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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-450-20
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2015
Event Type  Injury  
Manufacturer Narrative
The pipeline flex has not been returned for evaluation as it remains in the patient. Product analysis cannot be performed. The device was not returned, therefore the reported event could not be confirmed. The cause of the event could not be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report of difficult pipeline flex placement during a procedure. The patient was undergoing flow diversion treatment of an unruptured aneurysm in the right, cavernous (c3) internal carotid artery. The aneurysm max. Diameter was 11. 6mm and neck width was 7. 9mm. It is not known whether the devices were prepared as indicated in the ifu. It was reported that during the procedure, the physician was unable to place the pipeline flex in the desired location due to the patient¿s vasculature. An additional flow diverter was placed to complete the procedure, which was not initially planned. There were no reports of patient injury in association with this event.
 
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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 Key7079089
MDR Text Key93600216
Report Number2029214-2017-01324
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 12/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/23/2018
Device Model NumberPED-450-20
Device Lot NumberA095704
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 Received11/13/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/24/2015
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: 12/04/2017 Patient Sequence Number: 1
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