AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. IMAGE REVIEW: THE GUIDED FLUOROSCOPY IMAGE WAS A MAGNIFIED AP PROJECTION THAT DEMONSTRATED APPROXIMATELY THREE THORACIC VERTEBRAL BODIES, PART OF THE STERNUM, AND THE PROXIMAL END OF SEVERAL RIBS. THE MAGNIFIED IMAGE DEMONSTRATED A HEART VALVE OVERLYING THE THORACIC SPINE IN A PERPENDICULAR FASHION. THE PROXIMAL END OF THE HEART VALVE WAS FLARED; HOWEVER, THE REST OF THE VALVE REMAINED UNIFORM IN SIZE WITH THE DISTAL END TAPERED INWARD. TWO DISTAL TEMPORARY PACEMAKER WIRES WERE DEMONSTRATED IN THE IMAGE. THE GUIDED FLUOROSCOPY IMAGE DEMONSTRATED A PIGTAIL CATHETER DESCENDING SUPERIORLY TO THE HEART VALVE, THE DISTAL END OF THE PIGTAIL CATHETER OVERLAPPING THE PROXIMAL END OF THE HEART VALVE. BASED ON IMAGES IT CANNOT BE DETERMINED IF THE PIGTAIL CATHETER WAS INTERTWINED WITHIN THE HEART VALVE. A BALLOON CATHETER SYSTEM WITH A WIRE WAS ADVANCED BEYOND THE VALVE; THE TWO (2) MARKER BANDS FROM THE CATHETER SYSTEM WERE POSITIONED WITHIN THE VALVE AND EXTENDING FROM THE MID TO DISTAL END OF THE VALVE. THE IDENTITY OF THE BALLOON CATHETER SYSTEM CANNOT BE DETERMINED AS NO BALLOON INFLATION WITHIN THE VALVE WAS DEMONSTRATED. BASED ON THE IMAGES PROVIDED, THE PROXIMAL END OF THE HEART VALVE WAS FLARED; HOWEVER, THE REST OF THE VALVE REMAINED UNIFORM IN SIZE WITH THE DISTAL END TAPERED INWARD CAN BE CONFIRMED. BASED ON THE IMAGES PROVIDED, A BALLOON CATHETER SYSTEM WITH A WIRE ADVANCED BEYOND THE VALVE, TWO (2) MARKER BANDS WERE DEMONSTRATED TO BE POSITIONED WITHIN THE VALVE AND EXTENDING FROM THE MID TO DISTAL END OF THE VALVE CAN BE CONFIRMED. BASED ON THE IMAGES PROVIDED, THE IDENTITY OF THE BALLOON CATHETER SYSTEM CANNOT BE DETERMINED AS NO BALLOON INFLATION WITHIN THE VALVE WAS DEMONSTRATED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
D
Patient 1
IT WAS REPORTED THAT DURING A TAVR PROCEDURE ACCESS WAS GAINED THROUGH THE ARM AND A HEART VALVE WAS IMPLANTED. THE HEALTH CARE PROVIDER(HCP) USED A VALVULOPLASTY BALLOON TO POST DILATE THE VALVE. THE BALLOON INFLATED AND DEFLATED SUCCESSFULLY INSIDE THE VALVE, BUT DURING RETRACTION THE VALVULOPLASTY BALLOON ALLEGEDLY PULLED THE HEART VALVE BACK WITH IT AND OUT OF THE AORTIC VALVE, INTO THE ASCENDING AORTA. THE HCP PROCEEDED TO OPEN THE PATIENT TO RETRIEVE THE VALVE, WHICH RESULTED IN COMPLICATIONS THAT LEAD TO THE PATIENT EXPIRING.
N
Patient 1
AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. IMAGE REVIEW: THE GUIDED FLUOROSCOPY IMAGE WAS A MAGNIFIED AP PROJECTION THAT DEMONSTRATED APPROXIMATELY THREE THORACIC VERTEBRAL BODIES, PART OF THE STERNUM, AND THE PROXIMAL END OF SEVERAL RIBS. THE MAGNIFIED IMAGE DEMONSTRATED A HEART VALVE OVERLYING THE THORACIC SPINE IN A PERPENDICULAR FASHION. THE PROXIMAL END OF THE HEART VALVE WAS FLARED; HOWEVER, THE REST OF THE VALVE REMAINED UNIFORM IN SIZE WITH THE DISTAL END TAPERED INWARD. TWO DISTAL TEMPORARY PACEMAKER WIRES WERE DEMONSTRATED IN THE IMAGE. THE GUIDED FLUOROSCOPY IMAGE DEMONSTRATED A PIGTAIL CATHETER DESCENDING SUPERIORLY TO THE HEART VALVE, THE DISTAL END OF THE PIGTAIL CATHETER OVERLAPPING THE PROXIMAL END OF THE HEART VALVE. BASED ON IMAGES IT CANNOT BE DETERMINED IF THE PIGTAIL CATHETER WAS INTERTWINED WITHIN THE HEART VALVE. A BALLOON CATHETER SYSTEM WITH A WIRE WAS ADVANCED BEYOND THE VALVE; THE TWO (2) MARKER BANDS FROM THE CATHETER SYSTEM WERE POSITIONED WITHIN THE VALVE AND EXTENDING FROM THE MID TO DISTAL END OF THE VALVE. THE IDENTITY OF THE BALLOON CATHETER SYSTEM CANNOT BE DETERMINED AS NO BALLOON INFLATION WITHIN THE VALVE WAS DEMONSTRATED. BASED ON THE IMAGES PROVIDED, THE PROXIMAL END OF THE HEART VALVE WAS FLARED; HOWEVER, THE REST OF THE VALVE REMAINED UNIFORM IN SIZE WITH THE DISTAL END TAPERED INWARD CAN BE CONFIRMED. BASED ON THE IMAGES PROVIDED, A BALLOON CATHETER SYSTEM WITH A WIRE ADVANCED BEYOND THE VALVE, TWO (2) MARKER BANDS WERE DEMONSTRATED TO BE POSITIONED WITHIN THE VALVE AND EXTENDING FROM THE MID TO DISTAL END OF THE VALVE CAN BE CONFIRMED. BASED ON THE IMAGES PROVIDED, THE IDENTITY OF THE BALLOON CATHETER SYSTEM CANNOT BE DETERMINED AS NO BALLOON INFLATION WITHIN THE VALVE WAS DEMONSTRATED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
D
Patient 1
IT WAS REPORTED THAT DURING A TAVR PROCEDURE, ACCESS WAS GAINED THROUGH THE ARM AND A HEART VALVE WAS IMPLANTED. THE HEALTH CARE PROVIDER(HCP) USED A VALVULOPLASTY BALLOON TO POST DILATE THE VALVE. THE BALLOON INFLATED AND DEFLATED SUCCESSFULLY INSIDE THE VALVE, BUT DURING RETRACTION THE VALVULOPLASTY BALLOON ALLEGEDLY PULLED THE HEART VALVE BACK WITH IT AND OUT OF THE AORTIC VALVE, INTO THE ASCENDING AORTA. THE HCP PROCEEDED TO OPEN THE PATIENT TO RETRIEVE THE VALVE, WHICH RESULTED IN COMPLICATIONS THAT LEAD TO THE PATIENT EXPIRING.