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

Catalog Number 486201

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

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Perforation (2001); Discomfort (2330); Prolapse (2475); Constipation (3274); Dyspareunia (4505); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/11/2024

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 dhr review did not indicate any manufacturing nonconformance that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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 and biologic materials.- 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.- post-operatively the patient is recommended to refrain from heavy lifting and/or exercise (i.E.Cycling, jogging) for at least three to four weeks and intercourse for one month.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." 1750,2475,1987,2001="l" 1994,1928,3274,2330,1888="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.

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.As per additional information received via medical records on (b)(6) 2024, the patient had experienced rectal erosion, prolapse, stress incontinence, bowel perforation, chronic constipation, pelvic discomfort, cystocele, dyspareunia, obesity, pelvic tumors or fibroids, rectocele, urinary incontinence, pelvic pain, rectal pain vaginal pain, vaginal bleeding and rectal bleeding and required additional surgical non-surgical treatment.

• 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 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18655421
• MDR Text Key: 334721677
• Report Number: 1018233-2024-00530
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2024

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: 10/31/2010
• Device Catalogue Number: 486201
• Device Lot Number: CVSKX008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2008
• 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): Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White