MAUDE Adverse Event Report: BARD SHANNON LIMITED ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC

Catalog Number BRD200S

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Cyst(s) (1800); Hemorrhage/Bleeding (1888); Incontinence (1928); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Obstruction/Occlusion (2422); Prolapse (2475); Constipation (3274); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 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, 1987, 2061, 1800, 2475, 1928, 2422, 2120, 2119, 1932, 1941, 2060, 2275 = "l." 2348, 1685, 3274, 2564, 2519, 1695, 2193, 2597, 1970, 2517, 2145 = "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.H3 other text: device not returned.

Event Description

The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received, the patient has experienced pain, unspecified urinary problems, unspecified bowel problems, organ perforation, unspecified neuromuscular problems, vaginal scarring, ovarian cyst, rectocele (prolapse), weak rectocervical fascia, adnexal tenderness, right sided abdominal pain, dyspareunia, decreased sphincter tone, incomplete defecation/bladder emptying, urge urinary incontinence, spontaneous loss of urine, need to change position or reduce prolapse to urinate/defecate, heaviness/lower pelvic pressure, lower back pain, constipation, and required additional surgical and non surgical interventions.Per additional information received via medical records on 12/12/2017, the patient has experienced painful sex, constant bladder leakage/bladder leaks, difficulty urinating, vaginal vault prolapse, rectocele, incontinence, adhesions, bowel obstructions, chronic constipation, collagen disorder, irritable bowel syndrome, dyspareunia, rectocele (prolapse), recurrent urinary tract infections, recurrent vaginal pain/cramping/pressure, urinary incontinence, urinary retention, vaginal vault prolapse, pain and required nonsurgical interventions.Per additional information received via medical records on 01/04/2018, the patient has experienced blood loss, pain, nausea, bulging, vaginal prolapse, rectocele, cystocele, right side abdominal pain, dyspareunia, pelvic pressure, lower back pain, nocturia (sleep disturbances), constipation, incomplete bladder emptying (urinary retention), urge incontinence, spontaneous urine loss (urinary incontinence), weakness of recto-cervical fascia (weakness), mild tenderness, decreased sphincter tone, acute/chronic inflammation of cervix (inflammation), right ovarian follicular cyst, adhesions, right paratubal cysts, fecal incontinence, left ovarian cyst and required additional surgical and non-surgical interventions.Per additional information received via medical records on 6/20/2018, the patient has experienced prolapse, incontinence, need to change position or reduce prolapse to urinate/defecate, heaviness and lower pelvic pressure, lower back pain, limited sexual activity secondary to prolapse, nocturia, constipation, inability to empty bladder/rectum completely with need to manually reduce posterior vagina for bowel movements, bulge, right-sided abdominal pain, dyspareunia, stage i-ii rectocele, weak recto cervical fascia, decreased sphincter tone, incomplete defecation, urge incontinence, fecal incontinence, rectal irritation without bowel movements, pelvic pain and cystocele.She required surgical interventions such as diagnostic laparoscopy, posterior elevate implantation, and sphincteroplasty (on (b)(6) 2011) and unspecified surgery (noted on (b)(6) 2012).Per the ppf, the patient also alleged organ perforation unspecified neuromuscular problems, and vaginal scarring.Per additional information received via medical records on october 3, 2018, the patient has experienced urine culture positive for enterococcus species, recurrent urinary tract infections, incontinence, need to change position or reduce prolapse to urinate/defecate, heaviness and lower pelvic pressure, lower back pain, limited sexual activity secondary to prolapse, nocturia, constipation, inability to empty bladder/rectum completely with need to manually reduce posterior vagina for bowel movements, bulge, right-sided abdominal pain, dyspareunia, stage i-ii rectocele, weak recto cervical fascia, decreased sphincter tone, incomplete defecation, urge incontinence, fecal incontinence, vaginal vault prolapse, rectal irritation without bowel movements, pelvic pain, cystocele, flank pain, hesitancy, and frequency.She required surgical interventions such as diagnostic laparoscopy, posterior elevate implantation, and sphincteroplasty (on (b)(6) 2011).Per the ppf, the patient also alleged organ perforation unspecified neuromuscular problems, and vaginal scarring.

• Brand Name: ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC
• Type of Device: ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC
• Manufacturer (Section D): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791 ; * 00791
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791 ; * 00791
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 18382660
• MDR Text Key: 331184971
• Report Number: 1018233-2023-090008
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016189
• UDI-Public: (01)00801741016189
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: KO93747
• 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
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: BRD200S
• Device Lot Number: HUUF1338
• Was Device Available for Evaluation?: No
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2010
• 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
• Treatment: COSEAL SURGICAL SEALANT.
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 82 KG