[175913296]
It was reported that stroke occurred. The subject was on a prior regimen aspirin and antiplatelet medication other than aspirin at the time of index procedure. Prior to the index procedure, heparin or other anticoagulant was given. The subject received a loading doses of 81 mg of aspirin and 300 mg of clopidogrel. A sentinel cerebral protection system was placed. A lotus introducer was inserted and then the native aortic valve was treated balloon valvuloplasty. A 27 mm lotus edge valve was advanced. When the deployment of the 27 mm lotus edge valve began; the deployment was not coaxial. The subject was suddenly hypotensive and cpr was initiated. The valve was withdrawn, subject resuscitated and intubated. Once the subject was stabilized the transaortic valve implant (tavi) procedure was continued. Then the aortic valve was treated with and subsequent deployment of the 27 mm lotus edge valve. Successful positioning of the lotus edge valve involved partial re-sheathing of the lotus edge valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus. It was also noted that the subject had asystole for 5-10 min with return of spontaneous circulation during procedure. On the same day of the index procedure, the subject developed cardiac arrhythmia. Electrocardiogram (ecg) revealed first degree arteriovenous (av) block and left bundle branch block (lbbb). A non-bsc permanent pacemaker was successfully implanted on the same day. Medication was given to the subject to treat the hypotension. At the time of reporting, the hypotension was considered to have not resolved. One (1) day post index procedure, the subject was off sedation since 8 am. Stroke alert was called at 5pm as he was not moving the left side to noxious stimuli. Computed tomography angiography was recommended and it revealed acute to subacute infarct involving the left temporo-occipital lobe infarct with localized mass effect and effacement of the temporal horn of the left lateral ventricle. No findings to suggest the hemorrhagic transformation, small hypodensity within the right frontal corona radiata which is unchanged from prior related to an age indeterminate infarct. At the time of reporting, the event subacute infarct was considered recovering/ resolving.
Patient Sequence No: 1, Text Type: D, B5