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

Catalog Number 486100

Device Problems Defective Device (2588); 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.Sample not returned.

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 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: ¿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)." 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 - 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
• MDR Report Key: 11096513
• MDR Text Key: 224425008
• Report Number: 1018233-2020-06419
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741168024
• UDI-Public: (01)00801741168024
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2009
• Device Catalogue Number: 486100
• Device Lot Number: HUSA1497
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 01/05/2021
• 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 - POSTERIOR; ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK; AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 69