ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT; HEART VALVE, MECHANICAL
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Model Number ONXAAP-25 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stroke/CVA (1770)
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Event Date 05/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.
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Event Description
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According to initial notification "patient is in the post-market clinical follow-up study protocol of the on-x ascending aortic prosthesis (aap) retrospective study and was implanted on (b)(6) 2014 with a prefabricated aap device sn (b)(6).On (b)(6) 2018 (1,324 days post implant) and presented to the ed from work where he experienced difficulty forming words, slurred speech, right sided headache and left facial droop.All symptoms had resolved quicky prior to arriving to the ed, except light headiness and dizziness.He was admitted for observation and further testing.An mri was performed showing acute infarct involving the insular cortex extending to involve the superior longitudinal fascicular on the right.The ct and cta of the head were unremarkable, the carotid doppler was unremarkable.Inr was 2.0 on admission.Pt was evaluated by pt/ot/st and discharged home on (b)(6) 2018 after adding asa to his daily medication to follow up with cardiologist and neurologist." this complaint is associated with onxaap-25 sn (b)(6).
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Manufacturer Narrative
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Per the adjudication received, this event is not valve related.Per medical device reporting for manufacturers- fda guidance for industry and food and drug administration staff, section 2.16 an mdr report is not required when "you have information that would enable a person who is qualified to make a medical judgement to reasonable conclude that your device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury, if it were to recur." therefore, further investigation is not warranted.Per adjudication received, this event is not valve related; therefore, further investigation is not necessary.
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