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

Catalog Number 486200

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

Patient Problems Cyst(s) (1800); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Blurred Vision (2137); Dizziness (2194); Hernia (2240); Urinary Frequency (2275); Discomfort (2330); Depression (2361); Prolapse (2475); Hematuria (2558); Abdominal Distention (2601); Osteopenia/ Osteoporosis (2651); Fibrosis (3167); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); 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: precautions: caution: federal (usa) law restricts this device to sale by or on the order of a physician.Avaulta solo¿ synthetic 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.Avaulta solo¿ synthetic 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 solo¿ synthetic 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 synthetic 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.2475, 1932, 2120="l".2193, 2330, 2993, 2361="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 on 11oct2021, the patient has experienced pain, discomfort, extreme dryness during sexual intercourse, urinary tract infections, depression, dyspareunia, mesh broken inside the patient, enterocele, severe cramps, cystocele, hernia, fibroids, rectocele, bladder infections, vaginal vault prolapse, uterine prolapse, urinary incontinence, urinary retention, recurrent vaginal pain, mesh exposure in vagina, urinary frequency, urinary leakage, urge incontinence, nocturia, urinary urgency, lower back pain, endocervical polyps, minimal urethral hypermobility, ovarian cyst, mild pelvic tenderness, hematuria, abdominal distention, osteoporosis, gastroesophageal reflux disease, low bone density, enlarged liver, nodule in the superior aspect of the right breast, chronic inflammation, foreign body giant cell reaction and fibrosis and benign squamous mucosa, dizziness, blurred vision and required additional surgical and non-surgical interventions.

Manufacturer Narrative

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.

• Brand Name: AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Type of Device: AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12688557
• MDR Text Key: 278108501
• Report Number: 1018233-2021-80079
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K082571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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: 05/31/2011
• Device Catalogue Number: 486200
• Device Lot Number: HUTD1818
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO.; AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR.; ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO; AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 76