MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALYTE Y-MESH GRAFT

Model Number	Y500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Injury (2348); Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
Additional 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: ¿complications associated with the proper implantation of the alyte® y-mesh graft may include, but are not limited to those typically associated with surgically implantable materials including: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, or any viscera, which may occur during the implantation procedure.Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.Extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.Urinary incontinence (stress and urge)." (b)(4).
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.Per additional information received, the patient has experienced mesh exposure from the total prolift and tvt, vaginal pain, bloody brown vaginal discharge, dyspareunia, vaginal odor, difficulty voiding, vaginal wall prolapse, old laceration of muscles of pelvic floor, urinary retention, abdominal pain, constipation, diarrhea, incomplete emptying, nocturia, frequency, stress and urge incontinence, kink of urethral meatus, attenuated perineum, vaginal scarring, anterior mesh exposure, hypermobile bladder neck, cords of mesh, foreign body in vagina-exposed mesh, severe scarring in every space and segment of the pelvic floor, anteriorly, posteriorly, laterally as well as under the urethra, eroded sling mesh, per pathology-synthetic mesh material with chronic inflammation, foreign-body giant cell reaction, and fibrosis, with focal acute inflammation, surgical and nonsurgical interventions including, bilateral paravaginal dissection, bilateral pararectal dissection, removal of prolift mesh, sling revision and urethral lysis, removal of mesh from the obturator internus muscles, anterior colporrhaphy, posterior colporrhaphy, colpoperineorrhaphy on (b)(6) 2015, and silver nitrate application to posterior granulation tissue of the vagina on (b)(6) 2016.The patient also experienced bowel obstruction and perforation, collagen disorder and deficiency, connective tissue disorder, fistula, hernia, vaginal or bladder infections, and wound healing problems.

• Brand Name: ALYTE Y-MESH GRAFT
• Common Device Name: ALYTE Y-MESH GRAFT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9241613
• Report Number: 1018233-2019-06812
• Device Sequence Number: 160766
• Product Code: OTO
• UDI-Device Identifier: 00801741016165
• UDI-Public: (01)00801741016165
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: Y500
• Device Catalogue Number: Y500
• Device Lot Number: HUVJ1759
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 83