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

Model Number Y100

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Exposure to Body Fluids (1745); Memory Loss/Impairment (1958); Pain (1994); Sjogren's Syndrome (2073); Urinary Tract Infection (2120); Dysuria (2684); Patient Problem/Medical Problem (2688); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient was diagnosed with cancer, sjogren¿s syndrome, and several utis after implantation of the alyte y-mesh graft.The patient also reportedly developed memory loss, pain during sex, pain during urination, sensitivity to hot and cold, and "brain fog".The patient was seen by several physicians; treatment provided is unknown.

Event Description

It was reported that the patient was diagnosed with cancer, sjogren¿s syndrome, and several utis after implantation of the alyte y-mesh graft.The patient also reportedly developed memory loss, pain during sex, pain during urination, sensitivity to hot and cold, and "brain fog".The patient was seen by several physicians; treatment provided is unknown.

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.A potential root cause of the reported event could be that the patient was not assessed for suitability and was not a good candidate for this surgery, either because the physician did not know to check a patient for suitability, or the physician did not know what makes a patient suitable for procedure.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "instructions for use caution: federal (usa) law restricts this device to sale by or on the order of a physician.The alyte® y-mesh graft is intended for use only by physicians who are trained in the surgical procedures and techniques required for pelvic floor reconstruction (including abdominal sacrocolposuspension / sacrocolpopexy) and the implantation of non-absorbable meshes.The physician is advised to consult the medical literature regarding techniques, complications, and hazards associated with the intended procedures.Description the alyte® y-mesh graft utilizes a variable knit lightweight/ultra-lightweight non-absorbable monofilament polypropylene mesh.The y-mesh configuration is designed such that the surgeon will be able to alter/trim the graft to different sizes as required to fit each patient¿s anatomical requirements without unraveling.Indications for use the alyte® y-mesh graft is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.Contraindications the use of the alyte® y-mesh graft is contraindicated for patients who are pregnant or may become pregnant, or those with a systemic infection or infection in the operative field.Warnings: the effectiveness of this product has not been validated by a prospective randomized clinical trial the implant procedure carries an inherent risk of infection and bleeding, as do similar urological procedures.After use, the product and its packaging should be treated as a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.Precautions.Based on physician experience and training, a thorough assessment of each patient should be made to determine their suitability for a synthetic mesh procedure.Additional consideration should be given to the use of alyte® y-mesh graft in patients with a compromised immune system, any condition that would compromise healing, or any patient with a history of prior abdominal or pelvic surgeries.Consideration should also be given to the ability of the patient to tolerate the surgical procedure.Accepted surgical practice and precautions must be followed for the management of infected or contaminated wounds.Postoperative bleeding may occur in some patients and must be controlled prior to patient release.Sutures should not be placed in the mesh edge.Sutures should be placed a minimum of 1cm from any mesh edge.Inadequate suturing of the graft material to the pelvic tissues may lead to failure of the repair, additional complications and recurrence of prolapse.Check the integrity of the packaging before use.Do not use the mesh if the packaging is opened or damaged.As for any implantable material, it is recommended to open the package at the time of implantation.The alyte® y-mesh graft is intended as a single-use device.Do not re-sterilize any portion of the alyte® y-mesh graft.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Post-operatively the patient should be advised to refrain from heavy lifting, exercise (e.G.Cycling, jogging) and/or intercourse until the physician determines it is suitable for the patient to return to normal activities.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)." h11:section a through f - the information provided by bd 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 bd.The device was not returned.

• Brand Name: ALYTE¿ Y-MESH GRAFT
• Type of Device: ALYTE Y-MESH GRAFT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8568466
• MDR Text Key: 143670841
• Report Number: 1018233-2019-02248
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 00801741016158
• UDI-Public: (01)00801741016158
• Combination Product (y/n): N
• PMA/PMN Number: K101722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2017
• Device Model Number: Y100
• Device Catalogue Number: Y100
• Device Lot Number: HUZH0349
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention