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

Model Number UNK-NV-MARATHON

Device Problem Burst Container or Vessel (1074)

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Unspecified Nervous System Problem (4426); Embolism/Embolus (4438)

Event Date 01/27/2022

Event Type  Injury  

Event Description

Xiwu zhang, gang zhao, che jiang, and zhuang chen; journal of vascular and interventional radiology; 2022; (22)01061-2; double stent retriever mechanical embolectomy of a refractory onyx embolus in the basilar artery; https://doi.Org/10.1016/j.Jvir.2022.07.0 medtronic received information in a literature article about compilations arising from a patient treated with onyx 18 embolization, marathon catheter, and solitaire (sr) stents. a 24-year-old male was admitted with a headache and blurry vision for 2 days. computed tomography (ct) scan of the head showed cerebral hemorrhage in the left occipital lobe, and digital subtraction angiography showed an arteriovenous malformation (avm) in the left occipital lobe, supplied by the left posterior cerebral artery (pca). the patient was treated with embolization of the avm under general anesthesia.During embolization, the marathon microcatheter ruptured and onyx-18 blocked the mid and superior portions of the basilar artery (ba). an emergency mechanical embolectomy was performed.No vasodilator was given.The microcatheter was removed and a sr (solitaire fr, 6*30mm) was deployed from the right pca to the ba through an intracranial support catheter (navien 072, microtherapeutics) and a microcatheter (rebar 27, microtherapeutics).The sr was withdrawn 3 minutes later under continuous aspiration with the support catheter, and the embolus was partially removed with the sr, with part remaining in the v3 segment of the left vertebral artery (va).On the second attempt to remove the residual embolus from the left va, the embolus embolized distally to the apex of the ba.Subsequently, the support catheter was introduced to the apex of the ba for direct aspiration of the embolus.However, the embolus could not be aspirated, nor could it be firmly attached to the catheter tip and removed.A combination of sr and aspiration was then performed.The embolus moved slightly with the sr, but shortly detached.Finally, a double sr technique was employed.The first sr was deployed from the right pca to the ba.The microcatheter (rebar 27) was removed and introduced into the left pca, in order to deploy the second sr from the left pca to ba.The two srs were pulled simultaneously to ¿clamp¿ the embolus.Then the entire system -- the navien 072 catheter and the two srs and the clamped embolus -- was pulled out as a whole.The onyx embolus was successfully removed.Blood flow to the ba and its branches was restored 110 minutes after microcatheter rupture.The avm embolization was then completed as planned.The patient awakened from anesthesia with weakened motor strength (grade 3) and hemidysesthesia of the left upper and lower limbs.Unenhanced ct revealed infarction in the right side of the pons, and scattered intracranial high-density foci of embolized onyx fragments.No antiplatelet or anticoagulant therapy was given.After 10 days of rehabilitation, the patient's left limb strength recovered to grade 4 and he was discharged.At 15 months, the patient returned with normal strength and slight numbness in the left upper limb.Cerebral angiography showed patent blood flow in all branches of the basilar artery and no residual avm.License information: 105-7100-060 we got no license information for this product.License information: unk-nv-marathon we got no license information for this product.License information: unk-nv-srd we got no license information for this product.Sold date: refer to sap expiration date: refer to sap zuol2 2022-08-05.

Manufacturer Narrative

Event related to regulatory report#: 2029214-2022-01303.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.

Manufacturer Narrative

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.

Event Description

Additional information received reported that after searching, it was confirmed that the operation date was (b)(6) 2020.The consumables used in the operation were attached.The suspected product was marathon, and the lot number was b034435.The situation at that time was that the onxy glue had not come out of the marathon catheter tip.The catheter was found to be broken, causing onxy glue to spill out of the middle of the catheter.

• 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: 15172094
• MDR Text Key: 297315415
• Report Number: 2029214-2022-01304
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 08/19/2022
• 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
• Patient Age: 24 YR
• Patient Sex: Male