FDA Adverse Event Injury Summary report: N

CYPHER SIROLIMUS-ELUTING CORONARY STENT

MDR report key: 1212597 · Received October 24, 2008

Report

Report Number: 3003742446-2008-00228
Event Type: Injury
Date Received: October 24, 2008
Date of Event: January 26, 2007
Report Date: May 12, 2010
Manufacturer: CORDIS LLC (PR)
Product Code: NIQ
PMA / PMN Number: P020026
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS FOR AN UNKNOWN CYPHER STENT. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

Additional Manufacturer Narrative · 1

PATIENT RECORDS WERE OBTAINED: THE PATIENT WAS A (B) (6) FEMALE WHO WAS ADMITTED WITH IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED TAXUS STENT IN THE PROXIMAL RCA. THE INTERVENTION WENT VERY SMOOTH AND A CYPHER STENT WAS IMPLANTED. THE STENT WAS POST-DILATED AT A HIGH PRESSURE INCLUDING THE OVERLAPPING AREA. THERE WAS NO DISSECTION OR ANY OTHER SIGN OF ANY COMPLICATION AT THE END OF THE PROCEDURE. THE PATIENT REMAINED SYMPTOM FREE. SHE WAS TRANSFERRED IN STABLE CONDITION. SUBSEQUENTLY, HOWEVER, THE PATIENT DEVELOPED CHEST PAIN AND ST ELEVATIONS AND WAS BROUGHT TO THE CARDIAC CATHETERIZATION LABORATORY. SHE WAS FOUND TO HAVE THROMBOSIS IN THE RCA, RIGHT AT THE PROXIMAL ADJUSTED STENT. A WIRE WAS EASILY PASSED THROUGH AND ASPIRATED USING A PRONTO CATHETER TO RECOVER A LARGE AMOUNT OF CLOTS. THE RCA WAS ALSO POST-DILATED WITH AN OVERSIZED BALLOON. BETWEEN THE TRANSFER AND THE PROCEDURE THE PATIENT HAD A COUPLE OF EPISODES OF VENTRICULAR FIBRILLATION, AND WAS DEFIBRILLATED SUCCESSFULLY. ALMOST ONE YEAR LATER, THE PATIENT CAME TO THE HOSPITAL FOR A FOLLOW-UP. SHE INDICATED THAT SHE FELT HER HEART ¿THUMPING AND FLUTTERING.¿ CATH SHOWED PATENT CORONARIES AND A MARKEDLY DIMINISHED EJECTION FRACTION. PHYSICIAN INDICATED THAT THERE WAS NO ACUTE PULMONARY, PARENCHYMAL, OR VASCULAR ABNORMALITY SUSPECTED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

