MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES -3004086170 PELVILACE TO BIOURETHRAL SUPPORT W/HALO NEEDLE

Catalog Number 482152

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

Patient Problems Incontinence (1928); Hernia (2240); Prolapse (2475)

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: potential complications associated with the proper implantation of the pelvilace¿ to 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 implant perforations or lacerations of vessels, nerves, bladder or bowel, which may occur during needle passage.Transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion at the implant site.(b)(4).The total number of events for product classification code pag is 3.Qty 2-pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.Qty 1- pelvilace to biourethral support system needle and implant hook needle 50cm.The information provided by bard 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 bard.Sample not received.

Event Description

Per additional information received, the patient has experienced mild hypertrophic degenerative facet disease, rectal pain and spasms, changes in bowel habits with urgent bowel movements, otc enzyme use, history of exposure to blood borne pathogens in setting of a medical establishment, one episode of explosive bowel movement, sudden onset of multiple pelvic floor symptoms, abnormal ct scan demonstrated small bowel loops in the perirectal fat, enterocele, which is causing obstruction of the rectum, upon straining-enterocele enlarges in size, leakage and urinary incontinence, feeling a mass or lump in her vaginal area, sometimes feels like rectum is protruding out, rectocele, cystocele, mild anxiety, gerd and takes nexium irregularly, moderately overweight, recurrence of hyperthyroidism suppressing tsh, significant bladder outlet obstruction, severe boring pain in her rectum (proctalgia fugax-pelvic floor muscle spasms), restless leg syndrome, vaginal prolapse, intermittent sporadic urinary incontinence, intermittent soiling of a small amount of formed stool, and dyspareunia to the point that she is currently unable to have intercourse.Examination showed atrophic changes, early enterocele and a combination of a high rectocele.The anterior vaginal wall was completely supported, no evert evidence of any mesh erosion within the vagina.Palpation of the vagina showed a concentration of mesh along the mid upper posterior vaginal wall.Patient would potentially benefit from vaginal estrogen.She continued with not completely emptying her rectum, unable to have intercourse due to discomfort with reports of feels as if her partner is hitting something painful.She also reported pain in right upper quadrant, lower chest, twisting or a swelling sensation, swelling in general in the tissues as well as in her lower extremities, water pill sometimes helps with the sensation in her right upper quadrant.The patient continued to report a golf-ball-like feeling in the vagina and some degree of incontinence, (b)(6) 2009 grade four enterocele with apex descent through the middle of the supported vagina, through the cylinder formed by anterior and posterior meshes, robotic sacrocolpopexy was recommended.She reported incontinence and urge to void during the night, sometimes en route leakage.She was noted to have three hernia repairs in 2009.On (b)(6) 2009, the patient had robotic sacrocolpopexy with polypropylene mesh and periurethral injection on (b)(6) 2009, at that time vaginal vault examination showed complete support.In 2011 she complained of upper abdominal pain that tended to radiate around the right side and into the back.She had minimal liver profile changes and it was suspected she had capsular distention secondary to fatty liver, hyperlipidemia, 2012 worsening rlq pain, positive caffeine use, noted to be on weight watchers and having trouble losing weight, somatic dysfunction of the head region, rib cage, abdomen, cervical region, thoracic region, lumbar region, pelvic region, lower extremities, chronic stress, swelling, leg pain, genital herpes and chronic non-alcoholic liver disease, 2013 bladder was uncomfortable, had pelvic pressure and discomfort, possible uti, headaches, mixed hyperlipidemia, unspecified vitamin d deficiency and elevated fasting glucose.

• Brand Name: PELVILACE TO BIOURETHRAL SUPPORT W/HALO NEEDLE
• Type of Device: PELVILACE TO BIOURETHRAL SUPPORT W/HALO NEEDLE
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES -3004086170; astley lane industrial estate; unit 1; swillington, leeds LS26 8XT; UK LS26 8XT
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES -3004086170; astley lane industrial estate; unit 1; swillington, leeds LS26 8XT; UK LS26 8XT
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5494522
• MDR Text Key: 40128211
• Report Number: 1018233-2016-00264
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/11/2016

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: 03/31/2010
• Device Catalogue Number: 482152
• Device Lot Number: CVRH0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2007
• 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: AVAULTA PLUS BIOSYNTHETIC SYSTEM-ANTERIOR
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR