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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-25
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Patient Problems Neuropathy (1983); Therapeutic Response, Decreased (2271)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received the following report through literature review of ¿delayed posttreatment residual flow into aneurysm after flow diverter placement¿. A (b)(6) woman presented with a 28-month history of diplopia. Neuro-ophthalmologic tests revealed right oculomotor nerve palsy. Dsa revealed a large intracranial aneurysm measuring 23. 0 _ 18. 1 mm in the cavernous segment of the right internal carotid artery (ica). Seven days before the operation, the patient was started on oral doses of 100 mg aspirin and 75 mg clopidogrel per day. Aspirin reaction unit was 468 seconds, and p2y12 reaction units was 167 seconds, demonstrating the absence of any aspirin or clopidogrel resistance. Coaxial endovascular navigation under general anesthesia. A 7-french guiding sheath (shuttle sheath) was placed in the proximal cervical segment of the ica, and a 6-french navien was placed in the proximal intracranial segment of the ica. A 0. 027 marksman was place with the aid of 0. 014 chikai. A ped 4. 75 _ 25 was delivered. The delivery microcatheter was then moved over the delivery wire to the distal edge of the ped, and the delivery wire was exchanged for a 0. 010-inch outer diameter, 300-cm-x-celerator. The delivery microcatheter was exchanged for a hyperform 7_7mm, to perform balloon angioplasty to expand the ped and fix the stent along the arterial wall. Post procedure, dsa demonstrated flow stagnation inside the aneurysm dome. The postoperative course was uneventful, and the patient was discharged 9 days post procedure without new neurologic deficits. A 6-month follow-up dsa demonstrated delayed post-treatment residual flow into the aneurysm sac. No stent migration was observed. Although she was scheduled for additional fd placement because of concern for aneurysmal rupture, the operation was not conducted due to an interim motor vehicle accident. Oral treatment with aspirin (100 mg/day) and clopidogrel (75 mg/day) were continued during her recovery. A dsa conducted 12 months post fd treatment showed that the aneurysm had completely thrombosed. Right oculomotor nerve palsy had partially resolved. This case showed 2 key findings. First, dsa 6 months post procedure demonstrated delayed post-treatment residual flow into the aneurysm that was not observed following the initial procedure. Second, there was complete thrombosis of the aneurysm12 months after the fd treatment, despite the delayed posttreatment residual flow observed 6 months earlier. Follow-up dsa 7 days post procedure revealed partial thrombosis of the aneurysm with new post-treatment residual flow into the dome. This was accompanied by worsening of her cranial neuropathy, necessitating additional fd treatment. The present case provides additional evidence that post-treatment residual flow into an aneurysm can be observed not only immediately following fd placement but also after a period of days to months.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer Contact
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key8085521
MDR Text Key129300920
Report Number2029214-2018-00956
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-475-25
Device Catalogue NumberPED-475-25
Device Lot NumberNOT-REP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2018
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

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