Additional Manufacturer Narrative · 1

LATER THE SAME DAY, THE PATIENT SUDDENLY DEVELOPED CHEST PAIN AND ST ELEVATIONS. ASPIRATION THROMBECTOMY AND DILATATION OF THE RIGHT CORONARY ARTERY STENT. THE STENT WAS FLUSH OCCLUDED AT ITS PROXIMAL EDGE. ASPIRATION CATHETER WAS USED TO DO THE ASPIRATION THROMBECTOMY. AFTER THAT, THE STENTS WERE AGAIN POST-DILATED AT HIGH PRESSURE. APPROXIMATELY NINE MONTHS AFTER THE INDEX PROCEDURE, CARDIAC CATHETERIZATION WAS PERFORMED AND REVEALED THAT THE LEFT MAIN, LEFT ANTERIOR DESCENDING CORONARY ARTERY AND LEFT CIRCUMFLEX CORONARY ARTERY WERE ANGIOGRAPHICALLY NORMAL. THE RIGHT CORONARY ARTERY WAS A LARGE AND THE STENT WHICH WAS PATENT HAD MINOR DISEASE ALSO. LEFT VENTRICULOGRAPHY DEMONSTRATED A DILATED LEFT VENTRICLE. THE PATIENT HAD CARDIOMYOPATHY WITH SEVERELY IMPAIRED LEFT VENTRICULAR SYSTOLIC FUNCTION. THE PATIENT WAS STARTED ON MEDICAL THERAPY IN THE FORM OF ADDITION OF ARB, ATACAND 4MG DAILY, LASIX 40MG DAILY, POTASSIUM SUPPLEMENT, ALDACTONE 50MG DAILY. THE PATIENT WAS ALREADY ON BETA-BLOCKERS AND ACE INHIBITORS. THE PATIENT ALSO GAVE A HISTORY OF CARDIOMYOPATHY IN THE FAMILY. THE PHYSICIAN RECOMMENDED AN ICD DEVICE. INFORMATION CONTAINED IN A LEGAL FILE INDICATED THAT A PATIENT EXPERIENCED AN ACUTE THROMBOTIC EVENT, VENTRICULAR FIBRILLATION ARREST, CARDIOMYOPATHY AND AN MI AFTER HAVING A CYPHER STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR DIABETES, NOT WELL CONTROLLED, OBESITY, HYPERTENSION AND HYPERLIPIDEMIA, + FAMILY HISTORY IN CARDIOMYOPATHY. THE TARGET LESION WAS THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS TREATED APPROXIMATELY ONE YEAR EARLIER ((B)(6) 2005) WITH A TAXUS STENT. APPROXIMATELY SEVEN HOURS AFTER THE IMPLANT OF THE TAXUS STENT THE PATIENT HAD ST ELEVATIONS ON EKG AND WAS BROUGHT BACK TO THE CATH LAB. ANGIOGRAPHY REVEALED IN STENT THROMBOSIS WHICH WAS TREATED WITH ASPIRATION AND BALLOON ANGIOPLASTY. THE PATIENT WAS GIVEN ANGIOMAX FOR THE INITIAL STENT IMPLANT, AFTER THE THROMBOTIC EVENT THE PATIENT WAS GIVEN ANGIOMAX AND REO-PRO. APPROXIMATELY TWO MONTHS POST TAXUS IMPLANTATION; THE PATIENT HAS BLOOD WORK TO MONITOR ELEVATED LIVER ENZYMES. THE PATIENT COMPLAINED OF PALPITATIONS AND ANGINA SYMPTOMS, ((B)(6) 2006) AND A STRESS TEST WAS NOTED TO BE POSITIVE. THE PERSANTINE CARDIOLITE STRESS TEST WAS ABNORMAL INDICATIVE OF OBSTRUCTIVE DISEASE OF THE POSTEROLATERAL CORONARY ARTERY BRANCH AND POSSIBLY THE LAD ARTERY. APPROXIMATELY A YEAR POST TAXUS IMPLANTATION ((B)(6) 2006) THE PATIENT HAD REPEAT ANGIOGRAPHY DUE TO ANGINA AND AN ABNORMAL STRESS TEST THAT REVEALED 80% RESTENOSIS IN THE TAXUS STENT. THE LESION WAS TREATED WITH CUTTING BALLOON FOLLOWED BY THE IMPLANT OF A 3.0MM X 13MM CYPHER STENT AT 11 ATMOSPHERES FOLLOWED BY POST DILATION. THE PATIENT WAS DISCHARGED FROM THE CATH LAB IN STABLE CONDITION. APPROXIMATELY SEVEN HOURS LATER THE PATIENT HAD A CHEST PAIN, ST ELEVATIONS AND VENTRICULAR FIBRILLATION ARREST IN THE INTENSIVE CARE UNIT. THE PATIENT WAS ELECTRICALLY AND CHEMICALLY DEFIBRILLATED AND INTUBATED. THE PATIENT WAS TAKEN EMERGENTLY TO THE CATH LAB AND ANGIOGRAPHY REVEALED THROMBUS AT THE SITE OF THE IMPLANTED STENTS. THE EVENT WAS TREATED WITH ASPIRATION AND BALLOON ANGIOPLASTY, ANGIOMAX, REOPRO AND AMIODARONE DRIPS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS LATER ON DUAL ANTI-PLATELET REGIMEN. A COMMENT FOUND IN ONE OF THE DOCTORS NOTES INDICATED THAT THE PATIENT'S PLATELETS ARE NOT SENSITIVE TO THE USUAL ANTIPLATELET MEDICATIONS. TWO MONTHS POST CYPHER IMPLANTATION THE PATIENT REPORTS NO CHEST PAIN AND NO CHANGES WERE MADE TO THE MEDICATION REGIMEN. APPROXIMATELY 7 MONTHS POST CYPHER IMPLANTATION ((B)(6) 2007) THE PATIENT REPORTS NO CHEST PAIN; HOWEVER, ECG SHOWS SINUS RHYTHM WITH POOR R-WAVE PROGRESSION OVER PRECORDIAL LEADS AND THE PATIENT COMPLAINS OF SHORTNESS OF BREATH. ANGIOGRAPHY SHOWS NO SIGNIFICANT CORONARY ARTERY DISEASE WITH PATENT STENTS IN THE RIGHT CORONARY ARTERY AS WELL AS CARDIOMYOPATHY WITH SEVERELY IMPAIRED LEFT VENTRICULAR