Model Number FA-77275-20 |
Device Problem
Positioning Failure (1158)
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Patient Problem
Vascular Dissection (3160)
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Event Date 08/31/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation; without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Follow up is being performed.If the device or additional information should be received, a supplemental will be submitted.
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Event Description
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Medtronic received information that during treatment of an aneurysm, after radiography m2 segment of the internal carotid artery (ica) dissection was observed.The origin of the dissection is unknown at this time.It was further reported that the physician found the "head" of the device could not be opened, the physician made adjustments but failed and the pipeline was removed.The surgery was completed using coils.No patient injury was reported.
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Manufacturer Narrative
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The pipeline was returned within the microcatheter.The pipeline braid was observed to be partially deployed approximately 1.0 cm and released from the capture coil.For further examination, the pipeline delivery system was pushed out of the catheter with no issues.The pipeline braid was observed to be fully open with dried blood with the distal end having slight fraying, and the middle section and proximal end having no damages.Pushwire was also observed bent.No damages were found on the tip coil.No other anomalies were observed.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.The patient anatomy condition was not reported; therefore any contributing factors from the patient anatomy could not be assessed.It is possible that the ¿damaged braid¿ may have contributed to the reported issue.In addition, damages seen on the pushwire (bending) and catheter body (flattening / kinking); appears there was excessive force used.However, the cause for the damages could not be determined.Per our instructions for use (ifu): ¿detachment can be facilitated by slowly rotating the delivery wire in the clockwise direction and/or manipulating the microcatheter by locking down the delivery wire and moving both as a system.If the capture coil tip of the delivery system becomes stuck in the mesh of a delivered ped, rotate the wire clockwise while advancing the wire to try to release it, then slowly pull back on the delivery wire.Rotate the delivery wire only in a clockwise direction.Rotating in a counter-clockwise direction may make device release more difficult or impossible.If high force or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.¿ all products are 100% inspected for damage and irregularities during manufacture.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction: no remedial action was initiated due to inspection.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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