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 Abscess (1690); Erosion (1750); Cellulitis (1768); Cyst(s) (1800); Emotional Changes (1831); Fever (1858); Fistula (1862); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Muscle Weakness (1967); Myocardial Infarction (1969); Pain (1994); Sepsis (2067); Urinary Retention (2119); Urinary Frequency (2275); Anxiety (2328); Prolapse (2475); Hematuria (2558); Dysuria (2684); Cancer (3262); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/16/2023

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 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." 1994="l." 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 Description

It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, suffering, disability, impairment.

Event Description

It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, suffering, disability, impairment.Per additional information received via medical records on (b)(6)2023, the patient has experienced extreme pain, knots and swelling in pelvic area, fever/chills, anxiety, emotional damage, prolapse, urinary frequency, vulvar abscess, wound vac placed, mesh infection, cellulitis, sepsis, chronic anemia, leukocytosis, cystocele, cancer, fistulas, pelvic tumors or fibroids, rectocele, recurrent vaginal pain, urinary incontinence, urinary retention, uterine prolapse, vaginal vault prolapse, hypertension, microscopic hematuria, nephrolithiasis, non st elevated myocardial infarction, bladder tumor, erosion of vaginal mesh, vaginal prolapse, dysuria, papillary thyroid carcinoma, hypothyroidism, bilateral ovarian cyst, endometriosis, overactive bladder, levator spasm, adnexal mass, intra-abdominal infection, viral disease, bladder pain, bladder spasms, muscle weakness, cutaneous abscesses, pelvic abscesses, hypokalemia, deep post-operative wound infection, intra-abdominal infection, lipid screening, kidney stones, myocardial infarction 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 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." 1994 = "l" 4577,1858,2328,2475,2275,1930,1768,2067,3262, 1862,4572,2119,1800,4521,1967,1690,4825,1969 = "nl" correction: f,h.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.H3 other text : the device was not returned.

• 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 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: 17049971
• MDR Text Key: 316401881
• Report Number: 1018233-2023-03997
• Device Sequence Number: 1
• Product Code: OTN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: BRD100R
• Device Catalogue Number: BRD100R
• Device Lot Number: HUUD0254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2010
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 66 KG