MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) TEGRESS URETHRAL IMPLANT

Catalog Number 653001

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

Patient Problems Incontinence (1928); Septic Shock (2068); Urinary Tract Infection (2120)

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 recurrent/worsening/significant stress urinary incontinence (sui), urge incontinence, unconscious incontinence, recurrent urinary tract infections (utis), polyneuritis with urosepsis ((b)(6) 2006), urethral insufficiency, grade 2 bladder neck hypermobility, grade 2 rectocele, trouble passing bowels/constipation, vaginal dryness, large infected bartholin's cyst (required incision and drainage; (b)(6) 2008), fecal soiling, cyst in left kidney (causing narrowed ureteropelvic junction with mild hydronephrosis), nephrolithiasis in right kidney (non-obstructive), renal artery stenosis (stents placed; (b)(6) 2011 )."recurrence of incontinence (must wear pads), recurrent utis, septic shock, leakage, loss of consortium (spouse filed claim), and mental and/or emotional damages (depression, due to incontinence, multiple surgeries, frustration from on improvement.Must wear pads).".

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 egress' 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=l74) 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 {i1%) urge incontinence 16 ( 9%) worsening of incontinence (onset of urge) 14 ( 8%) outlet obstruction l3 ( 7%) pain at injection site 13 ( 7%) pelvic pain l3 ( 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) 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.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 (lsd).Control patients were treated with a commercially available absorbable bulking agent.Patients were adult women diagnosed as having stress urinary incontinence due to lsd.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.

• Brand Name: TEGRESS URETHRAL IMPLANT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON); covington GA
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON); 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4112906
• MDR Text Key: 4924718
• Report Number: 1018233-2014-00237
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/31/2008
• Device Catalogue Number: 653001
• Device Lot Number: 0502A011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 12 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2005
• 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
• Treatment: PELVISOFT ACELLULAR OLLAGEN BIOMESH
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR