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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Thrombosis (2100)
Event Date 01/04/2016
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis as it was implanted in the patient. Attempts have been made to obtain additional information, however, our attempts have been unsuccessful. Inflammation and thrombosis formation are known inherent risk of endovascular procedure and are documented in the pipeline instruction for use. Based on the reported information, there was no allegation that a malfunction or deficiency of the device occurred during the procedure. There is no evidence suggesting that the device was defective, but rather a post procedure and patient condition related event. However, the exact cause remains unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that post pipeline embolization procedure, the patient developed inflammation due to thrombus not mass effect. It was determined the symptom were not related to the device or the flow diverter treatment. The issue was not critical, and the patient was confirmed to have recovered approximately 5 months post intervention. The cerebral aneurysm was reported to have been 25mm.
 
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Brand NamePIPELINE FLEX
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 Key7073464
MDR Text Key93419667
Report Number2029214-2017-01318
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/07/2018
Device Model NumberPED-425-20
Device Lot NumberA117742
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 Received11/09/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/08/2015
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: 11/30/2017 Patient Sequence Number: 1
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