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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX 4.50MM X 20MM INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE FLEX 4.50MM X 20MM INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-20
Device Problems Physical Resistance (2578); Difficult to Advance (2920); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been returned for evaluation; however, return is anticipated. Without return of the device, no definitive conclusions can be drawn regarding the clinical observation. Should the device be returned or additional information become available, a supplemental report will be submitted.
 
Event Description
Medtronic received information that the pipeline flex did not open proximally during treatment of an aneurysm located in the left ophthalmic artery. It was reported that friction was encountered in the distal segment of the marksman during delivery of the device, as the patient had severe tortuosity. The device was attempted to be delivered by using a combination of pushing the delivery wire and unsheathing. The device was resheathed two times after half of the device was deployed; however the proximal end would not open. The device was then resheathed and removed from the patient. The patient was treated with another device. No patient complications were reported.
 
Manufacturer Narrative
The device was returned. The customer¿s clinical observation could not be confirmed as the device was found fully opened. Damaged braid was observed at both ends. However the cause for damaged braid could not be determined. All products are 100% inspected for damage and irregularities during manufacture.
 
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Brand NamePIPELINE FLEX 4.50MM X 20MM
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 Key5352524
MDR Text Key35676014
Report Number2029214-2016-00012
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCI
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 02/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/19/2018
Device Model NumberPED-450-20
Device Lot NumberA092780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2015
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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