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

Catalog Number 486101

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Arthritis (1723); Erosion (1750); Cyst(s) (1800); Foreign Body Sensation in Eye (1869); Bone Fracture(s) (1870); Granuloma (1876); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Pain (1994); Rash (2033); Scarring (2061); Abnormal Vaginal Discharge (2123); Discharge (2225); Hernia (2240); Discomfort (2330); Sweating (2444); Prolapse (2475); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The sample was not returned.The lot number is unknown; therefore, the device 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 reactions: complications associated with the proper implantation of the avaulta plus¿ biosynthetic support system 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, rejection of biologic materials, 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).The information provided by bard 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 bard.(b)(4).The total number of events for product classification code otp is (b)(4).Qty (b)(4) - avaulta plus biosynthetic support system- anterior, sterile qty (b)(4) - avaulta plus biosynthetic support system- posterior, sterile qty (b)(4) - avaulta solo biosynthetic support system- anterior, sterile qty (b)(4) - avaulta solo biosynthetic support system- posterior, sterile (b)(4).Sample not received.

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced vaginal bleeding, chronic infection (infection), mesh protrusion, vaginal discharge, fishy smell, drainage, spotting, gastroesophageal reflux disease, auto immune disorder, rheumatoid arthritis, borderline hypertension, urinary stress incontinence, urinary urge incontinence, bunion deformity, dyspareunia, "feeling things are too tight," lower leg fracture, left foot pain, limping, hoarseness/vocal cord inflammation, hiatal hernia, cystic polyps (cysts), thyroid nodules, diverticula, sigmoid polyp, fibrocystic breast, varicose veins, mesh exposure, granulation tissue (granuloma), atrophic vaginitis (inflammation), recurrent urinary tract infection (uti), yeast/antimicrobial resistant fungi infection (fungal infection), rectocele (prolapse), vaginal lesions, irritation, foreign body sensation, discomfort, stricture, thinned tissue, vaginal angularity, cystitis, fluid retention, rash, escherichia coli in urine (bacterial infection), foreign body material (foreign body in patient), hot flashes, night sweats, lack of elasticity of vaginal tissue, erosion, perineal scarring (scarring), removal of perineal scarring (scar excision), and required additional surgical and non-surgical interventions.

Manufacturer Narrative

Original reporting time frame july 1, 2015 through august 31, 2015.(b)(4).

Manufacturer Narrative

(b)(4).Original reporting time frame (b)(6) 2015.

Manufacturer Narrative

(b)(4).Original reporting time frame (b)(6) 2015.The information provided by bard 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 bard.

Manufacturer Narrative

(b)(4).Original reporting time frame july 1, 2015 through august 31, 2015.The information provided by bard 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 bard.

Manufacturer Narrative

Exemption no.E2013025.Original reporting time frame july 1, 2015 through august 31, 2015.The information provided by bard 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 bard.

Manufacturer Narrative

Exemption no.E2013025.Original reporting time frame july 1, 2015 through august 31, 2015.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 PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Type of Device: AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• 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: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5114774
• MDR Text Key: 27176625
• Report Number: 1018233-2015-00365
• 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: Attorney
• Type of Report: Followup,Followup,Followup,Followup,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 486101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/29/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR