MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC

Model Number BRD100R

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

Patient Problems Erosion (1750); Fatigue (1849); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Depression (2361); Prolapse (2475); Hematuria (2558); Cancer (3262); Constipation (3274); Cramp(s) /Muscle Spasm(s) (4521)

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) 2022, the patient has experienced erosion of implanted urethral mesh to surrounding organ or tissue, pelvic pain, bladder pain, recurrent bladder stones, migration and embedded mesh, recurrence of stress urinary incontinence, discomfort, urinary tract infection, cancer, pelvic tumors or fibroids, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain and required additional surgical and non-surgical interventions.

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 align® urethral support 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.Cystoscopy should be performed to confirm bladder integrity or recognize a bladder perforation.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 mid-urethra requires that it lie flat with minimal or no tension under the urethra.The align® urethral support system is intended as a single-use device.Do not re-sterilize any portion of the align® urethral support 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 mesh sling implant procedure may negatively affect the success of the previous implant procedure and incontinence may recur.The safety and effectiveness of the align® urethral support system implant procedure has not been established for the treatment of stress urinary incontinence in males or children under the age of 18.Check the integrity of the packaging before use.Do not use the align® urethral support system if the packaging is opened or damaged.As for any implantable material, it is recommended to open the package at the time of implantation.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 align® urethral support 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 overcorrection/ 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.2120,1750, 1930= "l".2348, 1994, 2330, 1760, 2120, 1928, 2564, 2519="nl".

Event Description

Per additional information received via medical records on (b)(6)2022, the patient has experienced bladder stone which developed on a foreign body, mesh erosion, pelvic pain, bladder pain, migration of mesh, embedded mesh, recurrent urinary tract infection, recurrent bladder stones, recurrence and exacerbation of stress urinary incontinence, chronic pain, infections, blood and bacteria in urine, chronic discomfort, perforation of bladder wall, chronic debilitating cramping, constipation, fatigue, prolapse, depression, thyroid and required additional surgical and non-surgical interventions.

Manufacturer Narrative

2558, 2001, 2193, 3274, 1849, 2475, 2361, 2102="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: ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
• Type of Device: ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
• 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: 15128527
• MDR Text Key: 296847904
• Report Number: 1018233-2022-90023
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741016172
• UDI-Public: (01)00801741016172
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093747
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: BRD100R
• Device Catalogue Number: BRD100R
• Device Lot Number: HUYC0787
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 7 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2014
• Is the Device Single Use?: No
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 58 KG