MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR KIT; SURGICAL MESH

Model Number 5195501400

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Scar Tissue (2060); Urinary Retention (2119); Discomfort (2330); Dysuria (2684)

Event Type  Injury  

Manufacturer Narrative

Lot number: ak060032.This event was previously reported via alternative summary report on 19dec2018, exemption number e2014015.This report is intended to be a follow-up report to submit additional information that has been received.

Event Description

Additional information received further reported that in (b)(6) 2017 the patient had experienced or was experiencing mesh extrusion at the vaginal wall.

Event Description

Additional information received further reported that on the following dates the patient had experienced or was experiencing the following: (b)(6) 2017: mesh material 5 cm from introitus along the posterior vaginal wall protruding into the vaginal lumen slightly eccentric to the left side.(b)(6) 2017: ct cystogram showed tiny hyperdensity posterior to bladder.Dyspareunia.(b)(6) 2017: dysuria, (b)(6) 2018: sui, (b)(6) 2019: vaginal discharge, (b)(6) 2021: stress incontinence, urinary retention, (b)(6) 2021: mild scarring at anterior vaginal wall, (b)(6) 2021: mild vaginal discharge, (b)(6) 2021: urinary incontinence, vaginal discomfort.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, additional information received on 09/15/2021.(b)(6) 2017: mesh exposure, dyspareunia, vaginal discharge, vaginal bleeding.(b)(6) 2017: mesh extrusion, bladder defect, vaginal prolapse, vaginal bleeding, vaginal pain.(b)(6) 2017 - (b)(6) 2018: incontinence.(b)(6) 2018: vesicovaginal fistula (vvf).Harvest of fascia lata, placement of fascial sling, transvaginal vesicovaginal fistula repair x2 (bilateral), placement of acell biological graft, anterior vaginal wall reconstruction, cystoscopy w/ureteral catheterization (bilateral) [no operative report].(b)(6) 2018: persistent leaking using 1 pad every 4-6 hours.(b)(6) 2018: persistent leaking, assumed continued vesicovaginal fistula (vvf).(b)(6) 2018: vvf at the mid-anterior vaginal wall (left lateral sulci), vvf at the distal anterior vaginal wall (at the midline), vvf at the mid-anterior vaginal wall (right lateral sulci), although this was hard to discern, did not see any apical fistula (cervix in place).(b)(6) 2018: complication of implanted vaginal mesh, sequela, mixed stress and urge urinary incontinence, vaginal atrophy.(b)(6) 2018: 3-4 mm fistulous tracts (2 of them) directly at the posterior bladder neck.(b)(6) 2019: robotic assisted laparoscopic vesicovaginal fistula repair, placement of acell biological graft, placement of suprapubic tube, cystoscopy with bilateral ureteral stent placement [no operative report].(b)(6) 2019: uti, yeast infection.(b)(6) 2019: sequela, mixed stress and urge urinary incontinence.(b)(6) 2019: resolution of vesicovaginal fistula, leaking only a small amount upon standing.(b)(6) 2020: pin point fistula at 6 o¿clock posterior bladder neck.(b)(6) 2021: transvaginal partial cystectomy, creation of martius flap, placement of acell biological graft, and cystoscopy with suprapubic tube placement [no operative report].No other adverse patient effects were reported.

Manufacturer Narrative

This event was previously reported via alternative summary report on (b)(6) 2018, exemption number (b)(4) and follow-up report to 2125050-2021-01285.According to the available information, the patient's legal representative stated extreme pain, discomfort, urinary problems, dyspareunia and underwent multiple corrective surgeries to remove or revise part of the pelvic mesh device.Aris was implanted on (b)(6) 2010.Corrective action: management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type relating to the reported complaints are captured in the product risk documentation.Based on this, and because the device is not available for evaluation, no further corrective action is required at this time.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12450640
• MDR Text Key: 270764771
• Report Number: 2125050-2021-01285
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2021

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: Lay User/Patient
• Device Model Number: 5195501400
• Device Catalogue Number: 519550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 09/15/2021; 11/20/2021
• Supplement Dates FDA Received: 11/10/2021; 12/15/2021
• 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: 48 YR
• Patient Sex: Female