CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00294
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- December 17, 2010
- Report Date
- October 18, 2010
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
RESTENOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING STENT IMPLANTATION AND ARE OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S AGGRESSIVE PROGRESSION OF CORONARY ARTERY DISEASE, RISK FACTORS PRESENT IN THE MEDICAL HISTORY (DIABETES, HYPERTENSION AND PERIPHERAL VASCULAR DISEASE) AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THESE EVENTS. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. THIS IS ONE OF TWO (2) REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00293 AND 3003742446-2010-00294.
ADDITIONAL EVENT REPORTED FOR THIS PATIENT. ADDITIONAL INFORMATION WIL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO (2) REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00293 AND 3003742446-2010-00294.
THIS IS ONE OF TWO (2) REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00293 AND 3003742446-2010-00294. UPDATED COMPLAINT CONCLUSION: INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED ANGINA, RESTENOSIS AND CONGESTIVE HEART FAILURE AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, CORONARY ARTERY BYPASS GRAFT SURGERY (THREE YEARS PRIOR TO THE INDEX PROCEDURE), ISCHEMIA, PERIPHERAL ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, DIABETES AND UNKNOWN ALLERGIES. THE INDICATION FOR THE PROCEDURE WAS ANGINA WITH A POSITIVE STRESS TEST. THE TARGET LESIONS WERE THE PROXIMAL AND DISTAL CIRCUMFLEX ARTERY (CFX). THE DISTAL CFX WAS DESCRIBED AS DE NOVO, AND 95% STENOSED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.5MM X 13MM CYPHER RX STENT AT 12 ATMS. THE STENT WAS NOT POST-DILATED AND THE REPORTED RESIDUAL STENOSIS WAS 0%. THE PROXIMAL CFX WAS DESCRIBED AS DE NOVO, OSTIAL AND 90% STENOSED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.5MM X 13MM CYPHER RX STENT AT 16ATMS. THE STENT WAS NOT POST-DILATED AND THE REPORTED RESIDUAL STENOSIS WAS 0%. APPROXIMATELY TWO MONTHS LATER, THE PATIENT WAS DIAGNOSED WITH A NON-ST SEGMENT MI RESULTING IN REPEAT ANGIOGRAPHY WHICH REVEALED RESTENOSIS IN THE PROXIMAL CFX. THE EVENT WAS TREATED WITH THE IMPLANT OF ANOTHER DRUG ELUTING STENT. THE PATIENT CONTINUED TO HAVE CHEST PAIN SO REPEAT ANGIOGRAPHY WAS PERFORMED THE FOLLOWING DAY, ANGIOGRAPHY REVEALED STENOSIS AT THE OSTIAL CIRCUMFLEX DESCRIBED AS A "FLAP." ADDITIONAL BALLOON ANGIOPLASTY WAS PERFORMED ON THE PROXIMAL CFX WITH A CUTTING BALLOON, THEN PTCA BALLOON AND THEN FOLLOWED AGAIN BY CUTTING BALLOON. APPROXIMATELY FIVE MONTHS AFTER THE INDEX PROCEDURE THE PATIENT EXPERIENCED ANOTHER NON-ST ELEVATED MI. REPEAT ANGIOGRAPHY WAS PERFORMED AND REVEALED A NEW LESION IN THE FIRST AND SECOND OBTUSE MARGINALS AND RESTENOSIS OF THE PROXIMAL AND DISTAL CFX ARTERIES. THE DISTAL LCX WAS TREATED WITH PLACEMENT OF AN ADDITIONAL DRUG-ELUTING STENT. THE PROXIMAL LCX AND OM1 WERE TREATED WITH BALLOON ANGIOPLASTY ONLY. AND FINALLY, THE OM2 WAS TREATED WITH PLACEMENT OF A DRUG-ELUTING STENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT APPROXIMATELY SEVEN MONTHS POST INDEX PROCEDURE THE PATIENT PRESENTED WITH NON ST-ELEVATION MI. RESTENOSIS WAS NOTED WITHIN THE CYPHER STENT IN THE PROXIMAL LCX AND THE DISTAL CFX. THE PATIENT UNDERWENT TRANSMYOCARDIAL LASER SURGERY AND WAS EVENTUALLY DISCHARGED. APPROXIMATELY NINE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND WAS DIAGNOSED WITH CONGESTIVE HEART FAILURE. THE EVENT WAS TREATED WITH THE ADMINISTRATION OF DIURETICS, AND MEDICATION ADJUSTMENTS, NO INVASIVE TESTING WAS PERFORMED. THE SITE INDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE STENT IN THE PROXIMAL CFX, AS NO FURTHER INTERVENTION HAD BEEN PERFORMED ON THE LESION SINCE THE LAST RESTENOSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. RESTENOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING STENT IMPLANTATION AND ARE OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S AGGRESSIVE PROGRESSION OF CORONARY ARTERY DISEASE, RISK FACTORS PRESENT IN THE MEDICAL HISTORY (DIABETES, HYPERTENSION AND PERIPHERAL VASCULAR DISEASE) AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THESE EVENTS. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. CONGESTIVE HEART FAILURE AND ANGINA ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE PROGRESSION OF CORONARY ARTERY DISEASE. THE PATIENT'S MEDICAL HISTORY AND RETICENT LESION IN THE PROXIMAL CIRCUMFLEX ARTERY ARE MOST LIKELY THE CONTRIBUTING FACTORS TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.
