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Model Number FA-71475-35
Device Problems Positioning Failure (1158); Flaked (1246)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
The device has not been returned for evaluation; however, return is anticipated. 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.
Event Description
Medtronic received information that during treatment of an aneurysm located in the ophthalmic segment of the left internal carotid artery (ica), the distal segment of the device did not open as it was stuck in the capture coil. It was reported that the physician used marksman to transfer the pipeline in place, but it was found that the distal segment could not be opened, despite several attempts. The physician rotated the push wire up to 10 times. The physician was worried that it could not be removed. However was able to remove the system from patient. It was further reported that the marksman was accordion, after long time operation not much resistance was encountered. Two new devices were used with new marksman to complete the procedure successfully. The patient's current status is normal. The aneurysm was unruptured and saccular. The aneurysm neck size was 32 mm and the max diameter was 22 mm. The proximal landing zone was 4. 8 mm and the distal landing zone was 4. 25 mm. The patient hand moderate vessel tortuosity. The tip of the sheath was seated deeply in the hub of the microcatheter. Continuous heparinized saline flush was also used, as per ifu, during the procedure.
Manufacturer Narrative
The pipeline pushwire and braid, and microcatheter were returned for evaluation. The pipeline pushwire was observed to be within the marksman with an rhv attached to the microcatheter hub and a torque device attached to the proximal section of the pipeline pushwire. The torque device and rhv were removed from the marksman and pipeline pushwire with no issues. For further examination, the pipeline pushwire was pushed through the microcatheter with no issues. 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 one end having slight fraying. Based on the analysis findings the clinical observation could not be confirmed. The cause for the reported experience could not be determined as the returned pipeline braid was observed to be released from the capture coil with damage. We are unable to definitively determine the cause for the damage. All devices are 100% inspected for damage and irregularities during the manufacturing process. Ancillary findings not related this event observed during analysis include coating damage caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve near the distal end of the pushwire.
Manufacturer Narrative
Correction: ancillary findings identified coating damage at the distal end of the pushwire to be coating delamination. A formal investigation has been initiated and is currently underway. (b)(4).
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key5702228
MDR Text Key108312279
Report Number2029214-2016-00369
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/23/2019
Device Model NumberFA-71475-35
Device Lot NumberA232637
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction Number2029214-10/7/16-001-R