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

Model Number 5195102400

Device Problems Material Fragmentation (1261); Device Operates Differently Than Expected (2913); Migration (4003)

Patient Problems Unspecified Infection (1930); Nausea (1970); Pain (1994); Sepsis (2067); Vomiting (2144)

Event Date 11/16/2012

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with a coloplast transvaginal mesh device.Later patient suffered an infection that led to sepsis.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up was created to document the updated device information, corrected implant date, patient information, updated method codes and conclusion of the investigation.The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

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, the patient suffered an infection that led to sepsis, causing damages.On or about (b)(6) 2012, the patient became ill as a result of implantation of the device.Additional information received further reported that in (b)(6) 2012, the patient was hospitalized with flu-like symptoms, nausea, vomiting, diarrhea, foul smelling urine, no urine output for over 12 hours, and abdominal cramping/pain.The patient experienced urosepsis positive for escherichia coli (e.Coli), acute renal failure secondary to acute tubular necrosis and interstitial nephritis (it was noted this would require outpatient dialysis), severe dehydration, iron deficiency anemia, thrombocytopenia, pyuria, recurrent urinary tract infections (utis), interstitial nephrosclerosis, stage four chronic kidney disease, and mild bilateral perirenal stranding.The mesh was suspected as a contributing factor to the recurrent utis.Utis occurred before and after the mesh was explanted, and were positive for: mixed gram positive flora, klebsiella oxytoca, enterococcus faecalis, coagulase-negative staphylococci, methicillin-resistant staphylococcus aureus (mrsa), mixed gram negative flora, citrobacter freundii, klebsiella pneumoniae, and group b streptococcus.The patient experienced utis/pyelonephritis when off antibiotics; uti was also noted while the patient was taking prophylactic antibiotics.Bacterial seeding of the mesh was suspected.In (b)(6) 2013, a cystoscopy was normal.Renal ultrasound found bilateral renal cortical irregularity and atrophy.The patient also experienced mixed urinary incontinence, vaginal pain, dyspareunia, post void residual of 209ml, bilateral hip pain, myofascial pain, vaginal discharge, and urinary frequency.It was noted that chronic kidney disease with interstitial nephritis was due to urosepsis from utis related to the mesh.The mesh was infiltrating the vaginal wall.The patient had no evidence or symptoms of uti prior to mesh placement.In (b)(6) 2014, a pelvic/transabdominal/transvaginal ultrasound was normal.It was reported that the mesh might be responsible for some of the patient's discomfort.The patient also experienced obstructive voiding symptoms.In (b)(6) 2015, there was no evidence of mesh erosion into the vaginal wall, bladder, or urethra.Translabial ultrasound found probable discontinuous mesh segments.The patient also experienced urinary urgency.In (b)(6) 2015, the patient noted she was told the mesh migrated and eroded into the vaginal wall and into the urethra, which led to recurrent utis.She was looking forward to mesh removal; however, this also provoked anxiety given her past medical problems and history of renal failure.The mesh was completely excised.Intraoperative findings: deep mesh infiltration into urethral wall without penetration, mesh fixed to periosteum of pubic bone.Benign fibrous tissue and skeletal muscle - multiple tan-red soft tissue-covered mesh fragments.Following excision of the mesh, the patient experienced dysuria, microscopic hematuria, burning sensation/bleeding with intercourse, and urinary tract infections.Bilateral hip pain persisted but improved following mesh excision.It was noted the hip pain was likely secondary to nerve damage from the prior mesh implant.The patient underwent pubovaginal sling implant in (b)(6) 2015.Adhesions of the urethra and bladder neck to lateral pelvic wall were identified and removed.Further information received reported that a cystoscopy noted trigone squamous metaplasia, but was otherwise normal.The patient also experienced vaginal atrophy.

• Brand Name: ARIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek 3050, dk; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 4358180
• MDR Text Key: 5175901
• Report Number: 2125050-2014-00441
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2022

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: 5195102400
• Device Catalogue Number: 519510
• Device Lot Number: AK090052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: 11/24/2014; 02/28/2022
• Supplement Dates FDA Received: 03/19/2020; 09/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Female