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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 Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paresis (1998); Thrombus (2101)
Event Date 05/05/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned as it was implanted in the patient. Attempts have been made to obtain additional information, however, our attempts were unsuccessful. Based on this information, there is no reasonably suggestion that a malfunction or quality deficiency of the device occurred during the treatment procedure or post the procedure. In-stent thrombosis and hemiparesis are known inherent risks of endovascular procedures and are documented in our devices' instructions for use (ifu). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that 9 months post the uneventful pipeline procedure the experienced right sided hemiparesis, as the stent was alleged to have thrombosed. The patient seems to be okay when back on plavix but experiences recurrence of symptoms when dapt was discontinued.
 
Manufacturer Narrative
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
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7756259
MDR Text Key116211743
Report Number2029214-2018-00697
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
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 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

Patient Treatment Data
Date Received: 08/07/2018 Patient Sequence Number: 1
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