Description of Event or Problem · 1
THE AREA SALES MANAGER CALLED IN ON 01/09/04 TO REPORT AN INCIDENT THAT WAS HEARD THROUGH THE "GRAPEVINE" BY THE CLINICAL SPECIALIST ALSO ON 01/09/04 (THE REFERRING PHYSICIAN'S PARTNER MENTIONED IT TO THEM). THE ORIGINAL FRONTRUNNER PROCEDURE WAS DONE IN 2003. THE CLINICAL SPECIALIST WAS PRESENT FOR THIS SUCCESSFUL RIGHT CORONARY ARTERY (RCA) CHRONIC TOTAL OCCLUSION (CTO). IN 2004 THE CLINICAL SPECIALIST WAS TOLD THAT POST PROCEDURE IN 2003 THE PT WENT TO SURGERY AND SUBSEQUENTLY DIED. FROM THE ORIGINAL CASE REPORT AT THE TIME OF THE PROCEDURE (2003): PT WITH A 30MM CTO OF THE RCA AND THIS WAS THE PHYSICIAN'S FIRST CASE WITH THE FRONTRUNNER. THE PHYSICIAN GOT THROUGH THE CTO USING THE FRONTRUNNER FBS-3900 (X39) AND MICROGUIDE (MGC) AS WELL AS A CHOICE PT GUIDE WIRE AND SHINOBI WIRE. A 3.5X33MM CYPHER STENT WAS DEPLOYED IN THE CTO AFTER A 2.5X20 OPENSAIL X3. A ZETA STENT WAS DEPLOYED IN THE RAGGED MID RCA PROXIMAL TO THE CTO. IT WAS DIFFICULT BUT SUCCESSFUL FIRST PROCEDURE BY THIS PHYSICIAN. THIS INITIAL CASE WAS PROCTORED BY A SECOND PHYSICIAN WHO ATTENDED A LUMEND TRAINING PROGRAM AND HAD DONE APPROXIMATELY FIVE FRONTRUNNER PROCEDURES. IN 2004, AFTER HEARING THE RUMOR, THE AREA SALES MANAGER SPOKE WITH CATH LAB MANAGER TO FOLLOW UP ON THIS INCIDENT AND TRY TO OBTAIN ADDITIONAL DETAIL. LUMEND'S CHIEF MEDICAL OFFICER REVIEWED THE FILMS FROM BOTH THE ORIGINAL PROCEDURE AND THE RETURN TO THE CATH LAB LATER THAT EVENING. THEY SPOKE WITH THE PHYSICIAN THE FOLLOWING MONTH TO DISCUSS THE DETAILS OF THE CASE. CASE REPORT AFTER DISCUSSION WITH PHYSICIAN, AND REVIEW OF THE CD'S: THE PT HAD A MID TO DISTAL RCA CTO WITH LEFT TO RIGHT COLLATERALS THAT HAD BEEN ATTEMPTED AT ANOTHER HOSPITAL WITHIN A FEW WEEKS PREVIOUSLY. THEY CONTINUED TO HAVE ANGINA AND WERE SENT FOR ANOTHER ATTEMPT AT RECANALIZATION OF THE RCA. A GUIDE WIRE WAS USED AGAIN UNSUCCESSFULLY, THEN THE X39 AND MCG WERE USED TO NEGOTIATE THROUGH THE CTO, BEYOND THE DISTAL CAP. THERE WAS NO FLOW AFTER REMOVING THE X39, AND GUIDE WIRES WERE USED TO LOCATE THE DISTAL TRUE LUMEN. ULTIMATELY A GUIDE WIRE WAS PLACED IN THE DISTAL POSTEROLATERAL BRANCH, AND AFTER BALLOON ANGIOPLASTY, FLOW WAS RESTORED TO THAT ARTERY. A GUIDE WIRE WAS ASLO PLACED IN THE "PDA", AND DILATED, BUT NO FLOW COULD BE ESTABLISHED IN THAT VESSEL. IVUS CONFIRMED TRUE LUMEN PLACEMENT, AND THE VESSEL WAS STENTED OVER A LONG SEGMENT, WITH TIMI 2 FLOW DISTALLY, PT WAS PLACED ON GP2B3A INHIBITION AND WAS STABLE LEAVING THE CATH LAB. THAT EVENING, THE PT'S HEART RATE AND BLOOD PRESSURE FELL. PT WAS TAKEN BACK TO THE LAB WITH RELATIVELY STABLE HEMODYNAMICS, AND THE VESSEL APPEARED OPEN AND UNCHANGED FROM THE PRIOR PROCEDURE. NO PERFORATION OR VESSEL LEAK COULD BE SEEN. TRANS ESOPHAGEAL ECHOCARDIOGRAM (TEE) DEMONSTRATED A "BIZARRE" LOCALIZED CLOT VS HEMATOMA PRESSING ON THE LEFT ATRIUM. THERE WAS A SMALL TO MODERATE PERICARDIAL EFFUSION. THE DECISION WAS MADE TO OPERATE, AND EN ROUTE TO THE OR, THE PT HAD A BRADYCARDIC EVENT, WITH FALL IN BLOOD PRESSURE. AFTER ARRIVING IN THE OR, THE CHEST WAS OPENED, AND A SMALL TO MODERATE AMOUNT OF BLOOD WAS FOUND IN THE PERICARDIAL SPACE. PT WAS PLACED ON BYPASS AND THE LEFT VENTRICLE APPEARED TO NOT FUNCTION. THERE WAS NO ACTIVE BLEED FOUND IN THE OR. THE LEFT VENTRICLE NEVER RECOVERED FUNCTION, AND THE ETIOLOGY WAS NOT CLEAR. BY THE NEXT DAY. PT DEVELOPED A COAGULAOPATHY WHILE ON BYPASS, AND BEGAN BLEEDING FROM "EVERYWHERE". ULTIMATELY LIFE SUPPORT WAS WITHIDRAWN, AND PT EXPIRED. DISCUSSION: THERE WAS CLEARLY A PERFORATION OF THE RCA DURING REVASCULARIZATION, THOUGH NOT CLEAR WHEN IT OCCURRED OR WHETHER IT WAS FROM GUIDE WIRE MANIPULATION OR FROM THE FRONTRUNNER. IT WAS FELT MOST LIKELY TO BE A SMALL PUNCTURE THAT BLEED SLOWLY, EXACERBATED BY GP2B3A PLATELET INHIBITION, WITH HEMODYNAMIC COLLAPSE, FROM WHICH THE PT NEVER RECOVERED, ULTIMATELY SUCCUMBING TO A COAGULOPATHY INDUCED FROM MEDICATIONS AND BYPASS.