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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
Model Number PED-500-35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Brain Injury (2219)
Event Date 07/04/2016
Event Type  Death  
Manufacturer Narrative
The pipeline flex device will not be returned for evaluation as it was implanted in the patient. Based on the reported information, there did not appear to have been any defect of the device during use. The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information. Mdrs related to this event: 2029214-2016-00757 2029214-2016-00758 2029214-2016-00759. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that a patient experienced infarction after pipeline flex implantation. The patient was undergoing treatment for an unruptured, fusiform aneurysm in the basilar artery. The max. Diameter was 2. 5cm and neck diameter was 2cm. Vessel tortuosity was normal. All devices were prepared as indicated in the ifu. Dual antiplatelet treatment was administered; blood tests indicated that the patient is responsive to aspirin and clopidogrel. Three pipeline flex devices were implanted in a telescoping manner from 5mm below the basilar tip to the junction of the vertebral arteries. The aneurysm was then filled with non-medtronic coils. There were no issues noted during the procedure. Two hours after the procedure, the patient experienced bilateral infarction of the cerebellum. The physician reports that the infarction was not caused by the pipeline devices, but is a risk of the treatment. The patient was admitted to intensive care and later passed away.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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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
9496801224
MDR Report Key5912182
MDR Text Key53435672
Report Number2029214-2016-00758
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/23/2017
Device Model NumberPED-500-35
Device Lot NumberA022223
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 Received08/01/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/24/2014
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: 08/29/2016 Patient Sequence Number: 1
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