ADDITIONAL INFORMATION WAS RECEIVED ON 3/7/2012 FROM THE CEC ADJUDICATION MINUTES INDICATING THAT THERE WAS TARGET LESION REVASCULARIZATION ON (B)(6) 2010. THIS WAS PREVIOUSLY REPORTED AS NON-TARGET LESION REVASCULARIZATION AND WAS, THEREFORE, NOT CONSIDERED AN MDR REPORTABLE EVENT. MEDICAL RECORDS FOR THIS ADMISSION WERE REQUESTED AND RECEIVED. ON (B)(6) 2010, THE PATIENT WAS ADMITTED WITH ANGINA AND ELEVATED CARDIAC ENZYMES. THE ECG CORE LAB REPORTED NO NEW ST-T ABNORMALITIES AND NO NEW Q WAVES. REPEAT ANGIOGRAPHY ON (B)(6) 2010 REVEALED PATENT GRAFTS; DIFFUSE DISEASE IN THE VEIN GRAFT TO THE DIAGONAL; AND SEVERE INSTENT RESTENOSIS IN THE PROXIMAL LCX AND IN THE DISTAL LCX. THE CORE LAB REPORTED A 17% INSTENT RESTENOSIS WITH TIMI 3 IN THE DISTAL LCX WITH THE COMMENT: "STENTED SEGMENT IN DISTAL LCX FORMS PART OF A DIFFUSELY DISEASED VESSEL; NEO-INTIMAL HYPERPLASIA MEASURES <50% BY QCA, BUT TLR PERFORMED; ALSO REMOTE TVR TO PROXIMAL AND MID RCA AND OM BRANCH". THE CORE LAB REPORTED AN 83% FINAL RESIDUAL INLESION STENOSIS IN THE PROXIMAL LCX WITH TIMI 3 FLOW WITH THE COMMENT: "TYPE 3 PATTERN OF ISR; TLR PERFORMED; ALSO REMOTE TVR OF MID AND DISTAL LCX AND OM BRANCH." ON (B)(6) 2010, REVASCULARIZATION WAS PERFORMED WITH PLACEMENT OF TWO NON-CORDIS STENTS IN THE MID LCX AND POBA IN THE OM1 BRANCH PER THE CATH REPORT. ON (B)(6) 2010, THE PATIENT REPORTED RECURRENT ANGINA. ANGIOGRAPHY REVEALED A 90% STENOSIS IN THE OM2 WITH PATENT LCX STENTS ACCORDING TO THE CATH REPORT. THE CORE LAB REPORTED A 5% INLESION STENOSIS IN THE DISTAL LCX WITH TIMI 3 FLOW AND AN 18% INLESION STENOSIS IN THE PROXIMAL LCX WITH TIMI 3 FLOW WITH THE COMMENT; "REMOTE TVR (STENTING) TO OM BRANCHING, ONE DAY FOLLOWING POBA OF SAME LESION"; HOWEVER, THE ADJUDICATION COMMITTEE CONSIDERED THIS TO BE RELATED TO THE STUDY STENT. THE PATIENT CONTINUED TO HAVE SLIGHT CHEST DISCOMFORT AND WAS DIAGNOSED WITH A PERICARDITIS ASSOCIATED WITH THE MI EVENT. THE PERICARDITIS WAS TREATED SUCCESSFULLY WITH MEDICATION. UPDATED COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT HAD MULTIPLE EVENTS OF INSTENT RESTENOSIS, THREE MIS, ANGINA, PERICARDITIS, CONGESTIVE HEART FAILURE AND ANGINA POST INDEX PROCEDURE. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING CABG IN 2007, PVD, DYSLIPIDEMIA, HYPERTENSION AND DIABETES. