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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-71450-25
Device Problems Flaked (1246); Delamination (2904)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/02/2015
Event Type  Malfunction  
Event Description

Medtronic (covidien) received information regarding an incident with one of its products. Treatment of an unruptured saccular aneurysm located in the petrous segment of the left ica (internal carotid artery). During the procedure, it was reported the physician noticed lining (bluish material) from the pushwire peeling off into the rotating hemostatic valve (rhv) of a pipeline (4. 5mm x 25mm) device. The pipeline was successfully implanted inside the patient. During the same procedure, another pipeline (5mm x 35mm) could not be opened on the proximal segment and it was removed from the patient with a gooseneck snare. Post procedural angiogram demonstrated complete occlusion of the aneurysm. (b)(4).

 
Manufacturer Narrative

The device has been received and the evaluation is in progress. A follow-up report will be submitted once the evaluation is complete. The lot history record review of the reported lot number showed no discrepancies that might have contributed to the reported experience. (b)(4).

 
Manufacturer Narrative

The lot history record of the reported lot number has been reviewed. The pipeline delivery system (pushwire) was returned for evaluation without the rhv valve, torque device and catheter. Per the initial report, the pipeline was implanted in the patient. The capture coil appeared to be damaged. No bends were observed on the returned pushwire. The coating of the entire pushwire length was examined under the video inspection system (30x magnification) for coating integrity. The ptfe coating on the pushwire was found scraped at 3 locations. The ptfe coating was also found on the capture coil. No other complaints have been reported against the lot number. Based on the above findings, the customer's report was confirmed. The coating appeared to be damaged by mechanical scraping and abrasion or force. The capture coil was also damaged. However, the cause for damage could not be determined. All products are 100% inspected for damage and irregularities during manufacture.

 
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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
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key4581396
MDR Text Key5453455
Report Number2029214-2015-00235
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/06/2017
Device MODEL NumberFA-71450-25
Device LOT Number9911779
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/23/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/25/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/07/2014
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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