THE SAFARI2 GUIDEWIRE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. ADDITIONALLY THE END USER DID NOT PROVIDE LOT TRACEABILITY. THE LACK OF LOT TRACEABILITY PREVENTS PERFORMING A DEVICE HISTORY RECORDS REVIEW FOR ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THAT DURING MANUFACTURING AND PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE COMPLAINT NARRATIVE NOTED, "1ST DEPLOYMENT OF THE LOTUS VALVE NOT SATISFACTORY. PARTIAL RECAPTURE FOR A NEW DEPLOYMENT." AND, "COMPLICATION AS A RESULT OF A WRONG POSITION OF THE SAFARI GUIDE AND THE LOTUS NOSCONE." THIS REPORTED EVENT IS LISTED IN THE DIRECTIONS FOR USE AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVI/TAVR PROCEDURE. AS FURTHER INDICATED IN THE DEVICE INSTRUCTIONS FOR USE (DFU) WARNINGS, "* MONITOR WIRE POSITION THROUGHOUT THE PROCEDURE FOR PROPER PLACEMENT OF THE CURVE AND DISTAL TIP. * WHEN ADVANCING OR REMOVING THE GUIDEWIRE, ALWAYS USE FLUOROSCOPIC GUIDANCE WITH RADIOGRAPHIC EQUIPMENT THAT PROVIDES HIGH-RESOLUTION IMAGES. NEVER POSITION THE GUIDEWIRE BLINDLY AS THIS MAY RESULT IN MISPLACEMENT, DISSECTION OR PERFORATION. * THE CURVE OF THE SAFARI2 GUIDEWIRE SHOULD BE CONSTRAINED WITHIN A CATHETER DURING INSERTION INTO OR WITHDRAWAL FROM THE BODY OR TREATMENT SITE." AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED OR THE PRODUCT IS RETURNED FOR ANALYSIS A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.
D
Patient 1
THE PATIENT WAS UNDERGOING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE (TAVR) AS REPORTED BY THE DISTRIBUTOR: EVENT DESCRIPTION: IT WAS REPORTED THAT: 1ST DEPLOYMENT OF THE LOTUS VALVE NOT SATISFACTORY. PARTIAL RECAPTURE FOR A NEW DEPLOYMENT. RAPID DECREASE IN THE PATIENT'S BLOOD PRESSURE. EMERGENCY CARDIAC ULTRASOUND PERFORMED URGENTLY SHOWING A HEMOPERICARDIUM. DECISION TO NOT IMPLANT THE LOTUS VALVE. PERICARDIAL DRAINAGE SHOWING A CONTINUOUS FLOW AND MOTIVATING THE DECISION OF A SURGICAL PROCEDURE. AFTER STERNOTOMY THE SURGEON NOTICES A PERFORATION OF THE LEFT VENTRICLE NEAR THE LEFT ATRIUM. PATIENT DIES ON TABLE AFTER RESUSCITATION FAILURE. ADDITIONAL INFORMATION:: HOW DID THE PROCEDURE END? PATIENT DEATH. COMPLICATION AS A RESULT OF A WRONG POSITION OF THE SAFARI GUIDE AND THE LOTUS NOSECONE. RESPONSE TO ADDITIONAL QUESTIONS: HOW WAS THE SAFARI2 POSITIONED INCORRECTLY AND HOW DID IT CONTRIBUTE TO THE ADVERSE PATIENT EVENTS? SAFARI WAS TOO DEEP AND TOUCHED ATRIAL WALL. WHEN DURING THE PROCEDURE WAS THE SAFARI2 POSITIONED INCORRECTLY? DURING FIRST DEPLOYMENT. WHEN DURING THE PROCEDURE WAS THERE AN ISSUE WITH THE LOTUS EDGE NOSECONE? NOSECONE TOUCHED ATRIAL WALL DUE TO THE SAFARI. SAFARI2 LOT #? UNKNOWN. ARE ANY DEVICES EXPECTED TO RETURN FOR ANALYSIS? IF NO, WHY NOT? TEAM THROWED IN PIN ALL DEVICES