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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN, IRVINE PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-20
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information, device evaluation the reported pipeline flex embolization device with shield technology (ped2) was received and evaluated. The ped2 delivery wire was found to be bent at 26. 5 cm from the proximal end, and the distal hypotube appeared stretched. The ped2 braid was found to have damages, fraying, to both ends the distal end of the ped2 braid was found not opened due to damages to braid. No other anomalies were observed on the returned device. Based on the product analysis, the report of ped2 braid did not open at the distal segment was confirmed. The observe damages on the ped2 most likely occurred when high force or excessive friction encountered during delivery of the ped2. The patient's anatomy could have contributed to friction and need for high force. The ped2 instruction for use states" caution: if high forces or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and micro catheter simultaneously. Advancement of the pipeline flex embolization device against resistance may result in damage or patient injury. " all devices are 100% inspected for damage and irregularities during manufacture. No evidence was found to suggest that the devices failed to meet specifications; therefore, manufacturing has been ruled out as a potential cause. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device is in route to medtronic, but has not yet been received. Without return of the device, no definitive conclusions can be drawn regarding the clinical observation. Should the device be returned or additional information become available, a supplemental report will be submitted. Note: suspect medical device - similar device brand name
=
pipeline flex w/shield technology model #
=
ped2-500-20.
 
Event Description
Medtronic received information that the pipeline shield device failed to open at the distal segment during a flow diversion procedure. It was reported the pipeline shield device was used to treat the patient's cerebral aneurysm located at left internal carotid artery cavernous segment. The aneurysm has maximum diameter of 11. 35mm and neck diameter of 6. 31mm. The landing zone artery sizes were 3. 87 distally and 4. 92 proximally. The patient's vessel tortuosity was described as minimal. It was reported the device was prepared according to the ifu. During delivery of the pipeline shield, resistance was met in microcatheter. The pipeline shield was resheath more than 2 times. About 1/3 of the pipeline shield was unsheathed with resistance, and the distal segment of the pipeline shield failed to open. The pipeline shield was withdrawn from the patient together with the microcatheter. New devices were implanted for the patient to complete the treatment. No injury reported.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key6956572
MDR Text Key271273900
Report Number2029214-2017-01161
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
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
Report Date 03/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/22/2020
Device Model NumberPED-500-20
Device Lot NumberA419283
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2017
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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