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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Thromboembolism (2654)
Event Type  Injury  
Manufacturer Narrative
The device was not retuned for analysis as it was implanted in the patient. Attempts have been made to obtain additional information, however, our attempts have been unsuccessful. The flow diverter was reported to have performed as intended by successful deployed and implantation within the intended treating location. Therefore, there is no allegation that the device was defective or that a malfunction occurred during its use. This event appears to be more patient condition and procedure related. However, its exact cause is unknown. Thromboembolism is a known inherent risk of endovascular procedure and is documented in our device's instruction for use. Linked mdrs events: 2029214-2017-00880 and 2029214-2017-00882.
 
Event Description
Citation: ¿antiplatelet drug resistance did not increase the thromboembolic events after stent-assisted coiling of unruptured intracranial aneurysm: a single center experience of 99 cases¿. Jihye song, yong sam shin. Neurol sci (2017) 38:879¿885 doi 10. 1007/s10072-017-2859-z. Medtronic received the following reports: (b)(6) female patient was treated with two flow diverter devices (4. 25-25 and 4. 25-20), for a left internal carotid artery (ica) cavernous aneurysm. The patient was reported to have a delayed thromboembolic event. The patient had no symptoms and was on aspirin. Imaging finding revealed left frontal and basal ganglia infarct. This event was conservatively managed. At one month follow up, the mrs was 0.
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key6701871
MDR Text Key79646650
Report Number2029214-2017-00881
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeKS
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 06/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/14/2017
Was Device Evaluated by Manufacturer? No
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: 07/11/2017 Patient Sequence Number: 1
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