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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-425-20
Device Problems Difficult To Position (1467); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex will not be returned for evaluation as it was discarded by the customer. The device was not returned, therefore the event could not be confirmed. An event cause could not be conclusively determined from the reported information. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that a pipeline flex did not open during a procedure. The patient was undergoing treatment for an unruptured, saccular aneurysm in the paraophthalmic internal carotid artery (ica). The a neurysm maximum diameter was 20 mm and the neck diameter was 9 mm. The distal landing zone was 3. 5 mm and the proximal was 4. 20 mm. The patient had normal vessel tortuosity. The pipeline flex and accessory devices were prepared as indicated in the ifu. It was reported that the physician attempted to land the distal end of the pipeline flex braid just proximal to the a1; there was only 5mm between the distal edge of the aneurysm and the a1. The distal edge of the pipeline flex was slow to open. As a result, the pipeline flex and microcatheter "flopped" into the aneurysm missing the landing zone. The pipeline flex was removed and a new device was used to complete the procedure. Angiographic result post procedure showed stasis. There were no reports of patient injury in connection with 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 Key6026575
MDR Text Key107866483
Report Number2029214-2016-00896
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/20/2018
Device Model NumberPED-425-20
Device Lot NumberA176432
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/21/2015
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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