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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arrhythmia (1721)
Event Type  Injury  
Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. Linked mrds: 2029214-2019-00679, 2029214-2019-00680. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report the literature review of ¿cardiac arrest induced by carotid sinus reflex activation during flow-diverter stent deployment¿ (shunsaku goto, takashi izumi, masahiro nishihori, mamoru ishida, tetsuya ishida, masato otawa, tomoki kawaguchi, ryosuke oshima, asuka kropp, mizuka ikezawa, toshihiko wakabayashi). Case report: a (b)(6) woman was previously diagnosed with right multiple internal carotid artery (ica) aneurysms, and her status was yearly monitored as an outpatient. A coil embolization had been performed for the anterior choroidal artery aneurysm; after 6 months, the residual ica aneurysms were treated using ped deployment. She was started on double antiplatelet agents (clopidogrel 75 mg/day and aspirin 100 mg/day) beginning 14 days before intervention. Ped deployment was performed under local anesthesia via femoral puncture. She was intravenously administered pentazocine (15 mg) and hydroxyzine pamoate (25 mg) before the femoral puncture; afterward, she was administered dexmedetomidine hydrochloride 0. 3 g (after an initial loading of 5 g for 5 minutes) for mild sedation. An 8-french roadmaster (goodman, aichi, japan) was placed in the right cervical ica using a 6-french envoy (cerenovus, new brunswick, new jersey, usa) and 4-french hk inner catheter (hanako, saitama, japan). The marksman (medtronic) was triaxially advanced through a 5-french navien (medtronic). The navien was placed in the cavernous segment of the ica, and the marksman was then navigated to the second segment of the middle cerebral artery. The patient¿s blood pressure and heart rate at that time were 110/70 mm hg and 66 bpm, respectively. A pipeline flex (4 x16 mm) was inserted and deployed from the proximal end of the ica posterior communicating artery bifurcation. During the deployment, cardiac arrest occurred when the navien and marksman were pushed farther to promote adequate opening and apposition of the ped against the vessel wall and increase the neck coverage by the device. Immediately before the arrest, her blood pressure and heart rate were 90/50 mm hg and 60 bpm, respectively. By pulling the delivery system back down and reducing tension to the carotid sinus, a normal sinus rhythm was immediately restored; the cardiac arrest lasted approximately 30 seconds. The procedure resumed after administration of intravenous atropine (0. 5 mg), with care not to excessively push the system. Neither severe hypotension nor bradycardia were observed for the remainder of the procedure, and after successfully deploying the ped, a postoperative neurologic examination was negative. Because her modified rankin scale score was negatively affected, she was discharged on postoperative day 4.
 
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Brand NamePIPELINE FLEX
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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8759856
MDR Text Key150012527
Report Number2029214-2019-00681
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-400-16
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 Received06/17/2019
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: 07/03/2019 Patient Sequence Number: 1
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