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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REFLEX CATHETER CATHETER, PERCUTANEOUS

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MICRO THERAPEUTICS, INC. DBA EV3 REFLEX CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number UNK-NV-RFX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Intracranial Hemorrhage (1891); Unspecified Nervous System Problem (4426)
Event Date 07/31/2019
Event Type  Injury  
Event Description
James yeomans, lilian sandu, and anand sastry; the neuroradiology journal; 2020; 33(6) 471¿478; pipeline flex embolisation device with shield technology for the treatment of patients with intracranial aneurysms: periprocedural and 6 month outcomes; doi: 10. 1177/19 71400920966749journals. Sagepub. Com/home/neu. Medtronic received information in a literature article that complication including stroke, dissection, and foreshorting occurred with third generation pipeline flex with shield and navien catheter.   this prospective, single-arm study reviewed a total of 31 patients (26 patients were women) with 32 aneurysms, 28 of which were treated electively and four of which were treated acutely, over a 21-month time period between 1 october 2017 and (b)(6) 2019 at a tertiary centre for interventional neuroradiology.  the pipeline shield is supplied in multiple sizes, from 2. 5mmx10mm to 5mmx35 mm. Pipeline sizing is aided by the use of the software application sim size.  the mean age of the cohort was 58. 8 years. The elective cases received dual antiplatelet therapy post-procedure. The acute cases received single antiplatelet therapy post-procedure. Of the target aneurysms, 16/32 (50%) were small 10 mm), 13/32 (41%) were large (10¿25 mm) and 3/32 (9%) were giant (> or
=
25 mm). There were three aneurysms treated with a second pipeline shield device due to fore-shortening of the first device post-deployment or suboptimal neck coverage.  there was no post-procedure mortality in the series.  however, one patient had a hemorrhagic stroke affecting the left-sided basal ganglia and left temporal lobe.  the stroke occurred during a complex procedure.  the patient presented with a wide-necked 20mm x15mm left posterior communicating artery aneurysm.  a navien catheter was advanced to the left internal carotid artery (ica). The left ica was dysplastic and narrowed in several segments. Two pipeline shield devices were deployed across the neck of the aneurysm. The second device was required due to immediate foreshortening of the device and subsequent migration following angioplasty.  the aneurysm was coiled through an echelon microcatheter. Attempts to widen the dysplastic left ica led to the formation of a traumatic left carotico-cavernous fistula.  the patient woke up with a right-sided neurological deficit. Ct imaging demonstrated a left-sided basal ganglia and left temporal lobe intracranial hemorrhage, probably secondary to wire perforation. A ct angiogram showed the pipeline device remained patent and correctly sited. The patient underwent neurorehabilitation and had moderate disability.   another patient experienced a dissection which occurred during an elective procedure.  this patient underwent flow diversion of a large 8mmx10mm right posterior communicating artery recurrence that had previously been coiled twice. There was a small clot at the distal end of the pipeline device due to poor opposition. The distal end of the device was balloon angioplastied with good apposition. During this maneuver, there was dissection of the petrocavernous segment of the ica by the advancing tip of the intermediate catheter. A single solitaire stent  sized 6mmx30mm was deployed across the dissection, reopening the vessel. The patient woke up with no new neurological deficits.
 
Manufacturer Narrative
See attachments for literature article. Event related to regulatory report: 2029214-2022-00168. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameREFLEX CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
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 Key13476725
MDR Text Key288797139
Report Number2029214-2022-00169
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK-NV-RFX
Device Catalogue NumberUNK-NV-RFX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/07/2022 Patient Sequence Number: 1
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