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

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Erosion (1750); Diarrhea (1811); Flatus (1865); Foreign Body Reaction (1868); Gastritis (1874); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Chills (2191); Dysphasia (2195); Hernia (2240); Stenosis (2263); Urinary Frequency (2275); Discomfort (2330); Depression (2361); Prolapse (2475); Sleep Dysfunction (2517); Dysuria (2684); Foreign Body In Patient (2687); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)

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: ¿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, 1869 = "l" 2348, 2361, 2597, 2993 = "nl".

Event Description

The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received, the patient has experienced depression, blood loss, pain in legs, right groin swelling, vaginal discharge, sensation of mesh coming out, vaginal pressure, tenderness, pain with sexual intercourse, palpable mesh, discomfort, urine leakage, sensation of a ¿bubble¿ in vagina, vaginal pain, bacilluria (bacterial infection), cystocele, dryness, urinary tract infection (uti), dysuria, mixed/urge/stress incontinence, palpable band of fibrous tissue (fibrosis), scar tissue, urinary frequency, burning sensation during intercourse, nocturia, back pain, night sweats, eroded mesh, mesh embedded in bladder (foreign body in patient), chronic inflammation, foreign material, foreign body giant cell reaction (foreign body reaction), vaginitis/vulvovaginitis, femoral hernia (hernia), and required additional surgical and non-surgical interventions.Per additional information received, the patient has experienced erosion of transvaginal mesh, pain, infection, unspecified urinary problems, recurrence, dyspareunia (pain) and required additional surgical interventions.Per additional information received via medical records on (b)(6) 2018, the patient has experienced pain, tenderness, dyspareunia, erosion, discharge, infection, dropped bladder, foreign body in patient, mixed incontinence, foreign body sensation, pelvic pain, inflammation, nerve damage, pain with sitting, nocturia, sleep disturbance, pressure while urinating, irritable bowel syndrome, chronic diarrhea, pelvic trauma, throbbing/stabbing vaginal pain, vaginal discharge, urinary retention, uterine prolapse, unspecified urinary problems, recurrence, cramping, muscle spasms, depression, elevated blood pressure, blood loss, chills, vaginal pain, burning sensation, night sweats, dysuria, leukocytes in urine, bladder neck hypermobility, foreign body reaction, vaginitis/vulvovaginitis, hernia, swelling, cystocele (prolapse), vaginal dryness, induration, pressure, discomfort, leakage, scar tissue, urinary tract infection, bacilluria, groin pain, nonsurgical and additional surgical interventions.Per additional information received via medical records on (b)(6) 2021, the patient has experienced mesh erosion, vaginal pain, burning on intercourse, dysuria, and yellowish discharge, painful urination, urinary frequency, dryness, extensive fibrosis, inflammation, focal fibrinoid necrosis, tenderness, dyspareunia, infection, reemerging incontinence, chronic pelvic pain, thoracic pain, vaginal stenosis, mixed urge and stress incontinence, vaginal discharge, knee pain, hip pain, right and left characterized as sharp pain, shooting pain, aching aggravated by walking, standing, joint pain.Back pain, achy in nature, constant, sharp, throbbing, located in the cervical, thoracic, and lumbar region on the right, left and midline, aggravated by activity, bending, lifting.Leg pain achy in nature, constant, sharp, shooting, located in the left and right upper and lower leg, aggravated by activity, mild vaginal atrophy, unspecified vaginitis and vulvovaginitis, epigastric pain, esophageal reflux, atrophic gastritis, diaphragmatic hernia, diarrhea, coronary artery disease, dysphagia, flatulence, mild antral gastritis, mild bile reflux, facet joint syndrome 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: 11806363
• MDR Text Key: 249998763
• Report Number: 1018233-2021-80039
• 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
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Catalogue Number: 486100
• Device Lot Number: HUTF2232
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 19 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2009
• 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: CAPIO¿ SLIMSUTURE CAPTURING DEVICE; PELVILACE® TO BIOURETHRAL SUPPORT SYSTEM HOOK
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 86