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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Intracranial Hemorrhage (1891); Muscle Weakness (1967); Embolism/Embolus (4438)
Event Date 10/08/2020
Event Type  Injury  
Manufacturer Narrative
Kühn al, satti sr, eden t, et al. Anatomic snuffbox (distal radial artery) and radial artery access for treatment of intracranial aneurysms with fda-approved flow diverters. Ajnr american journal of neuroradiology. 2021;42(3):487-492. Doi:10. 3174/ajnr. A6953. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Kühn al, satti sr, eden t, et al. Anatomic snuffbox (distal radial artery) and radial artery access for treatment of intracranial aneurysms with fda-approved flow diverters. Ajnr american journal of neuroradiology. 2021;42(3):487-492. Doi:10. 3174/ajnr. A6953 medtronic literature review found a report of patient complications in association with a pipeline embolization device and phenom plus/phenom 27 catheters. The purpose of this article was to present experience with transradial (distal radial/anatomic snuffbox and radial artery) access as an alternative to femoral artery access for treatment of intracranial aneurysms using all 3 fda-approved flow diverters. Seventy-four patients (64 female) were included in the article, with a mean age of 57. 5 years. A pipeline device was used in 65 of the 74 procedures. The following intra- or post-procedural outcomes were noted: - 3 cases (4. 1%) required conversion to femoral access due to tortuous anatomy and limited support of the catheters in 2 cases and an inability to navigate the catheters to the target vessel in a patient with an aberrant right subclavian artery. - 2 patients showed a smallamount of subarachnoid hemorrhage (sah) on postprocedural head ct. One of these patients had mild headache but was neurologically intact. The other patient showed new right-arm weakness on awakening from anesthesia and was brought back to the angiography suite where hyperacute platelet aggregation within the stent was identified and successfully treated with intra-arterial eptifibatide. The patient fully recovered within 6 months with an mrs of 0. In one patient acute clot formation was encountered during placement of the flow diverter, which was immediately treated with intra-arterial eptifibatide. Asymptomatic radial artery occlusion was encountered in 1 case (3. 7%). The initial procedure in this patient was performed via the radial artery (volar access) with a spasmolytic cocktail consisting of 2. 5mg of verapamil and nitroglycerin, 100mcg. Follow-up angiography in this patient was performed via the ulnar artery.
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12424691
MDR Text Key271467946
Report Number2029214-2021-01110
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2021
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: 09/03/2021 Patient Sequence Number: 1
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