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

Model Number BRD400HK

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

Patient Problems Micturition Urgency (1871); Discomfort (2330); Injury (2348)

Event Type  Injury  

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, which may occur following the implant procedure - temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the mesh sling implant - perforations or lacerations of vessels, nerves, bladder or any viscera, which may occur during introducer needle passage - transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion of the implant." (b)(4).

Event Description

The patients 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 suprapubic pain radiating to the lower back with bilateral groin discomfort upon lifting her son, urinary urgency, urinary frequency, urinary retention, nocturia, mild prolapse anteriorly, vaginal and suprapubic pain, spasms which occurred with activity such as menses, intercourse and at the end of the day.She had mild bilateral obturator internus discomfort and left mild-moderate ileococcygeus tenderness and spasm upon palpation during exam.Her lateral pelvic pain would radiate down her legs, as well as tenderness upon palpation to her inner thighs.Although she utilized pelvic floor therapy for htpfd, she underwent procedures such as a left pudendal block and peritoneal laparoscopy which discovered endometriosis.She is documented post-implant as having received d&c once for endometriosis.In 2013, the mesh was palpable and felt thicker on the right side, as if it was folded.She had more tenderness on the right side overlying the sling/periurethral pain, and hypersensitive skin at this area.She underwent five trigger point injections, then partial excision of the vaginal/urethral sling in (b)(6) 2013.After excision, she continued to experience right lower abdominal quadrant pain, pain over the incision site that radiated down the right leg, suprapubic pain when her bladder was full, occasional nocturia, urge incontinence, chronic dyspareunia, bladder spasm, evaluated for possible right sided obturator nerve injury or entrapment.She experienced excruciating tenderness on the right lateral vaginal wall where the sling was excised as well as some tenderness on the anterior vaginal wall.A small piece of mesh under the midurethra was palpable during exam which appeared to show some vaginal mucosa erosion.She complained of tingling upon light touch to her right medial thigh, numbness, and limb muscle weakness that interfered with ambulation.Her physicians felt she was having significant [obturator] nerve irritation/palsy on the right, lower back nerve damage, and mononeuritis of a lower limb.Underwent right obturator nerve blocks, more trigger point injections, and was recommended to use a vaginal dilator prior to intercourse.Additionally, she complained of left lower abdominal quadrant pain, bloating, diarrhea, irritable bowel syndrome, and red blood in her bowel movements.Discussion was made regarding possible neuroaugmentation therapy [spinal cord stimulator] if her symptoms did not progress with the injections and nerve blocks.She was recommended to see a mental health specialist to help with her coping mechanisms for her chronic condition and depression.Per additional information received on 07/18/2017, the patient has experienced stress urinary incontinence type two, pain, erosion, infection, unspecified urinary problems, unspecified bowel problems, recurrence, dyspareunia, unspecified neuromuscular problems, vaginal scarring, and required nonsurgical and additional surgical interventions.Per additional information received on 28jan2021, the patient has experienced abdominal pain, nausea, dysuria, flank pain, frequency, chronic pelvic pain, uui, ic.Recurrent uti, e.Coli, abdominal muscle spasms and swelling of her abdominal muscles, feeling something sharp like fish wire that comes and goes vaginally when she is manipulating her pelvic muscles to break her spasm, recurrent urinary tract infection, chronic pelvic pain, interstitial cystitis, urgency urinary incontinence, foreign body in the vagina, pelvic pain, mesh erosion, mesh exposure, asthma, pelvic cramping, ovarian cyst, dysmenorrhea, migraine, chronic pelvic pain, stress urinary incontinence, suprapubic pain, honeymoon cystitis, neuropathic pain, perineal pain, neuropathy, postoperative pain, pain in cervical spine, back pain, bladder spasm.Additionally the patient required non-surgical and surgical interventions.

• Brand Name: ALIGN TO URETHRAL SUPPORT SYSTEM - HOOK
• Type of Device: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK
• 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 11301577
• MDR Text Key: 230970730
• Report Number: 1018233-2021-80014
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016219
• UDI-Public: (01)00801741016219
• 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
• Report Date: 02/09/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: BRD400HK
• Device Catalogue Number: BRD400HK
• Device Lot Number: HUVD0857
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2011
• 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: 27 YR
• Patient Weight: 72