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

Catalog Number	Y100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Anemia (1706); Aneurysm (1708); Arrhythmia (1721); Bacterial Infection (1735); Erosion (1750); Stroke/CVA (1770); Diarrhea (1811); Fatigue (1849); Micturition Urgency (1871); Headache (1880); Hemorrhage/Blood Loss/Bleeding (1888); Muscle Weakness/Atrophy (1967); Nausea (1970); Pain (1994); Sepsis (2067); Septic Shock (2068); Transient Ischemic Attack (2109); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vertigo (2134); Visual Impairment (2138); Dizziness (2194); Hernia (2240); Peritonitis (2252); Urinary Frequency / Polyuria (2275); Discomfort (2330); Depression (2361); Obstruction/Occlusion (2422); Prolapse (2475); Shaking/Tremors (2515); Abdominal Distention (2601); Osteopenia/ Osteoporosis (2651); Dysuria (2684); Syncope/Fainting (4411); Tricuspid Valve Insufficiency/ Regurgitation (4453); Gastrointestinal Regurgitation (4477); Genital Bleeding (4507); Vertebral Fracture (4520); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, suffering, disability, impairment.
Additional Manufacturer Narrative
The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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)." 1994 = "l".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.H3 other text: the device was not returned.
Event or Problem Description
It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, suffering, disability, impairment.As per additional information received via medical records on 15nov2023 the patient had experienced increased abdominal pain post-surgical complications following vaginal prolapse repair, acute vaginitis, atrophy of the vagina, septic shock, vaginal bleeding, severe general pain, migraines, odorous dark-brown discharge, depression, back pain, frequent urge to urinate, abnormal discharge, bacterial infection, vision issues, sepsis, headache, terrible left eye glare, stroke, develops episodes of tremors and lightheadedness, shortness of breath syncope, dizziness, urinary tract infection, transient ischemic attack tia.Chronic thoracic compression deformities, dyslipidemia, osteoporosis, tricuspid valve regurgitation, palpitations, chest pressure, wheezes, anemia, vertigo, ataxia, age related osteoporosis, aneurysm, gastroesophageal reflex disease, chronic bilateral low back pain, polyuria and required additional surgical and non-surgical treatments.
Additional Manufacturer Narrative
The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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)." correction: f,h.1994 = "l" 3191,2328, 2564, 2519, 2330, 1930, 1862, 4572, 2119,1969 = "nl" 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.H3 other text : the device was not returned.
Additional Manufacturer Narrative
The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: 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).1994, 2475, 2422, 1750 = "l" 3191, 2328, 2564, 2519, 2330, 1930, 1862, 4572, 2119, 1969, 2240,1970, 2601, 2123, 1849, 1888, 2330, 2684, 1811,2252 = "nl" udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, suffering, disability, impairment.As per additional information received via medical records on 15nov2023 the patient had experienced increased abdominal pain post-surgical complications following vaginal prolapse repair, acute vaginitis, atrophy of the vagina, septic shock, vaginal bleeding, severe general pain, migraines, odorous dark-brown discharge, depression, back pain, frequent urge to urinate, abnormal discharge, bacterial infection, vision issues, sepsis, headache, terrible left eye glare, stroke, develops episodes of tremors and lightheadedness, shortness of breath syncope, dizziness, urinary tract infection, transient ischemic attack tia.Chronic thoracic compression deformities, dyslipidemia, osteoporosis, tricuspid valve regurgitation, palpitations, chest pressure, wheezes, anemia, vertigo, ataxia, age related osteoporosis, aneurysm, gastroesophageal reflex disease, chronic bilateral low back pain, polyuria and required additional surgical and non-surgical treatments.As per additional information received via medical records on 18-nov2024, the patient had experienced pelvic pain, cystocele, enterocele, hernias, pelvic tumors or fibroids, peritonitis, chronic vaginal infections, urinary tract infections, severe vaginal prolapse, rectocele, nausea, vomiting, sweats, probable rigor, abdominal pain, abdominal distension, abnormal vaginal discharge, fatigue, gastro esophageal reflux disease, age related osteoporosis, bilateral carotid artery occlusion, stress fracture of lumbar vertebra, sequela, acute vaginitis, atrophy of vagina, septic shock, vaginal bleeding, migraines, depression, back pain, urinary frequency, vision issues, internal tenderness, soreness, abnormal vaginal bleeding, dizziness, mesh erosion, chest discomfort, aneurysm, transient ischemic attack, tremors, dyslipidemia, dysuria, headache, thoracic aortic aneurysm, tricuspid valve regurgitation, palpitations, diarrhea, urinary urgency, sepsis and required additional surgical and non-surgical treatments.

• 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 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 17624121
• Report Number: 1018233-2023-06345
• Device Sequence Number: 17671872
• Product Code: OTO
• UDI-Device Identifier: 00801741016158
• UDI-Public: (01)00801741016158(11)150520(17)170428(10)HUZD0956
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2024

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: 04/28/2017
• Device Catalogue Number: Y100
• Device Lot Number: HUZD0956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 5 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 11/18/2024
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 12/07/2023; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Race: White