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

Catalog Number 486101

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Arthritis (1723); Erosion (1750); Calcium Deposits/Calcification (1758); Chest Pain (1776); Diarrhea (1811); Fatigue (1849); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Pain (1994); Sepsis (2067); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Urinary Frequency (2275); Discomfort (2330); Depression (2361); Prolapse (2475); Abdominal Cramps (2543); Osteopenia/ Osteoporosis (2651); Intermenstrual Bleeding (2665); Dysuria (2684); Total Hearing Loss (4473); Renal Impairment (4499); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The alleged event is most likely associated with possible procedural/surgical complications.The ifu currently addresses potential risks associated with surgically implantable materials which states the following: adverse reactions.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.Precautions caution: federal (usa) law restricts this device to sale by or on the order of a physician.The avaulta plus¿ biosynthetic support system should only be used by physicians who are trained in the surgical procedures and techniques required for pelvic floor reconstruction and the implantation of nonabsorbable meshes.Acceptable surgical practices should be followed for the management of infected or contaminated wounds.The avaulta plus¿ biosynthetic support system implantation procedures require diligent attention to anatomical structure and care to avoid puncture of large vessels, nerves, bladder, bowel, rectum, or other viscera during needle passage.The avaulta plus¿ biosynthetic support system is provided in a sterile blister tray within a sterile pouch.The sterile blister tray may be placed in the sterile field.The introducers provided with the anterior and posterior support systems are provided in a sterile blister tray.Transfer the introducer to the sterile field using aseptic techniques.Do not place the tray in the sterile field.Check the integrity of the packaging before use.Do not use the mesh or introducers if the packaging is opened or damaged.As for any implantable material, it is recommended to open the blister tray at the time of implantation.After use, any unused product and packaging should be treated as a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.(b)(4).No sample received.

Event Description

It was reported that a patient had surgery to repair a prolapse using bard avaulta transvaginal mesh.The patient got very sick and was admitted to the hospital with fever and infection they had to surgically put in a drain.Her blood pressure dropped very low and her kidneys stopped working for 12 hours, due to sepsis.They removed the drain and released her from the hospital.She had to return to her doctor because of continued bleeding and pain.He found that the mesh had eroded through the vaginal wall.She had to have surgery to remove part of the mesh.Further problems from the mesh include but are not limited to continued pain, pain during very limited intercourse, worry about further problems from remaining mesh, feeling very inadequate and unattractive to her husband.Physically and emotionally exhausted from all the problems.The device was used for therapeutic tx.Per additional information received, the patient has experienced postoperative fevers and rigors, pelvic pain, pelvic abscess, urinary incontinence, bladder suspension, detrusor instability, grade 3 rectocele, grade 3 enterocele, recurrent urinary tract infections and dyspareunia.Per additional information received, the patient has experienced fever, sepsis, kidney stopped working for 12 hours, hospitalization on (b)(6) 2007 through (b)(6) 2007, erosion of mesh, bleeding, pain, and continuing pain during intercourse.Per additional information received on (b)(6) 2021, the patient has experienced bleeding and erosion through vaginal wall, fever, sepsis, renal impairment, chronic and severe pain, pain during sexual intercourse, bladder infections, prolapse, chest pain, cystocele, hypertension, depression, stress urinary incontinence, blurred vision, lower abdominal pain, urinary frequency, nocturia, urge incontinence, pain in right breast, loss of hearing unspecified, esophageal reflux, meniere¿ disease unspecified, urinary calculi, osteoarthrosis, fibromyalgia, migraine headache, unspecified hyperlipidemia, rectocele, fatigue, urinary tract infection site not specified, seasonal allergies, pelvic pain, arthritis, bladder suspension, pelvic abscess, osteoporosis, cough, nephrolithiasis, dysuria, diarrhea, abdominal cramps, vaginal discharge, coronary artery disease, hypercholesterolemia, palpitations, vulvar atrophy, overactive bladder syndrome, acute right lumbar radiculopathy, spinal stenosis of lumbosacral region, sacroiliac joint dysfunction of right side, degenerative disc disease, insomnia, tinnitus, sinusitis, discomfort, green discharge and required additional surgical and non-surgical interventions.

• Brand Name: AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM: ANTERIOR
• Type of Device: AVAULTA PLUS BIOSYNTHETIC 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); 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 12688494
• MDR Text Key: 279013826
• Report Number: 1018233-2021-80077
• 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: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2008
• Device Catalogue Number: 486101
• Device Lot Number: CVRI0040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2007
• 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: 58 YR
• Patient Weight: 75