SHORTCUT

Additional Manufacturer Narrative

THE EVENT OCCURRED DURING A PLANNED DUAL LEAFLET SPLITTING PROCEDURE ON A PREVIOUSLY IMPLANTED EVOLUT VALVE. THE PATIENT WAS SUPPORTED BY ECMO. FOLLOWING SUCCESSFUL SPLITTING OF THE RC LEAFLET, THE TEAM ATTEMPTED TO POSITION THE DEVICE FOR THE LC SPLIT. DURING POSITIONING OVER THE LC CUSP, A PERICARDIAL EFFUSION WAS IDENTIFIED AND CONFIRMED TO BE A HEMOPERICARDIUM, PROMPTING CONVERSION TO OPEN SURGERY. THE EVOLUT VALVE WAS EXPLANTED, AND AN AORTIC ROOT INJURY WAS DETECTED NEAR THE RCC/NCC COMMISSURE. THE INJURY WAS REPAIRED, AND A NEW VALVE WAS IMPLANTED. THE PATIENT RECOVERED WITHOUT RESIDUAL INJURY. A THOROUGH INVESTIGATION WAS CONDUCTED, INCLUDING PROCEDURAL REVIEW, IMAGING ANALYSIS, DEVICE TESTING, AND BATCH RECORD REVIEW. NO DEVICE MALFUNCTION OR MANUFACTURING NONCONFORMITIES RELATED TO THE INCIDENT WERE IDENTIFIED. VISUAL INSPECTION REVEALED A DENT IN THE SPLITTING ELEMENT (SE), LIKELY RESULTING FROM REPEATED INTERACTION WITH THE EVOLUT VALVE FRAME. THIS DAMAGE INDICATES THAT EXCESSIVE PUSHING MAY ALLOW THE SE TO ADVANCE THROUGH THE EVOLUT VALVE FRAME, RISKING VASCULAR INJURY. FUNCTIONAL TESTING CONFIRMED THAT THE DEVICE MET ALL PERFORMANCE SPECIFICATIONS. THE INVESTIGATION INCLUDED A REVIEW OF THE PROCEDURAL STEPS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU), WHICH WERE FOUND TO BE ADEQUATE AND CLEAR. THE PROCEDURAL REVIEW SUGGESTED THAT CERTAIN KEY STEPS MAY NOT HAVE BEEN FULLY ADHERED TO, PARTICULARLY THOSE CONCERNING OPTIMAL PA POSITIONING AND THE RECOMMENDED RESPONSE TO RESISTANCE DURING ADVANCEMENT. MANIPULATION OF THE DEVICE TO FACILITATE ADVANCEMENT WAS OBSERVED DURING POSITIONING, DESPITE RECOMMENDATIONS TO AVOID SUCH MANEUVERS WHEN RESISTANCE IS ENCOUNTERED DUE TO INTERACTION WITH THE EVOLUT FRAME. THE MANUFACTURER HAS SOME EARLY CLINICAL AND COMMERCIAL EXPERIENCE WITH THE USE OF SHORTCUT IN SELF-EXPANDING VALVES. IN THESE CASES, POSITIVE OUTCOMES HAVE BEEN OBSERVED WHEN PROCEDURAL STEPS WERE CAREFULLY FOLLOWED, SUGGESTING THAT ADHERENCE TO TECHNIQUE MAY PLAY A SUPPORTIVE ROLE IN PROCEDURAL SUCCESS. THE ROOT CAUSE OF THE EVENT IS ATTRIBUTED TO A COMBINATION OF PROCEDURAL COMPLEXITY RELATED TO THE PRE-EXISTING VALVE AND USE-RELATED FACTORS (MISUSE), INCLUDING DEVIATION FROM RECOMMENDED PROCEDURAL STEPS. THE DEVICE WAS FOUND TO BE STRUCTURALLY AND FUNCTIONALLY INTACT.

Description of Event or Problem

DURING A PLANNED DUAL SPLIT PROCEDURE ON A FAILED EVOLUT VALVE, THE PATIENT WAS PROACTIVELY SUPPORTED WITH LAVA ECMO. THE RC LEAFLET WAS SUCCESSFULLY SPLIT FOLLOWING REPOSITIONING OF THE PA POSITIONING ARMS. DURING ATTEMPTS TO ENGAGE THE LC LEAFLET, A PERICARDIAL EFFUSION WAS IDENTIFIED AND CONFIRMED TO BE HEMOPERICARDIUM. THE LC SPLIT WAS ABORTED, AND ANGIOGRAPHY REVEALED AN AORTIC ROOT LEAK BEHIND THE VALVE FRAME. THE PROCEDURE WAS ELECTIVELY CONVERTED TO OPEN SURGERY, DURING WHICH THE EVOLUT VALVE WAS EXPLANTED, THE AORTIC INJURY (NEAR THE RCC/NCC COMMISSURE) WAS REPAIRED, AND A NEW EDWARDS INSPIRIS VALVE WAS IMPLANTED. THROUGHOUT THE INTERVENTION, THE PATIENT REMAINED HEMODYNAMICALLY STABLE WITH ECMO AND CARDIOPULMONARY BYPASS SUPPORT AND RECOVERED WITHOUT PERMANENT IMPAIRMENT OR RESIDUAL INJURY.