MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR

Catalog Number 486100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Apnea (1720); Asthma (1726); Erosion (1750); Fatigue (1849); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Unspecified Infection (1930); Nausea (1970); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Hernia (2240); Distress (2329); Prolapse (2475); Hematuria (2558); Cancer (3262); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation and the lot number is unknown.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 alleged event is most likely associated with possible procedural/surgical complications.The lot number is unknown; therefore, the device history record could not be reviewed.The ifu currently addresses potential risks associated with surgically implantable materials which states the following: precautions: based on physician experience and training, a thorough assessment of each patient should be made to determine their suitability for the implant procedure.Additional consideration should be given to use of the implant 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.Avaulta solo® synthetic support system implantation procedures require diligent attention to anatomical structures and care to avoid puncture of large vessels, nerves, bladder, bowel, urethra, rectum, or any viscera during introducer passage.The avaulta solo® synthetic support system is provided in a sterile blister tray within a sterile pouch.The sterile blister tray may be placed in the sterile field.The introducers provided with the anterior and posterior synthetic support systems are provided in a sterile blister tray.Transfer the introducer to the sterile field using aseptic techniques.Do not place the tray in the sterile field.Check the integrity of the packaging before use.Do not use the mesh or introducers if the packaging is opened or damaged.As for any implantable material, it is recommended to open the blister tray at the time of implantation.The avaulta solo® synthetic support system is intended as a single-use device.Do not re-sterilize any portion of the avaulta solo® synthetic support system.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 reactions: complications associated with the proper implantation of the avaulta solo® synthetic support 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 Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Per additional information received via claim record on 14feb2022, the patient has experienced a recurrent urinary tract infection, hematuria, bleeding, erosion of the vaginal mesh, mental and physical pain, disability, suffering, permanent injuries, substantial physical deformity, severe emotional distress and required additional surgical and non-surgical interventions.

Manufacturer Narrative

1928, 1930, 2119, ="l".2475, 2193, 1760, 2240, 1914="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.

Event Description

Per additional information received via medical records on 26apr2022, the patient has experienced prolapsed bladder, a tear in her vaginal wall, pelvic pain, vaginal pain, severe low back pain, rectocele, abnormal bladder control, significant exposure/erosion, hematuria, recurrent stress urinary incontinence, infection, pelvic pressure, cramping, clotting, cancer, connective tissue disorder, hernias, hypotension or low blood pressure, immune system disease or dysfunction including hiv/aids, pelvic trauma, pelvic tumors or fibroids, urinary retention, wound healing problems and required additional surgical and non-surgical interventions.

Manufacturer Narrative

1720, 1849, 1970, 1726, 1908=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.

Event Description

Per additional information received via medical records on 23may2022, the patient has experienced kidney function, hematuria, rectocele, recurrent stress urinary incontinence, recurrent urinary tract infection, vaginal bleeding, mesh exposure with granulation tissue and bleeding, prolapsed bladder, a tear in her vaginal wall, pelvic pain, vaginal pain, severe low back pain, abnormal bladder control, pelvic pressure, cramping, clotting, cancer, connective tissue disorder, hernias, hypotension or low blood pressure, immune system disease or dysfunction including hiv/aids, pelvic trauma, pelvic tumors or fibroids, urinary retention, wound healing problems, right knee pain, chronic lymphocytic leukemia, gastroesophageal reflux disease, hypertension, asthma, cervicalgia, sleep apnea, restless leg syndrome, fatigue, nausea with vomiting, raised antinuclear antibody, urgency of urination, migraine, high sodium level and required additional surgical and non-surgical interventions.

• Brand Name: AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Type of Device: AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 13636317
• MDR Text Key: 287602110
• Report Number: 1018233-2022-90005
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 486100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALIGN TRANSOBTURATOR URETHRAL SUPPORT SYSTEM.; ALIGN TRANSOBTURATOR URETHRAL SUPPORT SYSTEM.; ALIGN TRANSOBTURATOR URETHRAL SUPPORT SYSTEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 77 KG