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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-475-16
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device has been received for evaluation. Once completed a supplemental report will be submitted.
 
Event Description
Medtronic received information that the dstal of the pipeline would not deploy or open. The device was removed from the patient. No injury reported. The procedure was completed with a different size pipeline. The pipeline was prepared as indicated in the ifu. Continuous heparinized saline flush was used as per the ifu during the procedure. There were no other steps or devices required to open the pipeline and there were no patient symptoms associated with the event. Angiographic results post procedure were good.
 
Manufacturer Narrative
The pipeline braid was returned for evaluation without the pipeline flex pushwire. The reason the pipeline flex pushwire was not returned for evaluation was not provided. The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified. The pipeline braid was observed to be fully open with both ends having slight fraying. Dried blood was found throughout the pipeline braid. No other anomalies were observed. The product analysis does not suggest a potential or confirmed manufacturing issue; therefore, no lot history record review is required. This device was used to treat an aneurysm. However, the treatment site for this device is unknown as the treatment site was not reported. Additionally, the patient anatomy condition was not reported; therefore any contributing factors from the patient anatomy could not be assessed. Based on the analysis findings and the reported event details, the customer¿s report was not confirmed. The cause for the reported e xperience could not be determined as the returned pipeline braid was observed to be fully open with damage on both ends (fraying). It is possible the damaged braid may have contributed to the reported issue. However, the causer for the damage could not be determined. No evidence was found to suggest that the device failed to meet specifications; therefore manufacturing has been ruled out as a potential cause. All products are 100% inspected for damage and irregularities during manufacture. Per our instructions for use (ifu): the user should "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. Resheathing 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. ¿.
 
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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
medtronic nv
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key6251282
MDR Text Key107510873
Report Number2029214-2017-00045
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/16/2018
Device Model NumberPED-475-16
Device Lot NumberA148301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2015
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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