home.- follow-up with neurologist recommended.What is the physician¿s opinion as to the etiology of or contributing factors to this event? - final diagnosis was postoperative fatigue and anxiety.What is the patient's current status? - (b)(6) 2024 ¿ office visit with study surgeon: no fever, chills, discharge, eating well.Complained of discomfort from perineal stitch.Vicryl stitch on perineum in midline at site of perineorrhaphy was removed easily during exam.No mesh exposure.Pin point opening at bottom of stitch, no discharge.Patient reassured that pin point opening will heal spontaneously.Follow-up in 2 months.Product code and lot number? - model/catelog# 810041b.- lot# 3929038.

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: 18454605
• MDR Text Key: 332260002
• Report Number: 2210968-2024-00135
• 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,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 3944396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 56 KG