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 Adhesion(s) (1695); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Discomfort (2330); Prolapse (2475); Constipation (3274); Unspecified Gastrointestinal Problem (4491); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Per additional information received via medical records on (b)(6) 2018, the patient has experienced blood loss.Per additional information received on (b)(6) 2022, the patient has experienced pain and disability.

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.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.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.2848, 2597, 1994, 2371 = "nl".

Manufacturer Narrative

1695, 3274, 1908, 1914, 2119, 2475, 2193, 2123, 2330 = "nl".H11: section a through f - 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.

Event Description

Per additional information received via medical records on 01dec2023, the patient had experienced adhesion, bleeding/clotting, chronic constipation, inflammatory bowel syndrome, cystocele, diverticulitis, dyspareunia, hypertension, hypotension, obesity, rectocele, recurrent or chronic vaginal or bladder infections, vaginal pain, urinary incontinence, urinary retention, vaginal vault prolapse, pelvic pain, obstipation, slight pinkish discharge and leaks, intestinal problem, pain, cramping, discomfort to lower abdomen and required additional surgical and non-surgical treatments.

• 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: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 15518967
• MDR Text Key: 300996259
• Report Number: 1018233-2022-90032
• 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,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2008
• Device Catalogue Number: 486201
• Device Lot Number: CVRFX091
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2007
• 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: TVT RETROPUBIC SYSTEM; TVT RETROPUBIC SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female