SYSTOLIC FUNCTION, EF ESTIMATED AT 15%. THE PATIENT'S MEDICATION REGIMEN WAS ADJUSTED FOR TREATMENT OF THE CARDIOMYOPATHY AND PULMONARY HYPERTENSION. ((B)(6) 2007), PHYSICIAN REVIEWED CARDIAC CATHETERIZATION: "CARDIAC CATHETERIZATION DEMONSTRATED THE CORONARY ARTERIES TO BE FREE OF ANY SIGNIFICANT FOCAL STENOSIS. THE RIGHT CORONARY STENTS WERE PATENT. HOWEVER, SHE HAD MODERATELY SEVERE PULMONARY HYPERTENSION, SECONDARY TO SEVERE ISCHEMIC CARDIOMYOPATHY. THE LEFT VENTRICULAR ANGIOGRAM DEMONSTRATED A LARGE ANTEROAPICAL OLD INFARCT. THE REST OF THE LEFT VENTRICLE WAS HYPOKINETIC. THERE WAS NO SIGNIFICANT MITRAL REGURGITATION. THE LEFT VENTRICULAR EJECTION FRACTION WAS ESTIMATED AT 15%. THE ELECTROCARDIOGRAM DEMONSTRATES ABNORMAL T-WAVES IN THE INFERIOR LEADS AND POOR PROGRESSION OF R-WAVES ACROSS THE PRECORDIAL LEADS, INDICATING AN EXTENSIVE INFEROANTERIOR MYOCARDIAL INFARCTION. THE REST OF THE LEFT VENTRICLE IS ALSO HYPOKINETIC. THERE IS NO SIGNIFICANT MITRAL REGURGITATION. IT WOULD APPEAR THAT SHE HAS SEVERE ISCHEMIC CARDIOMYOPATHY. THIS IS MOST LIKELY SECONDARY TO THE CLOSURE OF HER STENT AND ASSOCIATED MULTIPLE RISK FACTORS FOR CORONARY DISEASE. HOWEVER, THE ISCHEMIC CARDIOMYOPATHY MAY BE SUPER IMPOSED ON A FAMILIAL DILATED CARDIOMYOPATHY AS WELL. PLAN: IN VIEW OF THE ABOVE FINDINGS, SHE IS AT INCREASED RISK FOR SUDDEN CARDIAC DEATH AND MAY BENEFIT FROM RECEIVING AN ICD DEVICE FOR PRIMARY PREVENTION OF THIS EVENT. SHE UNDERSTANDS THE PROS AND CONS OF THIS THERAPY AND SHE AND HER HUSBAND WISH TO PROCEED WITH THESE RECOMMENDATIONS. IN (B)(6) 2009, APPROXIMATELY 3 YEARS POST CYPHER IMPLANTATION THE PATIENT HAS AN ECG THAT INDICATED AN INFERIOR MI. THERE IS NO INFORMATION REGARDING FURTHER DIAGNOSIS OR TREATMENT FOR THIS EVENT. THERE IS NO INFORMATION REGARDING THE TIMING OF THIS MI EVENT. THERE IS NO INFORMATION IF THIS IS AN OLD PHENOMENON OR AN ACUTE CHANGE. THE CYPHER STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 40106417 PRESENTED NO ISSUES DURING THE MANUFACTURING AND INSPECTION PROCESSES. NO ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ARRHYTHMIA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION AND ARE LISTED IN THE IFU AS SUCH. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE INHERENT CHANGES IN CORONARY BLOOD FLOW ASSOCIATED WITH INVASIVE AND INTERVENTIONAL PROCEDURES MAY CONTRIBUTE TO DISTURBANCES IN THE NORMAL CARDIAC ELECTRICAL FUNCTIONING RESULTING IN ARRHYTHMIAS. IN THIS CASE, THE INDEX LESION WAS IN THE RCA IN THE FACE OF AN ACUTE STENT CLOSURE, MAKING THE PATIENT MUCH MORE PRONE TO ISCHEMIC RELATED ARRHYTHMIAS. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. THE PROCEDURE THE PATIENT WAS TREATED WITH ANTI-PLATELET MEDICATIONS. MI IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THROMBOTIC OR RESTENOSIS EVENTS WHEREIN THE INNER LUMEN OF THE CORONARY ARTERY BECOMES NARROWED AND BLOOD FLOW DECREASED. THE MYOCARDIAL TISSUES ARE STARVED OF OXYGEN AND OTHER NUTRIENTS SECONDARY TO THE DECREASED OR STOPPED BLOOD FLOW AND IT CAUSES PERMANENT CARDIAC DAMAGE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. CARDIOMYOPATHY IS A DISEASE THAT WEAKENS AND ENLARGES THE HEART MUSCLE. THERE ARE THREE MAIN TYPES OF CARDIOMYOPATHY "DILATED, HYPERTROPHIC AND RESTRICTIVE " ALL OF WHICH AFFECT YOUR HEART MUSCLE. CARDIOMYOPATHY MAKES IT HARDER FOR THE HEART TO PUMP BLOOD AND DELIVER IT TO THE REST OF THE BODY. THERE ARE MANY CAUSES OF CARDIOMYOPATHY, INCLUDING CORONARY ARTERY DISEASE AND VALVULAR HEART DISEASE. CARDIOMYOPATHY CAN LEAD TO HEART FAILURE. CARDIOMYOPATHY CAN OCCUR POST MYOCARDIAL INFARCTION, WHERE THE AFFECTED AREA STOPS CONTRACTING, CREATING A DILATED AREA OF THE LEFT VENTRICLE. IN THIS CASE IT IS UNKNOWN IF THE PATIENT'S CARDIOMYOPATHY WAS DILATED OR RESTRICTIVE, OR A COMBINATION OF BOTH FACTORS. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND LESION ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED UNFORTUNATE EVENTS.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

