MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problems Material Erosion (1214); Defective Component (2292)

Patient Problems Erosion (1750); Fever (1858); Fistula (1862); Unspecified Infection (1930); Urinary Tract Infection (2120); Injury (2348); Not Applicable (3189)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 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.Date and name of initial surgical 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.Product code and lot number? what is physician¿s opinion as to the etiology of or contributing factors to this event? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the fistula first noted by a physician? when was the mesh exposure first noted by a physician? mesh exposure symptoms and diagnostic confirmation? describe medical/surgical intervention for exposure including dates and findings.What is the patient's current status?.

Event Description

It was reported that the patient underwent gynecological procedure on an unknown date and mesh was implanted.Sub urethral fascial sling was inserted for urinary stress incontinence and to cover defect.Following the procedure, the patient underwent removal of eroded mesh by vaginal and abdominal approach.It was reported that the mesh already breached as previously attempted laser removal elsewhere.The mesh cheesewired through urethra to lie dorsally.The lasered portion fistulated through urethra to cause urethra-vaginal fistula.The patient experienced an uncomplicated bowel injury from insertion of suprapubic catheter and it was repaired.The patient was pyrexial and peritonitic post-op.The patient underwent exploratory laparotomy to exclude faecal peritonitis and underwent washout only.It was reported that an upper respiratory tract infection was cause of sepsis and decreased saturations and patient was temporarily ventilated on itu.The patient returned to ward for physio and further recovery.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 02/09/2018.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Additional patient code: (b)(4).Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure age (b)(6).Weights known.Bmi 25-30.Lifelong smoker date and name of initial surgical procedure unknown but at least 2 years ago at another hospital trust.Tvt the diagnosis and indication for the initial surgical procedure? presume stress incontinence what is physician¿s opinion as to the etiology of or contributing factors to this event? possibly tape placed too distally and too tight laser procedure the initial approach for the index surgical procedure? standard any concurrent procedure/device implantation? no were there any intra-operative complications? none documented when was the fistula first noted by a physician? (b)(6) 2018 when was the mesh exposure first noted by a physician? (b)(6) 2017 mesh exposure symptoms and diagnostic confirmation? pain and recurrent uti hospital cystoscope the patient 18 months ago and there was no evidence of mesh erosion then.Pain and recurrent uti seen on flexible cystoscopy describe medical/surgical intervention for exposure including dates and findings.Urologist attempted to remove mesh by laser (b)(6) 2017 patient referred to physician as she was still wet physician performed cystoscope the patient and found remnants of the mesh what is the patient's current status? unknown.Patient due for usual follow up appointment in clinic early april.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON SARL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7259983
• MDR Text Key: 99598968
• Report Number: 2210968-2018-70774
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 01/19/2018; 02/16/2018
• Supplement Dates FDA Received: 02/09/2018; 02/20/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR