MAUDE Adverse Event Report: BARD SHANNON LIMITED -3005636544 TEGRESS URETHRAL IMPLANT

Catalog Number 653001

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

Patient Problems Pain (1994); Urinary Tract Infection (2120); Blood Loss (2597)

Event Type  Injury  

Event Description

It was reported in the patient's medical records that as a result of having the product implanted, the patient has experienced abdominal pain, pelvic pain, vaginal discharge, hospitalization for intravenous antibiotic therapy, vaginal erosion of mesh requiring excision of exposed mesh and repair of vaginal erosion, urinary tract infection, anterior vaginal wall scar tissue, point tenderness of the left fornix, vaginal discomfort, stress urinary incontinence, exposed sling mesh, open vaginal wound and dyspareunia requiring removal of transobturator tape sling, constipation, left pelvic pain extending down leg, spotting, and left groin pain, from extrusion, bleeding and neuromuscular problems.

Manufacturer Narrative

The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.Potential adverse events: although not reported in the clinical study, other potential adverse events which may occur include erosion, erythema, embolic phenomena, and vascular occlusion.Clinical studies: purpose and design of the tegress urethral implant clinical study: a randomized, masked, multicenter clinical investigation was performed to evaluate the safety and effectiveness of tegress implant for the treatment of stress urinary incontinence due to intrinsic sphincter deficiency (isd).Control patients were treated with a commercially available absorbable bulking agent.Patients were adult women diagnosed as having stress urinary incontinence due to isd.To be eligible for enrollment, subjects were required to have a viable mucosal lining at the injection site and normal bladder capacity.Subjects with uncontrolled bladder instability, high post-void residual urine volume, uterine prolapse greater than stage ii, confounding bladder pathology, uti, and morbid obesity were excluded.Following enrollment, patients were randomized 2:1 between tegress implant and control.A maximum of three treatments were permitted over a period of 90 days from initial treatment, and results were assessed versus baseline at 3, 6 and 12 months from final treatment.Treatment results are reported for all subjects who received treatment.(b)(4).

Manufacturer Narrative

The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: observed adverse events: the tegress¿ urethral implant clinical trial involved 374 tegress¿ implant treatment injections in 174 subjects (mean follow-up of approximately 14 months).There were no deaths among study patients.The following table lists the treatment related adverse events reported during the clinical study (incidence >2%).Treatment related events are those events that were deemed to be related to either the device or the procedure.All genitourinary events were classified as treatment related.Number (%) subjects reporting treatment related adverse events event category tegress¿ implant (n=174), urinary tract infection (uti) 50 (29%), delayed voiding 32 (18%), dysuria 31 (18%), exposed material 28 (16%), urinary urgency 24 (14%), urinary frequency 22 (13%), genitourinary (infection, tenderness) 20 (11%), hematuria 19 (11%), urge incontinence 16 ( 9%), worsening of incontinence (onset of urge) 14 ( 8%), outlet obstruction 13 ( 7%), pain at injection site 13 ( 7%), pelvic pain 13 ( 7%), yeast infection 12 ( 7%), leakage of urine/stress incontinence 9 ( 5%), bulking material injected into bladder 7 ( 4%), fatigue 3 ( 2%), abnormal urinalysis 3 ( 2%), bladder fullness 3 ( 2%), nocturia 3 ( 2%), pelvic heaviness 3 ( 2%), uterine fibroids 3 ( 2%), other (<2%) 38 (n/a).Other treatment related adverse events in tegress¿ urethral implant patients, occurring at frequencies of < 2%, were as follows (listed alphabetically): abdominal upset, bladder spasms, bladder stones, body aches, burning pain, cold and shivering, cyst, cystitis, feeling of decreased sensation with urination, feeling of bladder not emptying, felt faint during bulking injection, fever, garlic odor, genital pain, kidney stones, labia with erythema, lower back pain, medicinal smell to urine, nausea, partial urinary retention due to dementia, pyuria, removal of tegress¿ implant, urethral burning sensation, urethral irritation, urethral redness, urethral soreness, urethral spasm, vaginal bleeding, and vulvar burning.Most treatment related adverse events occurred within 24 hours of treatment and subsequently resolved within 30 days.At the time of database closure, 92% of treatment related adverse events were resolved.The following events were persistent or resolution was unconfirmed at the time of database closure (the number of events is shown in parentheses): urge incontinence (6); leakage of urine/stress incontinence (5); worsening of incontinence (onset of urge) (5); exposed material (4); uterine fibroids (3); urinary tract infection (2); urinary frequency (2); urinary urgency (2) and one event each of genitourinary (infection/tenderness), kidney stones, nocturia, pelvic pain, urethral redness, and tegress¿ implant removal.Of the treatment related adverse events, 39% were classified as mild, 58% were classified as moderate, and 3% were classified as severe.The severe treatment related adverse events included: bladder spasms, bladder stones, bulking material injected into the bladder, delayed voiding, exposed bulking material, hematuria, pelvic pain, urge incontinence, and urinary frequency.The clinical study consisted of a pilot or feasibility phase (n=28), followed by the expanded study phase (n=146).There was higher overall rate of genitourinary adverse events in the feasibility phase of the study than in the expanded phase.In particular, the rate of ¿exposed material¿ was higher (32% vs.13%).This reduction in the rate of exposed material was achieved as a result of modifications to the tegress¿ implant injection instructions and investigator training.During the course of the clinical investigation (both study phases), 28 subjects (16%) receiving tegress¿ urethral implant treatment experienced exposed bulking material in the urethral mucosa.Patients experiencing exposed material often reported other events, particularly dysuria, delayed voiding, urinary tract infection, hematuria, urinary frequency, and urinary urgency.Exposed tegress¿ implant material was associated with shallow placement and injection too proximal to the bladder neck.Over time, the urethra healed spontaneously as the mucosal surface re-epithelialized.The physician may choose to remove exposed material cystoscopically with graspers or forceps to facilitate healing.The majority of patients were injected via the transurethral approach, while a small proportion of patients were injected periurethrally.There were significantly more adverse events among tegress¿ implant patients treated periurethrally; as a result, the tegress¿ urethral implant instructions for use are limited to transurethral administration.Potential adverse events: although not reported in the clinical study, other potential adverse events which may occur include erosion, erythema, embolic phenomena, and vascular occlusion.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: TEGRESS URETHRAL IMPLANT
• Manufacturer (Section D): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 4252733
• MDR Text Key: 18727040
• Report Number: 1018233-2014-00299
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030030 S005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2016

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: Health Professional
• Device Expiration Date: 11/30/2008
• Device Catalogue Number: 653001
• Device Lot Number: 43KPH001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 11/05/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/26/2016; 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2005
• 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: 43 YR