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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-400-18
Device Problems Break (1069); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device is expected to be returned to medtronic and is currently in transit. A follow-up mdr will be submitted when evaluation of the device is complete. Suspect medical device brand name
=
pipeline flex with shield technology model #
=
ped2-400-18.
 
Event Description
Medtronic received report of pipeline flex with shield push wire separation. The patient was undergoing treatment for an unruptured, amorphous aneurysm in the right internal carotid artery (ica) at the posterior communicating (pcom) segment. The aneurysm max. Diameter was 10mm and neck diameter was 4mm. The landing zone artery size was 4mm distal and 4. 25mm proximal. The vessel was severely tortuous. All devices were prepared as indicated in the ifu. The microcatheter was navigated to the m3 middle cerebral artery (mca). It was reported that a great amount of resistance was experienced when advancing the pipeline flex from the sheath to the microcatheter. The pipeline flex was advanced until the tip coil aligned with the microcatheter marker. The physician began deployment by pulling back on the microcatheter. The distal section of the pipeline flex was well apposed to the vessel wall and the physician began to push the device. After a first check, the pipeline flex appeared to be positioned too distal. The physician began to pull back on the microcatheter, but the pipeline flex moved too proximal. The physician attempted to resheath in order to reposition. Tension was removed from the system. The physician moved from microcatheter from a curve; the delivery wire was pulled and microcatheter was pushed forward, but the system was stuck. The physician was unable to resheath any part of the pipeline flex. The physician applied more force and the push wire separated from the pipeline flex - the pipeline flex remained in position and the wire moved freely. The pipeline flex was only partially opened. The physician advanced the guide wire and removed the system (partially opened pipeline, microcatheter, and delivery wire) from the patient. A new pipeline flex was implanted without issue. There were no reports of patient injury in connection with this event.
 
Manufacturer Narrative
The pipeline flex delivery system was returned for evaluation with the microcatheter and guide catheter. As received, the pipeline flex braid was found to be deployed inside the guide catheter. The distal segment of the pipeline flex delivery system was found to be partially deployed outside of the microcatheter tip; the remainder of the delivery system was found inside the microcatheter lumen. The pipeline flex delivery system was pushed out of the microcatheter lumen. The pipeline flex delivery system was found to be intact. No separation issues were found. Based on the analysis findings and additional event details, this event is no longer mdr reportable.
 
Event Description
Medtronic received corrected event information: the pipeline flex push wire did not separate; the pipeline flex braid was unintentionally released from the push wire.
 
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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 Key5852636
MDR Text Key107903701
Report Number2029214-2016-00666
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
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 07/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/20/2018
Device Model NumberPED-400-18
Device Lot NumberA135922
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2015
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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