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

Catalog Number	Y100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Injury (2348); Prolapse (2475)
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: "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 recurrent vaginitis, vulvovaginitis, candidiasis, vaginal vault prolapse, continued pessary use, urinary tract infection, bacterial vaginosis, frequency, urgency, pelvic pain, abdominal pain, vaginal discharge, depression, prolapsed omentum secondary to vaginal wall defect (vaginal cuff dehiscence with omentum in the vagina), omentectomy, pain and pressure with bloating in the upper abdominal area, cystocele, rectocele, apical prolapse, dehiscence of internal surgical wound, incompetence of pubocervical tissue, female proctocele, mixed incontinence, adhesions, exposure of vaginal mesh, vaginal bulging, pain and pressure in vaginal/rectal area, inability to ambulate for more than a few minutes due to weakness and discomfort, pulling sensation back of vagina/rectum, dyspareunia, exposure of prolene suture, and removal of exposed suture.She has required multiple surgical and non-surgical interventions.

• 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: 9788425
• Report Number: 1018233-2020-01545
• Device Sequence Number: 13593060
• Product Code: OTO
• UDI-Device Identifier: 00801741016158
• UDI-Public: (01)00801741016158
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/04/2020

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: 02/28/2014
• Device Catalogue Number: Y100
• Device Lot Number: HUVL1214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/04/2020
• 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: 47 YR
• Patient Weight: 73