Model Number PED-475-14 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Infarction, Cerebral (1771); Paresis (1998)
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Event Date 02/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there is no evidence suggesting that the device was defective.The cause of the ischemic stroke and left superior quadrantanopia can not be reliable determined.However, ischemic events and neurological deficits are known inherent risks of the endovascular procedure and are listed in the pipeline flex instruction for use.
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Event Description
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Medtronic received information that a patient experienced a mild ischemic stroke approximately five months post pipeline treatment.It was reported that this patient came in with new left arm and face weakness (left superior quadrantanopia).There was no additional treatment given for the stroke.It was noted that this patient was resistant to plavix and was put on berlinta.After taking it for 4 months the patient stopped taking it early.Three days after coming off the patient suffered a mild stroke, but is doing okay per the physician.The stroke was noted to be within the right middle cerebral artery (mca) inferior division.The symptoms are improving and the patient was discharged with mrs 1.The patient was treated for an aneurysm located in the right middle cerebral artery (mca).Dapt was administered.Pru levels are unknown.
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Manufacturer Narrative
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As per the ifu: the pipeline flex embolization device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments.
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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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