BIOCOR/EPIC SIZER SET

Additional Manufacturer Narrative

AN EVENT OF EXPLANT OF THE DEVICE WAS REPORTED. THE INVESTIGATION FOUND A 1 MM TEAR IN THE FREE EDGE OF CUSP 1 AT THE TOP OF THE STENT POST SHARED WITH CUSP 3. THERE WAS AN IRREGULAR 3 BY 3-INCH TEAR IN THE MID PORTION OF THE CUSP BASE. THERE WAS A 4 MM TEAR IN THE FREE EDGE OF CUSP 2 AT THE STENT POST SHARED WITH CUSP 3 WITH A THINNING AND LOSS OF COLLAGEN FIBERS AT THE SITE OF THE TEAR. THERE WAS A 12 MM TEAR IN THE FREE EDGE/BASE OF CUSP 3 ALONG THE STENT POST SHARED WITH CUSP 1 WITH A THINNING AND LOSS OF COLLAGEN FIBERS AT THE SITE OF THE TEAR. THE DEVICE SERIAL NUMBER WAS NOT PROVIDED, AND THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE CAUSE OF THE TORN CUSPS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE DEGENERATIVE CHANGES NOTED TO THE TISSUE COULD HAVE CONTRIBUTED TO THE TEAR FORMATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

Description of Event or Problem

IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT HAD A DOUBLE VALVE REPLACEMENT (DVR) AND TAP (TRICUSPID ANNULOPLASTY), AN UNKNOWN SIZE EPIC VALVE WAS IMPLANTED IN THE MITRAL VALVE AND AN UNKNOWN SIZE TRIFECTA VALVE IN THE AORTIC VALVE IN THE PROCEDURE. ON (B)(6) 2024, A REOPERATION WAS PERFORMED, AND ONLY EPIC WAS REMOVED.

Additional Manufacturer Narrative

THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.