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 Abdominal Pain (1685); Erosion (1750); Micturition Urgency (1871); Pyrosis/Heartburn (1883); Hemorrhage/Bleeding (1888); Incontinence (1928); Inflammation (1932); Nausea (1970); Pain (1994); Urinary Retention (2119); Myalgia (2238); Discomfort (2330); Injury (2348); Disability (2371); Neck Pain (2433); Constipation (3274); Dyspareunia (4505); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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: ¿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).Per direction by fda in an email dated june 26, 2019, this emdr is being filed to submit new information obtained prior to a letter received on may 15, 2019, regarding the revocation of the asr for exemption e2013025.It was agreed upon with the fda that the date of awareness would be the date of the email received, which is june 26, 2019.

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.Reason for report: revocation of asr, report id number: (b)(4), corresponding exemption number: e2013025.

Event Description

Per additional information received via medical records on 11apr2022, the patient has experienced mesh related complications, bleeding/clotting disorders, vaginal pain, bladder leakage, vaginal bleeding, painful intercourse, intermittent vaginal spotting, vaginal discomfort, vaginal dryness, mesh exposure, pelvic pain, chronic constipation, urinary incontinence, urinary retention, dyspareunia, and required additional surgical and non-surgical interventions.

Manufacturer Narrative

2119 = "l".3274, 1928, 2330 = "nl".Correction: g1.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

As per additional information received via medical records on 11jan2024, the patient had experienced mesh erosion, pelvic pain, atrophic vaginitis, mesh exposure, vaginal pain, bladder leakage, vaginal bleeding, painful intercourse, intermittent vaginal spotting, vaginal discomfort, vaginal dryness, chronic constipation, dyspareunia, urinary incontinence, urinary retention, urinary urgency, heartburn, nausea, back pain, joint pain, myalgia, neck pain, lower quadrant pain and required additional surgical and non-surgical treatments.

Manufacturer Narrative

1750,1932,= "l." 3274,1888,1871,1883,1970,2355,2433,1685,2238= "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.

• 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: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8760613
• MDR Text Key: 150019914
• Report Number: 1018233-2019-03627
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741168024
• UDI-Public: (01)00801741168024
• 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: 02/02/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 486100
• Device Lot Number: HUUG2125
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 16 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 04/11/2022; 01/11/2024
• Supplement Dates FDA Received: 05/04/2022; 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2010
• 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® TO URETHRAL SUPPORT SYSTEM - HOOK.; ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK.; ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK.; ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White