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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-500-25
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2018
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation. However, the device is pending return. Upon receipt of the device a supplemental report will be filed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during embolization treatment of carotid artery, while pipeline flex device was advanced in the medtronic catheter the pipeline pushwire broke. It was reported that the physician felt strong resistance while delivering the pipeline through microcatheter after flushing as according to the ifu. However, the physician somehow kept delivering, deployed the flow diverter and started resheathing, but resheathing was not very smooth. The flow diverter was deployed and opened at the desired position. However, while advancing the microcatheter in order to retrieve the pipeline delivery pushwire, the catheter got caught on the delivery pusher (probably the sleeve of the system). The physician kept retrieving the pusher into the catheter but still the pushwire caught on the catheter. The physician successfully retrieved the pushwire into the catheter by pushing the pusher little bit. However, upon completing retrieving, snapping noise was heard. Nothing was left inside the patient¿s body. The vessel was slightly severe and slightly large in diameter. There were no reports of patient injury in association with this event.
 
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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
9498373700
MDR Report Key8150716
MDR Text Key129912914
Report Number2029214-2018-01048
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 03/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/09/2021
Device Model NumberPED-500-25
Device Lot NumberA643198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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