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

Model Number	BRD600HH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Urinary Frequency / Polyuria (2275); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: ¿complications associated with the proper implantation of the align® to 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 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." (b)(4).
Event or Problem Description
The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced urgency and frequency, levator and anal spasms, urge incontinence, bladder spasms, midline cystocele, stress incontinence, rectocele, vaginal apical prolapse grade two, anterior colporrhaphy with sacrospinous ligament fixation using a human dermal graft, vaginal mesh excision, transvaginal suburethral sling (tvt sling) biologic using human fascia lata, diagnostic cystoscopy, and smoking, egd with biopsy (x2), ulcerative gastritis and hiatal hernia, recurrent urinary tract infections, abnormal location of suburethral sling, hypermobile urethra, pain, erosion, extrusion, infection, urinary problems, bowel problems, fistulae, recurrence, bleeding, neuromuscular problems, vaginal scarring, severe dyspareunia, suspected interstitial cystitis, multiple hemorrhagic cysts and ulcers throughout the bladder, urethral scar, paravaginal defects, severe abdominal pain, pelvic prolapse, severe chronic pelvic pain and pressure with pulling sensation, palpable mesh on anterior vaginal wall, bladder spasms, acute vaginitis, dysuria, fever, urine retention, proctocele, herniation of rectum into vagina, frequency, difficulty urinating, incomplete emptying, pelvic muscle spasms, pelvic disproportion, nocturia, burning in left pelvic area, pelvic pain shooting down left leg, adnexal tenderness, vaginal dryness, break through bleeding, delay in starting to pass urine, green (vaginal) discharge, vaginal odor and chills, loose suture in vault, irritative voiding symptoms, local infection of wound, leakage requiring daily pad use, abnormal urinary odor, permanent sensory neuropathy resulting in chronic pelvic pain, burning in vulva with radiation down her legs, low back pain, vaginal pain, symptomatic complex left ovarian cyst, significant adhesions involving the colon (large bowel) to the left pelvic sidewall, hypermobile urethra, and overactive bladder, required multiple nonsurgical and surgical interventions including antibiotics, anticholinergics, pain medications, muscle relaxants, cystoscopy with hydrodissection, bladder biopsy (x5), instillation of bladder agents and revision of previously placed (bard) sling on ((b)(6) 2012), anterior colporrhaphy with sacrospinous ligament suspension using a human dermal graft, vaginal mesh excision, diagnostic cystoscopy on (b)(6) 2013, robotic left salpingo-oophorectomy robotic enterolysis, robotic uterosacral ligament colposuspension right side, anterior colporrhaphy, posterior colporrhaphy with enterocele repair, sacrospinous ligament fixation (x2) sheets of human axis dermatological graft, cystoscopy, removal of adhesions involving the colon to the left pelvic sidewall on ((b)(6) 2015), interstim pne trial on ((b)(6) 2015), interstim permanent lead and generator implantation with complex programming and electronic analysis under fluoroscopic guidance on ((b)(6) 2015), tension free suburethral sling (biologic grafting ¿ coloplast) and cystoscopy on ((b)(6) 2015), bladder lavage and cystoscopy on ((b)(6) 2016), botox injection into the bladder on ((b)(6) 2016), post-implantation chronic constipation.

• Brand Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO
• Common Device Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9266126
• Report Number: 1018233-2019-06986
• Device Sequence Number: 11196331
• Product Code: OOD
• UDI-Device Identifier: 00801741016233
• UDI-Public: (01)00801741016233
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2019

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: 11/30/2012
• Device Model Number: BRD600HH
• Device Catalogue Number: BRD600HH
• Device Lot Number: HUUK0025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 73