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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-18
Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/30/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The pipeline flex delivery system and catheter were returned for evaluation without the pipeline flex braid. As received, the pipeline flex push wire was found outside of the catheter. The tip coil appeared to be damaged. The pipeline flex delivery system was returned without the braid; any contributing factors from the braid could not be assessed. Based on the analysis findings and the reported event details, the report of pipeline flex failure to open could not be confirmed. The tip coil was found to be damaged. However, the cause for damages could not be determined. All products are 100% inspected for damage and irregularities during manufacture.

 
Event Description

Medtronic received report that a pipeline flex did not open during a procedure. The patient was being treated for an unruptured, saccular aneurysm in the periophthalmic internal carotid artery (ica). The aneurysm measured 5mm max diameter and 2mm neck width. Landing zone artery size was 4. 24mm distal and 4. 5mm proximal. Vessel tortuosity was normal. The devices were prepared and used as per ifu. The guide catheter and catheter were positioned and delivery of the pipeline flex began. During delivery, the pipeline flex was reportedly slow to open on the distal end. Deployment was continued and it was reported that the middle section of the pipeline flex was twisted. The pipeline flex was resheathed. Deployment was attempted again and the pipeline flex still appeared flattened and twisted. The physician removed the device by resheathing and pulling it back through the catheter. The procedure was continued using a new pipeline device, which deployed successfully. Post-procedure angiographic result was good. There was no report of patient injury as a result of this event.

 
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Brand NamePIPELINE FLEX 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
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key5394559
MDR Text Key37619242
Report Number2029214-2016-00048
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/11/2018
Device MODEL NumberPED-450-18
Device LOT NumberA072497
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/12/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2015
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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