Model Number FA-71425-35 |
Device Problem
Positioning Failure (1158)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/31/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was not returned for evaluation.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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information that during treatment of an aneurysm located in the internal carotid artery (ica), the physician prepared to release the device, but it was found the "head" of the device could not be opened.It was reported that the physician made numerous maneuvers without success.A new pipeline device was used to complete the surgery.No patient injury was reported.The diameter of the aneurysm was 12 mm x 19 mm.The distal landing zone was 3.69 mm and the proximal was 4.21 mm.
|
|
Manufacturer Narrative
|
The pipeline pushwire was returned without the pipeline braid.The pushwire was observed bent.No other anomalies were observed.Based on the analysis findings and the reported event details the clinical observation could not be confirmed.We are unable to definitively determine the cause for the reported experience.Pipeline braid was not returned for evaluation, therefor any contributing factors from the pipeline braid could not be assessed.In addition, the patient¿s vessel tortuosity was not reported; therefore an y contributing factors from the patient¿s vessel tortuosity could not be assessed.Furthermore, the cause for the push wire bent damage could not be determined.All products are 100% inspected for damage and irregularities during manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|