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

Catalog Number 486200

Device Problems Material Erosion (1214); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Injury (2348); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.No sample received.

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced constipation, mesh exposure, mesh erosion, recurrent bladder infections, 3 cm x 4 mm extrusion of mesh, extended spectrum beta-lactamases, burning, urgency, dysuria, cloudy urine, urinary frequency, cystocele, granulomatous reaction, vaginal mucosa, exhibiting mild fibrosis, inflammation of the submucosa, mesh pain, recurrent or worsening urinary incontinence, pain with intercourse, vaginal (apical) prolapse, pressure, vaginal fullness, needing to push near the anus or inside the vagina to evacuate bowel movements, slow urinary stream, trouble urinating, frequency and or urgency of urination, needing to push the bladder in to urinate, and irritation from prolapse beyond the opening of the vagina.The patient required additional surgical and non-surgical interventions.

Manufacturer Narrative

The sample was not returned.The lot number is unknown; therefore, the device lot history record could not be reviewed.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: ¿potential adverse reactions are those typically associated with surgically implantable materials, including hematoma, seroma, mucosal or visceral erosion, infection, inflammation, sensitization, dyspareunia, scarification and contraction, fistula formation, extrusion and recurrence of vaginal wall prolapse.Perforations or lacerations of vessels, nerves, bladder, bowel, rectum, or any viscera may occur during needle passage." 1750="l".2348, 3274, 2993 = "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 - POSTERIOR
• Type of Device: AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11096439
• MDR Text Key: 224423385
• Report Number: 1018233-2020-06420
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741168031
• UDI-Public: (01)00801741168031
• Combination Product (y/n): N
• PMA/PMN Number: K082571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2008
• Device Catalogue Number: 486200
• Device Lot Number: HUSA0561
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK; AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR; ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK; AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 69