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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-71425-25
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2015
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline delivery system and its introducer sheath were returned for evaluation without the torque device (pin vise) or rotating hemostatic valve (rhv). As received, the pipeline was found to be released from the capture coil and partially deployed out of the catheter tip. The remainder of the the pushwire and braid was inside the catheter lumen. For further examination, the pipeline delivery system was pushed out of the catheter lumen. The capture coil was found to be damaged and the pushwire was found to be bent inside of the capture coil. Both ends of the pipeline braid were found fully open with fraying damage on the distal end. The pushwire was found to be bent at one point on its body. Based on the customer¿s photos, the analysis findings and the reported event details, the customer¿s complaints were confirmed. It is possible that the reported resistance may have contributed to the issues; subsequently causing the pipeline delivery system and the catheter to become damaged. However, the cause for the resistance could not be determined. Several attempts to follow-up for the patient anatomy were sent, but no additional information was provided. Therefore, any contributing factors from the anatomy could not be assessed. The coating damage on the pushwire appeared to have been caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve. The torque device and rhv were also not returned for evaluation; therefore any contributing factors from the torque device/rhv valve could not be determined. The lot history record of the reported lot number showed no quality issues against the lot and no other anomalies were found during the document review. In this event, the user context may have contributed to the reported issues as ¿the physician made multiple attempts to deliver the pipeline despite of the excessive resistance¿. Per our instructions for use (ifu), the user should ¿discontinue delivery of the device if high force or excessive friction is encou ntered during delivery. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the microcatheter, or the vessel. ¿.
 
Event Description
Medtronic received report that a pipeline device became locked up in a catheter during a procedure. The patient was being treated for a giant aneurysm. The physician reportedly followed the ifu. It was reported that the catheter and pipeline were placed in the desired position. The physician attempted to unsheath the pipeline device, but could not retract the catheter due to resistance. The pipeline could not be advanced further; it was locked up in the c atheter. After a few unsuccessful deployment attempts, the system (including the pipeline and catheter) was withdrawn. There was no report of patient injury as a result of this event. The procedure was completed using a new device.
 
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Brand NamePIPELINE 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
medtronic miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key5626518
MDR Text Key105968486
Report Number2029214-2016-00272
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
P100018.S004
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 04/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/26/2017
Device Model NumberFA-71425-25
Device Lot NumberA008184
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2014
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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