Model Number PED-250-18 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Occlusion (1984); No Code Available (3191)
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Event Date 05/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned as it was implanted in the patient.Attempts have been made to obtain additional information.However, our attempts have been unsuccessful.Thrombus formation and dissections/ injuries are known inherent risk of the endovascular procedures and is documented in our devices¿ instructions for use (ifu).Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the devices occurred during the treatment procedure.There is no evidence suggesting that the devices were defective, but rather a procedure and patient condition related event and the exact cause is unknown.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received the following report through a health care professional conference.One case that was presented stated that 18 months after the uneventful the pipeline embolization procedure, the pipeline was alleged to have been occluded.This event was treated with 9f cello and 3 max (aspiration only).A dissection was alleged to have occurred because of the cello being in the carotid, wh ich was subsequently stented.The aneurysm was in the left pcom, which recurred after 6 months post initial coil treatment.Prior to the procedure, the patient was on asa only for 10 days with no issues.
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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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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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