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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Lot Number NOT AVAILABLE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 05/04/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device will not return for analysis as it remains in the patient. Based on the reported information there was no device issue during the original procedure as this event was observed 3 years post procedure. Mdrs from this event: 2029214-2017-00719 2029214-2017-00720.
 
Event Description
Medtronic received information that 3 years after receiving the pipeline device to treat a 10mm ophthalmic aneurysm of the left ica, the aneurysm was not completely closed and required retreatment. The patient was re-treated with another pipeline flex device.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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
9498373700
MDR Report Key6602671
MDR Text Key106973892
Report Number2029214-2017-00720
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
Report Date 05/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberNOT AVAILABLE
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 Received05/04/2017
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: 05/31/2017 Patient Sequence Number: 1
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