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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-375-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Perforation (2001)
Event Date 11/14/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Description in initial report: it was reported this patient had severe vessel tortuosity. It took "6 turns" to reach the target lesion. Corrected information: it was reported this patient had 6 severe vessel bends. The pipeline flex device did not reach the targeted lesion.
 
Manufacturer Narrative
The reported device was discarded by the facility. Therefore, a product evaluation cannot be performed and the clinical experience cannot be conclusively determine. However, the patient's tortuosity vessel anatomy could be a contributing factor. Additional information has been requested. Should any new information be received. A supplement report will be filed. Linked mdr's 2029214-2017-01339, 2029214-2017-01340, 2029214-2017-01342. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that 2 pipeline flex devices were stuck inside marksman catheters during delivery at a flow diversion procedure to treat a patient's cerebral aneurysm. The first set of pipeline flex and marksman catheter was used and removed from the patient after the physician could not deploy the pipeline. The second set of pipeline flex and marksman catheter was used to continue the flow diversion procedure. The microcatheter was placed distally to the aneurysm. During the delivery of the pipeline, friction was encountered. It was reported "the carotid artery was torn because of friction. ". The patient had a 2 cm tear at the vessel with carotid cavernous fistula. Coil implants were used for treatment. The scheduled aneurysm treatment was ceased. It was reported this patient had severe vessel tortuosity. It took "6 turns" to reach the target lesion.
 
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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
9496801224
MDR Report Key7107262
MDR Text Key107096517
Report Number2029214-2017-01341
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 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/17/2019
Device Model NumberPED-375-20
Device Lot NumberA262802
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 Received12/14/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/17/2016
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: 12/11/2017 Patient Sequence Number: 1
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