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

Model Number 5195512400

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Emotional Changes (1831); Erythema (1840); Fatigue (1849); Foreign Body Reaction (1868); Itching Sensation (1943); Pain (1994); Scar Tissue (2060); Sepsis (2067); Skin Erosion (2075); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Dysuria (2684); Constipation (3274); Genital Bleeding (4507); Rectovaginal Fistula (4509); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced abnormal vaginal discharge and bleeding, erosion of the device into her vaginal cuff, recurrent urinary incontinence, abdominal and vaginal pain, recurrent urinary tract infections, fatigue, vaginal odor, foreign body reaction, and other injuries.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.H6 code a01 "patient device interaction problem" applied to capture the reported "concern that mesh is adherent to the bowel.".

Event Description

Additional info received on 10/16/2022- (b)(6) 2014.Continues to leak.Wears 4 pads daily.Does not feel any improvement with surgery.Physical exam noted.1 mm palpable mesh proximal vagina.No mesh visualized.Started on an anticholinergic to help with incontinence.(b)(6) 2014.Uti.(b(6) 2020.Vaginal bleeding -pelvic ultrasound showed nonspecific, small, somewhat prominent, nonvascular tubular structure in the left adnexa.(b)(6) 2021.Yellow-brown vaginal discharge; sometimes has air coming from vagina; occasional blood per rectum when wiping; some urinary frequency; acute cystitis without hematuria, possible colovaginal fistula.Colonoscopy planned.(b)(6) 2021.Ct abdomen/pelvis done for abdominal pain.Results showed questionable colovaginal fistula.02/04/2021.Abnormal urinalysis - protein 30 mg/dl, leukocyte esterase 1+, wbc 25-50 per hpf, bacteria 1+, squamous epi cells 6-30 per lpf.(b)(6) 2021.Continues to have yellow vaginal and rectal drainage.(b)(6) 2021.Urine culture > 100,000 cfu/ml e.Coli.(b)(6) 2021.Transvaginal ultrasound shows possible vaginal fistula.(b)(6) 2021.Urine culture > 100,000 cfu/ml e.Coli.(b)(6) 2021.Persistent vaginal drainage and anal seepage - physical exam notes small amount of pooling of yellow turbid fluid near the introitus with small fistula opening.Examination limited due to being uncomfortable for claimant.(b)(6) 2021.Urine culture >100,000 cfu/ml e.Coli, esbl positive.(b)(6) 2021.Rectovaginal fistula ¿ surgery planned documented.(b)(6) 2021.Recurrent infections, possible rectovaginal or anal vaginal fistula (b)(6) 2021.Pelvic exam under anesthesia, small excision exposed of exair mesh intraoperative findings: no evidence of a rectovaginal fistula or anal vaginal fistula: however, synthetic mesh is exposed at the apex of the vagina.The patient has moderate to large cystocele and a urethral caruncle.Vaginal voiding witnessed during examination.Pathology report: diagnosis - mesh, removal (gross examination only) the specimen consists of 3 gray-white polymeric roughened ragged portions of mesh ranging from 0.9 x 0.3 x 0.1 cm to 1 x 0.7 x 0.1 cm.No tissue is submitted for microscopic evaluation.(b)(6) 2021.Urine culture >100,000 cfu/ml e.Coli.(b)(6) 2021.Mesh erosion at the vaginal cuff suture line, palpable and tender to palpation across the anterior portion of the vaginal cuff.Vaginal discharge is thick, mustard like in consistency from the vagina and rectum.Intermittent shooting vaginal pain.Notes claimant has had 5 utis this year.Bladder botox seems to be the only thing that has help with pain.Last performed 6 months ago [no report available].Referred to urogynecology.(b)(6) 2021.On physical exam, only 1-2 fibers of mesh felt with palpation.Clinically not significant.Slight erythema at the apex.The arms of the mesh were palpable going out to the sacral spinous ligaments on either side but were not tender or exposed.No indication for removing the mesh at present time.(b)(6) 2021- (b)(6) 2021.Urine culture positive for e.Coli and pseudomonas aeruginosa.Prescribed cipro and macrobid.(b)(6) 2022.Urine culture >100,000 cfu/ml e.Coli, esbl, mdr.(b)(6) 2022.Cystoscopy with bilateral retrograde pyelograms was negative for abnormalities or filling defects [full report not available].(b)(6) 2022.Continues to have intermittent shooting vaginal pains and intermittent vaginal discharge which appears like mustard.Noted to have 8 culture-positive utis in the past 12 months.Mui.Physical exam notes a small area of granulation tissue at the center of the vagina at the apex and the tissue is mildly thickened on the left side.No mesh exposure or palpated.(b)(6) 2022.Urine culture >100,000 cfu/ml e.Coli, esbl, mdr.(b)(6) 2022.Abnormal urinalysis - leukocyte esterase 1+, wbc > 50/hpf, bacteria 1+/hpf.(b)(6) 2022.Vaginal pain, fluid collection near left vaginal apex.Mr pelvis report showed gas is seen along the vaginal cuff but no convincing evidence of colovaginal fistula.Subtle findings raise suspicion for rectovaginal fistula.Mri recommended for further evaluation.(b)(6) 2022.Urine culture >100,000 cfu/ml e.Coli, esbl, mdr.(b)(6) 2022.Recent culture positive for e.Coli.Concern that mesh is adherent to the bowel.Urogynecology to have discussion with colorectal surgery to create a formal plan.(b)(6) 2022.Urine culture >100,000 cfu/ml e.Coli, esbl, mdr.(b)(6) 2022.Exposed mesh with possible colovaginal fistula.(b)(6) 2022.Telehealth appointment with colorectal surgeon to discuss upcoming combined surgery with urogynecology for mesh excision.Still concerned for an undetected fistula.Claimant reports occasional gas per vagina.

Manufacturer Narrative

Correction: health impact code.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.¿ devices met specification prior to release and no trends were noted.

Event Description

Additional information received 3/6/2023 as follows: between 1/27/2015 and 11/8/2022 the patient has experienced abdominal pain, vaginal itching, intermittent constipation, vaginal scarring, hospital admission for sepsis followed by a rash.

Event Description

Additional information received on 2/4/2023 indicates that the patient underwent an additional removal surgery on (b)(6) 2022.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 14781035
• MDR Text Key: 294676393
• Report Number: 2125050-2022-00641
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• 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,Followup,Followup
• Report Date: 03/09/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 4031356
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 10/16/2022; 10/16/2022; 02/04/2023; 03/06/2023
• Supplement Dates FDA Received: 10/26/2022; 11/07/2022; 02/10/2023; 03/09/2023
• Date Device Manufactured: 02/26/2014
• 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: 79 YR