MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AJUST® ADJUSTABLE SINGLE-INCISION SLING

Catalog Number BRD700SI

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Vomiting (2144); Urinary Frequency (2275); Intermenstrual Bleeding (2665); 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: precautions: the usual precautions associated with urological procedures should be followed: based on physician experience and training, a thorough assessment of each patient should be made to determine their suitability for the implant procedure.Additional consideration should be given to use of the implant in patients with a compromised immune system, any condition that would compromise healing, or any patient with a history of prior abdominal or pelvic surgeries.Consideration should also be given to the ability of the patient to tolerate the surgical procedure.Accepted surgical practice and precautions must be followed for the management of contaminated or infected wound sites, when the ajust¿sling system is used.Postoperative bleeding may occur in some patients and must be controlled prior to patient release.The implant procedure requires diligent attention to anatomical structures and care to avoid puncture of large vessels, nerves, bladder, bowel, urethra and any viscera, during introducer passage.Due to anatomical distortion that can be caused by pelvic organ prolapse, if the patient requires cystocele repair, it should be performed prior to the implantation of the sub-urethral sling.Proper placement of the sling implant at the mid-urethra requires that it lie flat with minimal or no tension under the urethra.The ajust¿ sling system is intended as a single-use device.Do not resterilize any portion of the ajust¿ sling system.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Patients should be advised that pregnancy following a sling implant procedure may negatively affect the success of the previous implant procedure and incontinence may recur.The safety and effectiveness of the ajust¿ sling system implant procedure has not been established for the treatment of stress urinary incontinence in males or children under the age of 18.Cystoscopy can be considered at the physician¿s discretion.Check the integrity of the packaging before use.Do not use the implant or introducers if the packaging is opened or damaged.As for any implantable material, it is recommended to open the package at the time of implantation.Upon opening the ajust¿ sling system tray, the components should be carefully transferred into the sterile field.The tray should not be inverted to remove components.Post-operatively the patient should be advised to refrain from heavy lifting, exercise (e.G.Cycling, jogging) and/or intercourse until the physician determines it is suitable for the patient to return to normal activities.Adverse events: complications associated with the proper implantation of the ajust¿ sling system may include, but are not limited to: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding 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, 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 incontinence.1994, 1750="l".2348, 2993, 2665="nl".

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 postoperative vaginal bleeding, mixed incontinence, other urinary incontinence, pelvic pain, incomplete bladder emptying, erosion of vaginal mesh, frequency, less frequent bowel movements, some pressure, recurrent stress urinary incontinence, overactive bladder syndrome, urgency, urgency urinary incontinence, mesh exposure/extrusion, spasms and cramping at the end of the day, urinary leakage, and urinary stream not being straight.She required surgical and non-surgical interventions such as complex revision/excision of mid urethral sling and cystourethroscopy ((b)(6) 2016), a cystoscopy ((b)(6) 2016), need to empty bladder every two hours, and vesicare.Per additional information received on 12jul2021, the patient has experienced mesh erosion, tissue erosion, exposed and protruding mesh, pain, bleeding, infection and dyspareunia, and required a second surgery to remove the product.Patient underwent a revision surgery to remove the ajust on (b)(6) 2016.

Event Description

Per additional information received via medical records on (b)(6)2022, the patient has experienced erosion of vaginal mesh, incomplete bladder emptying, pelvic pain, mixed incontinence, diffuse connective tissue disease, nausea vomiting, overactive bladder syndrome: frequency, urgency, occasional urge urinary incontinence (uui), raynaud¿s syndrome, chilblain and required additional surgical and non-surgical interventions.

Manufacturer Narrative

1930="l" 1928, 2034, 2144, 2519, 2564, 2193, 1966, 1871, 2275="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.

• Brand Name: AJUST® ADJUSTABLE SINGLE-INCISION SLING
• Type of Device: AJUST® ADJUSTABLE SINGLE-INCISION SLING
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 12205526
• MDR Text Key: 262744612
• Report Number: 1018233-2021-80052
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 00801741168000
• UDI-Public: (01)00801741168000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092607
• 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: 12/05/2022

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: 05/31/2011
• Device Catalogue Number: BRD700SI
• Device Lot Number: CVTD0028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 17 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2009
• 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): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 59 KG