Additional Manufacturer Narrative · 1

INFORMATION CONTAINED IN A LEGAL FILE INDICATED THAT A PATIENT EXPERIENCED AN ACUTE THROMBOTIC EVENT AND VENTRICULAR FIBRILLATION ARREST AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR DIABETES, NOT WELL CONTROLLED, OBESITY, HYPERTENSION AND HYPERLIPIDEMIA. THE TARGET LESION WAS THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS TREATED APPROXIMATELY ONE YEAR EARLIER WITH A TAXUS STENT. APPROXIMATELY SEVEN HOURS AFTER THE IMPLANT OF THE TAXUS STENT, THE PATIENT HAD ST ELEVATIONS ON EKG AND WAS BROUGHT BACK TO THE CATH LAB. ANGIOGRAPHY REVEALED IN STENT THROMBOSIS WHICH WAS TREATED WITH ASPIRATION AND BALLOON ANGIOPLASTY. THE PATIENT WAS GIVEN ANGIOMAX FOR THE INITIAL STENT IMPLANT, AFTER THE THROMBOTIC EVENT, THE PATIENT WAS GIVEN ANGIOMAX AND REO-PRO. APPROXIMATELY A YEAR LATER, THE PATIENT REPEAT ANGIOGRAPHY WAS PERFORMED DUE TO ANGINA AND AN ABNORMAL STRESS TEST AND REVEALED 80% RESTENOSIS IN THE TAXUS STENT. THE LESION WAS TREATED WITH CUTTING BALLOON FOLLOWED BY THE IMPLANT OF A 3.0MM X 13MM CYPHER STENT AT 11 ATMOSPHERES FOLLOWED BY POST DILATION. THE PATIENT WAS DISCHARGED FROM THE CATH LAB IN STABLE CONDITION. APPROXIMATELY SEVEN HOURS LATER, THE PATIENT HAD A VENTRICULAR FIBRILLATION ARREST IN THE INTENSIVE CARE UNIT. THE PATIENT WAS ELECTRICALLY AND CHEMICALLY DEFIBRILLATED AND INTUBATED. THE PATIENT WAS TAKEN EMERGENTLY TO THE CATH LAB AND ANGIOGRAPHY REVEALED THROMBUS AT THE SITE OF THE IMPLANTED STENTS. THE EVENT WAS TREATED WITH ASPIRATION AND BALLOON ANGIOPLASTY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS LATER. A COMMENT FOUND IN ONE OF THE DOCTORS NOTES INDICATED THAT THE PATIENT¿S PLATELETS ARE NOT SENSITIVE TO THE USUAL ANTIPLATELET MEDICATIONS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 40106417 PRESENTED NO ISSUES DURING THE MANUFACTURING AND INSPECTION PROCESSES. NO ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ACUTE STENT THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE VENTRICULAR FIBRILLATION ARRESTS THE PATIENT EXPERIENCED IS RELATED TO THE THROMBOTIC EVENT. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.