MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN AVAULTA - BARD

Device Problem Material Erosion (1214)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2010

Event Type  malfunction  

Event Description

It was reported that the patient had avaulta mesh inserted into the front wall 10 years ago and now there was an erosion to the bladder and vagina with stone formation.It was stated that the avaulta mesh was deployed on (b)(6) 2010.On (b)(6) 2020, bladder stone was removed.On (b)(6) 2022, mesh was found to be eroded.On (b)(6) 2022, mesh removal and vesicovaginal fistula closure were performed.Mesh removal caused erosion to the bladder as well as bladder stones.On (b)(6) 2022, continued vesicovaginal fistula closure was performed.The consequence to the patient was mentioned as medical or surgical treatment.As per follow-up information, received via ibc on (b)(6) 2022, it was stated that a surgical procedure was done 12 years ago and it was a plastic reconstruction in the vagina.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient had avaulta mesh inserted into the front wall 10 years ago and now there was an erosion to the bladder and vagina with stone formation.It was stated that the avaulta mesh was deployed on (b)(6) 2010.On (b)(6) 2020, bladder stone was removed.On (b)(6) 2022, mesh was found to be eroded.On (b)(6) 2022, mesh removal and vesicovaginal fistula closure were performed.Mesh removal caused erosion to the bladder as well as bladder stones.On (b)(6) 2022, continued vesicovaginal fistula closure was performed.The consequence to the patient was mentioned as medical or surgical treatment.As per follow up information received via ibc on 20oct2022, it was stated that a surgical procedure was done 12 years ago and it was a plastic reconstruction in the vagina.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "excessive tension", "fiber size too large", or "mesh cords when stretched".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "adverse reactions: complications associated with the proper implantation of the avaulta plus¿ biosynthetic support system may include, but are not limited to those typically associated with surgically implantable materials, including: - postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.- urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.- perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, or any viscera, which may occur during the implantation procedure.- irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.- extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.- inflammation, sensitization, rejection of biologic materials, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.- urinary incontinence (stress and urge).Baw0302773 revision 0 was reviewed and was found to be adequate according to s03fa211 revision 17.The user guide currently states: adverse reactions complications associated with the proper implantation of the avaulta solo® synthetic support may include, but are not limited to those typically associated with surgically implantable materials, including: - postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.- urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.- perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, or any viscera, which may occur during the implantation procedure.- irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.- extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.- inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.- urinary incontinence (stress and urge)." h11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

• Brand Name: UNKNOWN AVAULTA - BARD
• Type of Device: UNKNOWN AVAULTA
• 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: 15713994
• MDR Text Key: 306892226
• Report Number: 1018233-2022-08292
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K083839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female