BIOCOR/EPIC SIZER SET
Received Mar 18, 2024 · Event occurred Feb 22, 2024
Report 2135147-2024-01200 · MDR key 18923502
Device
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
69 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVENT OF SIZER SET BEING TOO BULKY WAS REPORTED. A RETURNED DEVICE ASSESSMENT INCLUDING A DIMENSIONAL ANALYSIS OF THE SIZER SET COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED. INFORMATION FROM THE FIELD INDICATED THAT THE REPLICA END OF THE SIZER SUBSEQUENTLY GOT STUCK AT THE LEVEL OF THE ANNULUS AND THERE WAS EXTREME DIFFICULTY REMOVING THE SIZER FROM THE AORTIC ROOT. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT CONCLUSIVELY BE DETERMINED.
Additional Manufacturer Narrative
INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT ON 21 FEBRUARY 2024, A 25MM EPIC MAX VALVE WAS CHOSEN FOR A PROCEDURE USING EPIC MAX HEART VALVE SIZER SET. THE PATIENT HAD AN NON-ABBOTT VALVE IMPLANTED 2 PRIOR AND HAD ENDOCARDITIS WHICH REQUIRED A DEVICE REPLACEMENT. THE PREVIOUSLY IMPLANTED NON-ABBOTT TRANSCATHETER VALVE WAS REMOVED. IT WAS NOTED THAT THE SIZER WAS BULKY AND IT WAS POSSIBLE TO GET THE REPLICA END OF THE 25 MM SIZER DOWN TO THE ANNULUS. THE REPLICA END OF THE SIZER SUBSEQUENTLY GOT STUCK AT THE LEVEL OF THE ANNULUS AND THERE WAS EXTREME DIFFICULTY REMOVING THE SIZER FROM THE AORTIC ROOT. THE SIZER WAS HARD PLASTIC WITH NO FLEX, IT NEARLY TORN THE AORTA WHEN ATTEMPTING TO REMOVE THE SIZER. A SMALL SEGMENT OF PATIENT'S ASCENDING AORTA HAD TO BE REPLACED WITH A SYNTHETIC GRAFT MATERIAL USING AN AORTOPLASTY DUE TO POOR NATIVE TISSUE QUALITY (CALCIFICATION AND FRIABLE TISSUE) IN ORDER TO ACHIEVE A HEMOSTATIC CLOSURE OF THE AORTA. THE 25 MM EPIC MAX VALVE WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN MENTIONED THERE WAS NO ISSUE WITH THE IMPLANTED VALVE. THERE WAS A DELAY OF 5-10 MINUTES IN THE PROCEDURE DUE TO THIS ISSUE. IT TOOK EXTRAORDINARILY LONG FOR THE PATIENT'S HEART TO BEGIN CONTRACTING NORMALLY AS THEY WERE COMING OFF BYPASS, I.E. ~2 HOURS. THE PHYSICIAN MENTIONED THERE WAS NO ISSUE WITH THE IMPLANTED VALVE. THE PATIENT WAS REPORTED AS STABLE. THE PATIENT WAS DISCHARGE TO A SKILLED NURSING FACILITY IN STABLE CONDITION.