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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage, Cerebral (1889)
Event Date 03/29/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The 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 was unknown. The location of the hemorrhage is distal to the aneurysm and also distal to the location of pipeline implant. Additionally, the patient's response to dual antiplatelet treatment (pru level) was not available. Intracerebral bleeding is a known risk of flow diversion procedure and is documented in the pipeline flex instruction for use.
 
Event Description
Medtronic received information that a patient suffered an occipital intracerebral hemorrhage 15 days post treatment of an aneurysm located in the left paraclinoid segment of the internal carotid artery. The hemorrhage was observed on the same side as the aneurysm when computed tomography (ct) image was taken. The physician suspected the cause of the hemorrhage was hyper perfusion. Decompression treatment was performed the same day. It was further reported that a second hemorrhage was seen one day post decompression treatment on the opposite side of the aneurysm; however, the exact location of the second hemorrhage was not provided. Patient has not recovered; and is currently in icu and may have hemiplegia. The patient is staying at icu and condition is being monitored. The patient was on dapt post treatment.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key5607799
MDR Text Key106360429
Report Number2029214-2016-00252
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,Followup
Report Date 03/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/23/2018
Device Model NumberPED-400-20
Device Lot NumberA078525
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 Received03/30/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/24/2015
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: 04/26/2016 Patient Sequence Number: 1
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