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

Model Number	BRD300RS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Incontinence (1928); Nerve Damage (1979); Pain (1994); Urinary Tract Infection (2120); Depression (2361); Prolapse (2475); Dysuria (2684); Foreign Body In Patient (2687); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed.No sample was returned for evaluation and the lot number is unknown.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 device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state 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.1979, 2120, 2475, 1928, 1750,1994 = "l".2348, 1966, 2361, 2687, 2684 = "nl".
Event or Problem Description
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced organ, tissue, and nerve damage, urinary incontinence, mesh erosion, pain, injury, and has required additional surgery.Per additional information received via medical records on (b)(6) 2022, the patient has experienced urinary tract infection, pelvic pain, pelvic floor weakness, spasm of muscle, depression, rectovaginal incompetence, rectocele, vaginal foreign body, pelvic organ prolapses, urge and stress incontinence, urgency, nocturia, cystocele, dysuria, vaginal mesh erosion, and required additional surgical and non-surgical interventions.
Additional Manufacturer Narrative
The reported event could not be confirmed.No sample was returned for evaluation and the lot number is unknown.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 device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state 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 led 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." correction: a, b, d, e, f, h.1979, 2120, 2475, 1928, 1750,1994 = "l".2348, 1966, 2361, 2687, 2684 , 3191 = "nl".Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced organ, tissue, and nerve damage, urinary incontinence, mesh erosion, pain, injury, and has required additional surgery.Per additional information received via medical records on 28nov2022, the patient has experienced urinary tract infection, pelvic pain, pelvic floor weakness, spasm of muscle, depression, rectovaginal incompetence, rectocele, vaginal foreign body, pelvic organ prolapses, urge and stress incontinence, urgency, nocturia, cystocele, dysuria, vaginal mesh erosion, and required additional surgical and non-surgical interventions.Per additional information received via medical records on 09dec2024, the patient had experienced pelvic organ prolapse, vaginal vault prolapse), stress urinary incontinence, intraabdominal adhesions, erosion of exposed sub-urethral sling, symptomatic rectocele, vaginal cuts and required additional surgical and non-surgical treatments.

• Brand Name: ALIGN® RS RETROPUBIC/SUPRAPUBIC URETHRAL SUPPORT SYSTEM
• Common Device Name: ALIGN® RS URETHRAL SUPPORT SYSTEM
• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 15983991
• Report Number: 1018233-2022-09508
• Device Sequence Number: 5724601
• Product Code: OTN
• UDI-Device Identifier: 00801741016196
• UDI-Public: (01)00801741016196(11)120622(17)140630(10)HUWF0540
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: BRD300RS
• Device Catalogue Number: BRD300RS
• Device Lot Number: HUWF0540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALYTE Y-MESH GRAFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White