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

Model Number	Y100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Incontinence (1928); Pain (1994); Perforation of Vessels (2135); Prolapse (2475); Fibrosis (3167)
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
It was reported by the patient's attorney that as a result of having the product implanted the patient had experienced chronic back pain, prolapse but that there was no visible or palpable eroded mesh.Patient was also suffering from pain in the lower back and shooting pain towards the umbilicus.Patient was suffering from severe back pain and generalized pelvic pain since surgery.It was also noted that the patient was experiencing postmenopausal bleeding and some postcoital bleeding, vaginal bleeding, difficulty fully evacuating her bowels, and symptoms of urgency and stress incontinence.It was concluded that the mesh implanted within the patient had bunched up behind her bladder and that the end of a connecting suture had perforated the bladder just above the trigone.Patient had developed marked fibrosis and tethering of the vagina, bladder and right pelvic side bone.The patient elected to proceed with minimal access surgery and laser treatment of the bladder.Owing to the onset of the covid-19 pandemic, the patient had not yet undergone this procedure.The patient continued to endure pain and suffering as a result of the implantation of the mesh device manufactured and supplied by the defenders.

• 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: 12353454
• Report Number: 1018233-2021-80062
• Device Sequence Number: 11659038
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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: 11/28/2016
• Device Model Number: Y100
• Device Catalogue Number: Y100
• Device Lot Number: HUYK0951
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/23/2021
• 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