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

Catalog Number 486201

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

Patient Problems Stacking Breaths (1593); Abdominal Pain (1685); Asthma (1726); Erosion (1750); Cellulitis (1768); Chest Pain (1776); Hair Loss (1877); Hematoma (1884); Incontinence (1928); Muscle Weakness (1967); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Dizziness (2194); Hernia (2240); Sneezing (2251); Arthralgia (2355); Neck Pain (2433); Weight Changes (2607); Intermenstrual Bleeding (2665); Renal Impairment (4499); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521)

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.1884, 1750, 1930="l".1593, 1776, 2194, 2433="nl".

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.Product was used for therapeutic treatment.Per additional information received, the patient has experienced foley catheter after surgery, opening of incision with small amount of blood, bruising of buttocks bilaterally with right side induration, hematoma, stress urinary incontinence, continuous discharge treated with metrogel, menses closer together, spotting, dyspareunia, anteverted cervix, hemorrhoids with blood in stool, pain in right bottom cheek, vaginal discharge, spasms in rectum making her double over, multiple in-office graft trimmings due to continued graft protrusion and rejection of graft with abnormal uterine bleeding, subsequent explant due to rejection of avaulta graft and three hernia repair surgeries post explant.Per additional information received on 11oct2021, the patient has experienced chest pain, shortness of breath, dizziness, neck pain with radiation to the shoulder and left arm with paresthesia, numbness in the upper extremity, tenderness in left anterior chest, mesh erosion, pelvic pain, bleeding from vagina and rectum, pain during sexual intercourse, asthma, hypothyroidism, kidney disease chronic stage-iii, skin cancer, mesh exposure, urinary leakage, cough, sneezing, hardness in the right butt cheek, cellulitis, hematoma from right buttock, infection, elevated tsh hormone, arthralgias and inguinal lymphadenopathy, reactive leukocytosis, hip pain, joint pain , wrist pain, inability to walk, leg weakness, back pain, rectal bleeding, spasms, dyspareunia, urinary retention, vaginal discharge, hole in vaginal mucosa, hair loss, weight loss, cramps, enterocele, hernia, recurrent vaginal pain and required additional surgical and non-surgical interventions.

• Brand Name: AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Type of Device: AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
• 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: 12688495
• MDR Text Key: 278101187
• Report Number: 1018233-2021-80076
• 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: 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: 486201
• Device Lot Number: CVRI0042
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2007
• 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
• Treatment: MONARCH ¿ SUBFASCIAL HAMMOCK
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 61