Description of Event or Problem · 1
THE FOLLOWING WAS REPORTED IN THE JOURNAL OF CARDIOVASCULAR REVASCULARIZATION MEDICINE IN "CORONARY ARTERY ANEURYSM FORMATION AFTER DRUG-ELUTING STENT IMPLANTATION", VOLUME 9, ISSUE 4, OCTOBER-DECEMBER 2008, PAGES 284-287: THE PATIENT INITIALLY PRESENTED WITH SEVERE CHEST PAIN RADIATING TO BOTH ARMS. AN ECG IN THE EMERGENCY DEPARTMENT SHOWED ACUTE ANTEROSEPTAL ST-SEGMENT ELEVATION. THE PATIENT UNDERWENT EMERGENT CORONARY ANGIOGRAPHY (CAG), WHICH REVEALED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) BRANCH OCCLUSION. HE WAS TREATED WITH REOPRO AND STENTING OF THE PROXIMAL LAD WITH A 3.5 X 12MM EXPRESS STENT. A RESIDUAL 60% MID-LAD LESION AND A 30% DISTAL RIGHT CORONARY ARTERY (RCA) LESION WERE NOTED BUT NOT TREATED. SIX MONTHS LATER, THE PATIENT HAD ATYPICAL CHEST PAIN & BILATERAL ARM PARESTHESIAS. REPEAT CAG REVEALED A PATENT PROXIMAL LAD STENT, PROGRESSION OF THE MID-LAD LESION TO 70% STENOSIS AND A 95% DISTAL RCA LESION. THE PATIENT UNDERWENT DIRECT STENTING OF THE LAD WITH A 3.0 X 8MM CYPHER STENT AND OF THE RCA WITH A 3.0 X 8MM CYPHER STENT. THREE MONTHS LATER, THE PATIENT HAD ACUTE SHORTNESS OF BREATH AND RECURRENT CHEST PAIN. DIAGNOSTIC CAG REVEALED ALL THREE STENTS TO BE WIDELY PATENT; HOWEVER, LARGE (5-7 MM) ANEURYSMS WERE SEEN AT THE SITE OF THE PREVIOUSLY PLACED CYPHER STENT (BUT NOT AT THE SITE OF THE BMS). THE DECISION WAS MADE TO CONSERVATIVELY FOLLOW THE AREAS OF THE ANEURISMAL DILATION AND THE PATIENT WAS SCHEDULED FOR REPEAT CAG AT 1 YEAR. REPEAT CAG AT THAT TIME REVEALED A NORMAL PROXIMAL LAD STENT WITH WORSENING ANEURISMAL DILATION IN THE AREAS OF THE MID-LAD AND DISTAL RCA PREVIOUSLY TREATED WITH CYPHER STENTS. INTRAVASCULAR ULTRASOUND (IVUS) IMAGING SHOWED A 6.0-MM ANEURYSM IN THE MID-LAD WITH NON-OPPOSED STENT STRUTS IN THE MID AND DISTAL PORTIONS. SIMILARLY, IVUS IMAGING OF THE RCA SHOWED A 6.3-MM AREA OF ANEURISMAL DILATION. THE PATIENT REMAINS ASYMPTOMATIC AND IS BEING FOLLOWED CONSERVATIVELY WITH MEDICAL MANAGEMENT INCLUDING ASPIRIN & CLOPIDOGREL. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBER IS 3003742446-2009-00041. AS REPORTED IN THE LITERATURE; THIS MALE EXPERIENCED CORONARY ANEURYSM POST IMPLANTATION OF A CYPHER STENT. MEDICAL HISTORY INCLUDED KNOWN CORONARY DISEASE WITH PRIOR PCI (EXPRESS BARE METAL STENT IN THE PROXIMAL LAD), HYPERTENSION, HYPERLIPIDEMIA AND BORDERLINE DIABETES. DURING THE INDEX PROCEDURE, ONE 3.0/8MM CYPHER WAS IMPLANTED IN A 70% MID-LAD STENOSIS AND ONE 3.0/18MM CYPHER WAS IMPLANTED IN A 95% DISTAL RCA STENOSIS. NO OTHER PROCEDURAL DETAILS WERE PROVIDED BUT NO COMPLICATIONS WERE REPORTED. THREE MONTHS LATER, HE WAS READMITTED WITH ACUTE SHORTNESS OF BREATH AND RECURRENT CHEST PAIN. ANGIOGRAPHY REVEALED ALL THREE STENTS TO BE WIDELY PATENT; HOWEVER, LARGE (5-7 MM) ANEURYSMS WERE SEEN AT THE SITE OF THE PREVIOUSLY PLACED CYPHER STENTS (BUT NOT AT THE SITE OF THE BMS). THE DECISION WAS MADE TO CONSERVATIVELY FOLLOW THE AREAS OF THE ANEURISMAL DILATION AND THE PATIENT WAS SCHEDULED FOR REPEAT ANGIOGRAPHY AT 1 YEAR. REPEAT ANGIOGRAPHY AT THAT TIME REVEALED A NORMAL PROXIMAL LAD STENT WITH WORSENING ANEURYSMAL DILATION IN THE AREAS OF THE MID-LAD AND DISTAL RCA PREVIOUSLY TREATED WITH CYPHER STENTS. INTRAVASCULAR ULTRASOUND IMAGING SHOWED A 6.0-MM ANEURYSM IN THE MID-LAD WITH NONOPPOSED STENT STRUTS IN THE MID AND DISTAL PORTIONS. SIMILARLY, IVUS IMAGING OF THE RCA SHOWED A 6.3-MM AREA OF ANEURYSMAL DILATION. THE PATIENT REMAINS ASYMPTOMATIC AND IS BEING FOLLOWED CONSERVATIVELY WITH MEDICAL MANAGEMENT INCLUDING ASPIRIN AND CLOPIDOGREL. THE STENTS COULD NOT BE RETURNED FOR EVALUATION; THEY REMAINED IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. CORONARY ANEURYSM IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. AFTER REVIEW OF THE AVAILABLE INFORMATION, IT IS NOT KNOWN WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT.