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

Model Number	Y100
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Abdominal Pain (1685); Death (1802); Injury (2348)
Date of Event	09/25/2013
Type of Reportable Event	Death
Additional Manufacturer Narrative
The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.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 and urinary incontinence (stress and urge).'' (b)(4).
Event or Problem Description
It was reported by the patient's attorney that the patient had an alyte y mesh device implanted on (b)(6) 2013 during an abdominal colposacropexy procedure for vaginal vault prolapse.Following surgery in (b)(6) 2013, the patient experienced abdominal pain and urinary incontinence.Beginning in (b)(6) 2017, the patient experienced urinary leakage and contacted general physician who referred the patient to a urogynaecologist.In (b)(6) 2017, a cystoscope revealed that the mesh had eroded into the patient¿s vagina and developed a vesicovaginal fistula.In (b)(6) 2018, the patient underwent a laser procedure to remove the mesh that had perforated the patient's bowel.The procedure did not remove all of the eroded mesh from the patient.The patient experienced pain, discomfort, and chronic inflammation of the pelvis.It was also reported that the patient expired on (b)(6) 2018.The cause of death listed on the death certificate was multiple organ failure, anterior rectal perforation, chronic pelvic inflammation with possible sepsis, and sacrocolpopexy mesh repair.

• 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: 10200037
• Report Number: 1018233-2020-04112
• Device Sequence Number: 16703003
• Product Code: OTO
• UDI-Device Identifier: 00801741016158
• UDI-Public: (01)00801741016158
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Y100
• Device Catalogue Number: Y100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/26/2020
• 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: Death; Required Intervention
• Patient Age: 70 YR