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

Catalog Number 653001

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Incontinence (1928); 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 stress urinary incontinence, pain in right lower pelvic area (possibly behind the obturator fossa), pain in bilateral groin area around the area of scars from the tot, inguinal pain from prior hernia repair, candidiasis of vulva/vagina, urinary tract infection, hematuria, cystocele, recurrent urethrocele, postmenopausal atrophic vaginitis, urinary frequency, other nonspecific findings on examination of urine, suburethral mesh migrated distally near urethral opening, no support of urethrovesical junction."old dissolving mesh material was encountered at the distal portion of the incision, near the urethral opening." "fragments of fibrous tissue with deposits of amorphous debris surrounded by histiocytes and multinucleated giant cells," unspecified pain, erosion, unspecified infection, unspecified urinary problems, "recurrence," dyspareunia, and loss of consortium.Subsequently underwent trigger point injection with marcaine and steroids (06/10/2008), mesh revision with removal of a central portion of the old mesh, and mesh placement with mini-arc precise transobturator tape mesh and cystoscopy ((b)(6) 2012).

Manufacturer Narrative

The investigation is in progress.Once the investigation is complete, a follow up supplemental report will be mailed.

Manufacturer Narrative

The sample was not returned.The finished product met all specs prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically unplanted materials.The instructions for use states in the adverse events: observed adverse events.The tegress urethral implant clinical trial involved 374 regress implant treatment injections in 174 subjects (mean f/u of approx 14 months).There were no deaths among study pts.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 other 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 membrane 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 (na).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 material adverse events included: bladder spasms, bladder stones, bulking 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 tegresstm implant patients treated periurethrally; as a result, the tegresstm 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 tegresstm 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, pathology, confounding bladder 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.".

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.

Manufacturer Narrative

(b)(4).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.

Event Description

Per additional information received, the patient has experienced blood loss.

• Brand Name: BARD 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: 4360260
• MDR Text Key: 5116672
• Report Number: 1018233-2014-00363
• 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,Followup
• Report Date: 08/24/2016

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: 03/31/2009
• Device Catalogue Number: 653001
• Device Lot Number: 43CQH001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/30/2014; 07/20/2016; 08/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2006
• 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: 66 YR
• Patient Weight: 69