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U.S. Department of Health and Human Services

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

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MEDTRONIC COVIDIEN PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-35
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2016
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex delivery system was returned for evaluation without the microcatheter or pipeline device. As received, the pushwire was found to be separated at the distal hypotube. The distal segment of the pushwire was separated and not returned. The distal hypotube was also found to be stretched with the ptfe shrink tubing still intact. The pushwire was observed to be bent. No other anomalies were observed. The broken end was sent out for scanning electron microscope (sem) analysis. Based on the sem analysis, it appears the pushwire separation was secondary to tensile overload. We are unable to definitively determine the cause of the tensile overload; however the pushwire separation; pushwire (bending) and hypotube (stretching); suggest that excessive forced was used; subsequently causing the pushwire to become separated. Per our instructions for use (ifu): ¿discontinue delivery of the device if high force or excessive friction is encountered 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 micro catheter, or the vessel. ¿ in addition, review of this device lot history record was conducted and no issues were identified that could have contributed to this event. All products are 100% inspected for damage and irregularities during manufacture.
 
Event Description
Medtronic received information that during treatment of an aneurysm located in the supraclinoid segment of the left internal carotid artery, the device was advanced through a curve of the artery and became stuck at the distal segment of microcatheter. The physician then attempted to remove the device with the microcatheter, however part of the hub which was outside the patient was stuck/jammed and didn't allow him to remove the device. It was reported that the only way to retrieve the device was by pushing forward and the device released outside of the patient. The patient was treated by carotid artery occlusion. No patient injury was reported. Through device analysis the push wire of the device was found separated at the distal hypo-tube.
 
Manufacturer Narrative
Information received from the same report as mfr: 2029214-2016-00129.
 
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Brand NamePIPELINE FLEX
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 Key5723715
MDR Text Key47354386
Report Number2029214-2016-00395
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
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 05/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/04/2018
Device Model NumberPED-475-35
Device Lot NumberA037029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2015
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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