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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-25
Device Problems Material Twisted/Bent (2981); Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 07/12/2018
Event Type  malfunction  
Manufacturer Narrative
The device has been received, however, the device analysis has yet not began. A supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that during delivery of the pipeline it twisted. A triaxial system to achieve utmost support was not used when introducing the pipeline. The distal end opened perfectly but as we left a straight segment for a curve proximally, the pipeline would twist. After a couple resheathing and wagging opportunities, the physician thought it was best to remove system. A new device was used to treat the patient. The aneurysm was in the right internal carotid artery (ica) pcom. It was unruptured, fusiform, with a max diameter of 5mm and neck of 5mm. The distal landing zone was 10mm and proximal was 5mm. The anatomy was moderate in tortuosity.
 
Manufacturer Narrative
The pipeline flex braid was returned for evaluation without the pushwire as it was likely discarded. The pipeline flex braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified. Both ends of the pipeline flex braid were found fully opened with no damage. No other anomalies were observed. Based on the analysis findings, the report of failure to open could not be confirmed and the event cause could not be determined, as the returned pipeline flex braid was found fully opened with no damage. It's possible that the "moderate vessel tortuosity" may have contributed to the reported issue. Per our instructions for use: "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously. After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device. Re-sheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device. Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked. If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it. Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. ¿ all products are 100% inspected for damage and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

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Brand NamePIPELINE FLEX
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
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7757851
MDR Text Key116860888
Report Number2029214-2018-00699
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,Followup
Report Date 10/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/26/2020
Device Model NumberPED-500-25
Device Lot NumberA482850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/07/2018 Patient Sequence Number: 1
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