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Model Number PED-450-25
Device Problems Break (1069); Difficult to Open or Close (2921); Activation Failure (3270)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2018
Event Type  malfunction  
Manufacturer Narrative
The pipeline will not be returned as it remains in the patient; however the pushwire is expected to be returned. Upon receipt of the device, a supplemental report will be filed. If information is provided in the future, a supplemental report will be issued.
Event Description
Medtronic received information that during embolization treatment, this pipeline flex embolization device failure to open at the proximal end and pushwire broke. It was reported that this was a ruptured aneurysm that the physician was pipelining and coiling of amorphous internal carotid artery, measuring 8 mm x 4 mm, landing zone distal 4. 00 mm proximal 4. 35 mm. Vessel tortuosity was described as normal. It was reported that the pipeline was opened distally and was opening well. When the physician was opening the last 5 mm of the pipeline by pushing wire the pipeline delivery wire broke by the resheathing pad. The pipeline delivery system was then pulled out of the patient. The distal wire and resheathing pad are still in the patient and the proximal segment of the pipeline did not open. The physician tried multiple times to bump the proximal segment of the pipeline with the microcatheter and guide catheter, but it would not open. Tried to snare the pipeline but was not successful and left the pipeline inside the patient. The patient leaves on antiplatelet therapy. There were no reports of patient injury in association with this event.
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
The pipeline flex was returned for evaluation and the clinical observation was confirmed regarding pushwire broke but did not confirm regarding ¿failure to open¿ issue. The proximal segment of the pushwire appeared to be detached at the hypotube proximal to the wire weld. The distal detached segment of the pushwire along with the pipeline flex braid was not be returned as they were remained inside the patient. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. Kinks and bends were found on the pushwire from the proximal end. The detached distal end of the hypotube was then sent out for scanning electron microscope (sem) and energy dispersive x-ray spectroscopy (eds) analyses and the results showed presence of soldering material (tin); thereby indicating that the soldering was conducted. The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection. Based on the investigation and results received fro m outside services, the damages seen on the returned proximal wire (kinking/bending) and hypotube (stretching) appears to have been due to excessive forced used (pushing and pulling). The distal wire possibly detached due to tensile failure; however, the event cause could not be determined. Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures. Per the instruction for use (ifu): ¿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. The pipeline flex embolization device is fully resheathed when the distal marker is retracted completely inside the micro catheter. The system is designed to allow for 2 full cycles of resheathing of the pipeline flex embolization device. Resheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. 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. ¿ if information is provided in the future, a supplemental report will be issued.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
gabriela mclellan
9775 toledo way
irvine, CA 92618
MDR Report Key7741086
MDR Text Key116052404
Report Number2029214-2018-00692
Device Sequence Number0
Product Code OUT
Reporter Country CodeUS
PMA/PMN Number
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 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model NumberPED-450-25
Device Lot NumberA468652
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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: 08/01/2018 Patient Sequence Number: 1