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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-500-35
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/08/2016
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 reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information.
 
Event Description
Medtronic received report of pipeline flex did not open during a procedure. The patient was undergoing treatment for an unruptured aneurysm located in the right cavernous internal carotid artery (ica). The aneurysm measured 25mm and the vessel diameter was approximately 5mm. The vessel tortuosity was slightly severe. The devices were prepared as indicated in the ifu. It was reported that a pipeline flex was deployed and did not open. The physician attempted to "spread and resheath" the device a few times, but the pipeline flex and catheter became stuck near the aneurysm neck. The physician suspected that the devices were damaged and removed them from the guide catheter. Afterward, a new pipeline flex was able to be implanted in the desired location. There were no reports of patient injury in connection with this event. The patient is currently fine.
 
Manufacturer Narrative
The pipeline flex pushwire was returned for evaluation with the catheter. As received, approximately 14. 5 cm of the distal segment of the pipeline flex pushwire was deployed outside of the catheter tip. The remainder of the pushwire was found stuck inside the distal segment of the catheter. The pipeline flex braid was not returned. For further examination, the pipeline flex pushwire was pushed out of the catheter lumen with difficulty. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. Kinks and bends were found on the pushwire approximately 37 to 42. 5 cm from the proximal end. Based on the analysis findings and event description, the report of pipeline flex failure to open could not be confirmed as the braid was not returned for evaluation. It¿s possible that the patient's vessel tortuosity may have contributed to the reported issue. The report of resheathing resistance was confirmed as the received pipeline flex pushwire was found stuck inside the distal segment of the catheter. However, the cause for resistance could not be determined. Additionally, the damage observed on the proximal wire (bending) and hypotube (stretching) suggest that excessive force used. All products are 100% inspected for damage and irregularities during manufacture. Per our instructions for use (ifu), the user should ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel. 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. ¿.
 
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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 Key5998016
MDR Text Key107885604
Report Number2029214-2016-00865
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 09/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/16/2019
Device Model NumberPED-500-35
Device Lot NumberA295473
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2016
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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