MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MARATHON

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

Patient Problems Bacterial Infection (1735); Hair Loss (1877); Unspecified Infection (1930); Thrombosis/Thrombus (4440); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)

Event Date 05/01/2006

Event Type  Injury  

Event Description

Palioura s, gobin p, brodie s, marr b, dunkel i, abramson d.Ophthalmic artery chemosurgery for the management of retinoblastoma in eyes with extensive (>50%) retinal detachment.Wiley periodicals.2012;59:859¿864.Doi: 10.1002/pbc. the purpose of this study was to evaluate the efficacy of ophthalmic artery chemosurgery for retinoblastoma associated with >50% retinal detachment. retrospective review of 37 eyes of 34 retinoblastoma patients who had extensive (>50%) bullous non-rhegmatogenous retinal detachments and received ophthalmic artery chemosurgery either as primary treatment or as ¿¿salvage¿¿ treatment after failed multi-cycle intravenous chemotherapy and/or external beam radiation (mean follow-up, 21 months).Data on patient and ocular survival, complications of ophthalmic artery chemosurgery treatments, time course of retinal reattachment, and serial electroretinograms (erg) were collected.The database of all patients with retinoblastoma included 125 eyes in 99 patients treated with ophthalmic artery chemosurgery from (b)(6) 2006 to (b)(6) 2010.They identified 37 eyes of 34 patients (10 boys, 24 girls) 3 months to 5.4 years old (mean, 21 months; median, 14 months) who prior to ophthalmic artery chemosurgery had advanced intraocular retinoblastoma and >50% bullous non-rhegmatogenous retinal detachment.Disease was unilateral in 20 patients and bilateral in 14.A total of 134 ophthalmic artery chemosurgery injections were performed.All children survived.Five eyes (5/37; 14%) were enucleated for progression of disease.The kaplan¿meier enucleation-free survival rate at 2 years was 87.9%.The retina reattached in 28 eyes (28/37; 76%) and the 30-hz flicker ergs improved by >25 mv in seven eyes (7/37; 19%), remained stable (change > 25 mv) in 26 eyes (26/37; 70%), and decreased by >25 mv in four eyes (4/37; 11%).The kaplan¿meier retinal reattachment rate was 58% after 3 months and three ophthalmic artery chemosurgery infusions.A total of 134 ophthalmic artery chemosurgery procedures were performed (range, 2¿7; mean, 3.6 per eye; median, 3 per eye).Regarding procedural complications, bronchospasm occurred a total of 16 times; when severe, iv epinephrine bitartrate was given.Upon bronchospasm resolution catheterization was resumed.Three patients developed an allergic reaction to iodinated contrast and were appropriately premedicated in subsequent procedures.No stroke, seizure, or femoral artery occlusion was observed.Nine eyes developed temporary periocular erythema in the distribution of the supra-orbital or supra-trochlear artery.Two eyes developed a temporary inflammatory syndrome with periocular edema and redness.Four eyes developed short-lived eyelash thinning or loss along the medial third of the upper eyelid.One eye that was treated with ophthalmic artery chemosurgery and additional radioactive plaque therapy developed an avascular retinopathy and is now in phthisis.Three eyes with longstanding tractional retinal detachments developed cataracts (without trauma or radiation).Twenty-five ophthalmic artery chemosurgery infusions resulted in chemotherapy-induced grade 3 or 4 neutropenia in 14 patients and two infusions resulted in grade 3 anemia in one patient.Toxicity developed mostly when the total dose of melphalan exceeded 0.4 mg/kg of body weight.Neutropenia was grade 3 (absolute neutrophil count 500¿1,000/mm3) in 21 cases and grade 4 (absolute neutrophil count > 500/mm3) in four cases.One patient developed neutropenic fever that required hospitalization the article does not state any technical issues during use of the marathon catheter. the following intra- or post-procedural outcomes were noted:  bronchospasm periocular erythema edema and redness eyelash thinning or loss retinopathy and is now in phthisis cataracts neutropenia anemia neutropenic fever.

Manufacturer Narrative

Palioura s, gobin p, brodie s, marr b, dunkel i, abramson d.Ophthalmic artery chemosurgery for the management of retinoblastoma in eyes with extensive (>50%) retinal detachment.Wiley periodicals.2012;59:859¿864.Doi: 10.1002/pbc. 21 months is the average age of the patients who used marathon devices in the study.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15202019
• MDR Text Key: 297684294
• Report Number: 2029214-2022-01339
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2022

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: Health Professional
• Device Model Number: UNK-NV-MARATHON
• Device Catalogue Number: UNK-NV-MARATHON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/10/2022
• 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; Hospitalization
• Patient Age: 21 MO
• Patient Sex: Female