SHORTCUT

Description of Event or Problem

A 74-YEAR-OLD MALE WITH A PREVIOUSLY IMPLANTED 21-MM MAGNA VALVE VIA SAVR, WHICH FAILED DUE TO AORTIC STENOSIS (AS). THE PATIENT SUCCESSFULLY UNDERWENT LEFT CORONARY CUSP (LCC) SINGLE-LEAFLET SPLITTING USING THE SHORTCUT DEVICE. SEVERAL HOURS LATER ON THE SAME DAY, THE TD REPRESENTATIVE, WHO WAS PRESENT DURING THE PROCEDURE, RECEIVED AN UPDATE THAT THE PATIENT EXPERIENCED STROKE-LIKE SYMPTOMS (HEMIPARESIS) DURING POST-OPERATIVE RECOVERY FOLLOWING THE SUCCESSFUL LEAFLET SPLIT AND IMPLANTATION OF A SAPIEN VALVE DURING THE TAVR PROCEDURE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING.

Additional Manufacturer Narrative

MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL CLINICAL INFORMATION FROM THE HOSPITAL SITE REGARDING THE REPORTED STROKE-LIKE SYMPTOMS; HOWEVER, THESE EFFORTS WERE UNSUCCESSFUL. THE ONLY INFORMATION RECEIVED WAS THAT THE PATIENT IS RECOVERING FROM THE STROKE AND REMAINS AT A REHABILITATION CENTER. DUE TO THE ABSENCE OF DETAILED PATIENT MEDICAL HISTORY, BASELINE RISK FACTORS, AND INFORMATION REGARDING THE TIMING OF SYMPTOM ONSET, IT IS NOT POSSIBLE TO DETERMINE THE ETIOLOGY OF THE EVENT. AS A RESULT, A CAUSAL RELATIONSHIP TO THE SHORTCUT DEVICE AND/OR THE ASSOCIATED PROCEDURE CANNOT BE RULED OUT.