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

Model Number Y500

Device Problems Break (1069); Corroded (1131); Degraded (1153); Material Twisted/Bent (2981)

Patient Problems Abdominal Pain (1685); Fainting (1847); Fatigue (1849); Inflammation (1932); Irritation (1941); Muscle Spasm(s) (1966); Pain (1994); Rash (2033); Respiratory Distress (2045); Burning Sensation (2146); Tingling (2171); Urticaria (2278); Reaction (2414); Ambulation Difficulties (2544); Abdominal Distention (2601); Constipation (3274)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported by the patient that the device corroded, broken into bits, degrading, was twisted and kinked and allegedly too tight.The patient alleged that due to the mesh implant, she has experienced chronic pain, the inability to sit, squat, drive, walk and bend.She has experienced pain in her back, hip, buttocks, legs, knees, waist, pelvis, inside of the vagina, the abdomen area, the stomach, and during urination.The patient also stated that she has experienced a burning feeling and vibrations in the knees, loss of strength, fatigue, stomach / abdomen spasms, bloating, tingling in the arms, urticarial hives, dry mouth, loose bowels, constipation, puffy eyes, shortness of breath, and panic attacks with ptsd.The patient also noted that she has passed out / fainted at work, and there been inflammation of the main blood vessels and arteries due to a reaction of the degradation of the device.The patient stated that she takes 2.5 ml of morphine four times a day to help with the pain.She has also taken naproxen, gabapentin, pregabalin, capsaicin cream, tramadol, co-codamol, ibuprofen gel, and piriton syrup.This event involves the same patient and the same device, but has multiple alleged failures which require multiple reports.This is report two of five.

Manufacturer Narrative

The reported event was inconclusive.Only a photo sample was received for evaluation.The evaluation of the diagnostic image provided by the complainant was inconclusive for the reported event.Medical affairs provided a clinical assessment.The assessment concluded that the reported event could not be confirmed using the image.It was very difficult to use the image alone as a method to evaluate the reported event.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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 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 fi t each patient¿s anatomical requirements without unraveling.Indications for use the alyte¿ y-mesh graft is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse including, but not limited to sacrocolposuspension where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.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 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 ¿ the alyte¿ y-mesh graft has not been evaluated in human subjects for the treatment of vaginal wall prolapse.¿ 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).".

Event Description

It was reported by the patient that the device corroded, broken into bits, degrading, was twisted and kinked and allegedly too tight.The patient alleged that due to the mesh implant, she has experienced chronic pain, the inability to sit, squat, drive, walk and bend.She has experienced pain in her back, hip, buttocks, legs, knees, waist, pelvis, inside of the vagina, the abdomen area, the stomach, and during urination.The patient also stated that she has experienced a burning feeling and vibrations in the knees, loss of strength, fatigue, stomach / abdomen spams, bloating, tingling in the arms, urticarial hives, dry mouth, loose bowels, constipation, puffy eyes, shortness of breath, and panic attacks with ptsd.The patient also noted that she has passed out / fainted at work, and there been inflammation of the main blood vessels and arteries due to a reaction of the degradation of the device.The patient stated that she takes 2.5ml of morphine four times a day to help with the pain.She has also taken naproxen, gabapentin, pregablin, capsacrin cream, tramadol, co-dodamol, ibuprofen gel, and piriton syrup.This event involves the same patient and the same device, but has multiple alleged failures which require multiple reports.This is report two of five.Per additional information, the device was allegedly implanted in (b)(6) 2014.

• 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: 8012042
• MDR Text Key: 125439753
• Report Number: 1018233-2018-04998
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 00801741016165
• UDI-Public: (01)00801741016165
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Y500
• Device Catalogue Number: Y500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1