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

Model Number UNK-NV-MICROCATH

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

Patient Problems Cardiac Arrest (1762); Visual Disturbances (2140); Cognitive Changes (2551); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 07/14/2020

Event Type  Death  

Event Description

Kulanthaivelu, k., pendharkar, h., prasad, c., kumar gupta, a., hanumanthapura ramalingaiah, a., saini, j., <(>&<)>amp; srinivas, d.(2020).Anterior cranial fossa dural arteriovenous fistulae ¿ angioarchitecture and intervention.Clinical neuroradiology, 31(3), 6 61¿669.Https://doi.Org/10.1007/s00062-020-00932-z summary: anterior cranial fossa (acf) dural arteriovenous fistulae (davf) are rare, unique, and ominous.While surgical disconnection is considered as the favored management option, endovascular treatment has latelygained importance.We present a single institution experience of seven cases.Identified event: a (b)(6) male had sudden onset swaying; 15 days back; giddiness; blurred vision.The angio result showed partial occlusion.An emergent decompressive hinge craniotomy was performed with ligation of the vein and evacuation of the hematoma.Following a decompressive craniotomy, the patient had fixed dilated pupils, with a glasgow coma scale (gcs) score of e1vtm1.Follow-up ct revealed multiple progressive hypodensities in the bilateral cerebral hemispheres, suggestive of infarcts due to vascular compression with ongoing mass effect.The patient died following a sudden cardiac arrest 5 days later.Devices used: neuronmax-navien-marathon co-axial system.

Manufacturer Narrative

Kulanthaivelu, k., pendharkar, h., prasad, c., kumar gupta, a., hanumanthapura ramalingaiah, a., saini, j., <(>&<)>amp; srinivas, d.(2020).Anterior cranial fossa dural arteriovenous fistulae ¿ angioarchitecture and intervention.Clinical neuroradiology, 31(3), 6 61¿669.Https://doi.Org/10.1007/s00062-020-00932-z.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NV MICROCATHETER
• 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: 13579798
• MDR Text Key: 285997952
• Report Number: 2029214-2022-00260
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2022

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-MICROCATH
• Device Catalogue Number: UNK-NV-MICROCATH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/22/2022
• 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): Death
• Patient Age: 64 YR
• Patient Sex: Male