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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
Model Number PED-450-16
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problems Infarction, Cerebral (1771); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Occlusion (1984); Rupture (2208); Stenosis (2263); No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned as it was implanted in the patient. Follow up attempts to gather additional information have been made. However, we have been unsuccessful. Since the device was not returned, we are unable to perform further root cause analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received the following report, the patient had a left internal carotid artery (ica) ophthalmic aneurysm. The aneurysm was reported to have doubled in size over time. A ped 4. 5x16 was used for treatment. The ped was twisted and there was severe stenosis in the vessel. A hyperform 7x7 balloon was used to open it but was difficult to cross the stenosis proximally. Access was then tried via the acom which lead to vessel rupture and extravasation (increased intracranial pressure (icp) and blood pressure (bp)). A balloon was used to arrest the bleeding. No ventriculostomy was performed despite the hemorrhage. The patient at follow-up had evidence of multiple strokes.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Received information that this event is the same event that was initially submitted under mdr # 2029214-2017-01128. If information is provided in the future, a supplemental report will be issued.
 
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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 Key7719842
MDR Text Key115372582
Report Number2029214-2018-00652
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-16
Device Catalogue NumberPED-450-16
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 Received08/08/2018
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

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