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA WITH POSITIVE FUNCTIONAL STUDY. THE TARGET LESIONS WERE A 90% STENOSIS IN THE DISTAL LCX AND A 95% STENOSIS IN THE OSTIUM OF THE LCX. IN (B)(6) 2010, THE INDEX PROCEDURE WAS PERFORMED. FIRST, THE DISTAL LCX LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF ONE CYPHER STENT. THE CORE LAB REPORTED 8% RESIDUAL, NO DISSECTION AND TIMI 3 FLOW. THE SECOND LESION IN THE OSTIUM OF THE LCX WAS TREATED WITH PRE-DILATION AND PLACEMENT OF ONE CYPHER STENT. THE CORE LAB REPORTED 12% RESIDUAL, NO DISSECTION AND TIMI 3 FLOW. THE POST PROCEDURE COURSE WAS UNCOMPLICATED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON DUAL ANTI-PLATELET THERAPY. IN (B)(6) 2010, THE PATIENT PRESENTED WITH RECURRENT ISCHEMIC PAIN UNRELIEVED BY NTG. THE INITIAL CK WAS 450, THE CKMB WAS 30.4 AND THE TROPONIN I WAS 4.55. THE NEXT TROPONIN WAS 6.08; CK AND CKMB WERE NOT DRAWN. THE NEXT CK WAS 427, CKMB WAS 27.7 AND THE TROPONIN WAS 5.62. THE FOLLOWING DAY, THE CK WAS 367, CKMB WAS 21.7 AND THE TROPONIN WAS 5.08. THE NEXT DAY, THE CK WAS 222, CKMB WAS 7.5 AND THE TROPONIN WAS NOT TESTED. SIX DAYS LATER, THE CK WAS 153, CKMB WAS 2.4 AND THE TROPONIN WAS 0.61. AT THE TIME OF ADMISSION, THE ECG REVEALED NSR WITH MARKED ST SEGMENT CHANGES IN THE LATERAL LEADS PER THE ER 12 LEAD REPORT. THE ECG CORE LAB REPORTED NO NEW ST-T ABNORMALITIES AND NO NEW Q-WAVES. THE SITE REPORTED A NON-Q WAVE MI. REPEAT ANGIOGRAPHY WAS DONE ON (B)(6) 2010, REVEALING A 95% RESTENOSIS IN THE OSTIAL LCX. THE CORE LAB REPORTS A 14% INSTENT RESTENOSIS OF THE DISTAL LCX STENT WITH TIMI 3 FLOW WITH THE COMMENT "PATENT STUDY STENT." FOR THE PROXIMAL LCX, THE CORE LAB REPORTED AN 85% INSTENT RESTENOSIS WITH TIMI 3 FLOW, PROVIDING THE FOLLOWING COMMENT. TYPE 1B PATTERN OF INSTENT RESTENOSIS PRESENT AT THE PROXIMAL EDGE OF THE STUDY STENT. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO PLACE A STENT IN THE OSTIAL LCX, THE STENOSIS WAS SUCCESSFULLY TREATED WITH POBA FOLLOWED BY PLACEMENT OF ONE DES STENT. THE PATIENT EXPERIENCED PERSISTENT CHEST PAIN ON A NTG DRIP. THE DISCHARGE SUMMARY NOTED A NDSR ON ECG. ON (B)(6) 2010, REPEAT ANGIOGRAPHY REVEALED AN 80% STENOSIS IN THE PROXIMAL LCX. THE CORE LAB REPORTED A 21% RESTENOSIS IN THE DISTAL LCX WITH TIMI 3 FLOW. THE CORE LAB REPORTED A 2% FINAL RESIDUAL STENOSIS IN THE PROXIMAL LCX WITH TIMI 3 FLOW AND THE FOLLOWING COMMENT. FURTHER CLINICAL EVENT 1 DAY SINCE PREVIOUS; MINOR NARROWING AT PROXIMAL EDGE OF STENT; FURTHER TVR PERFORMED. THE PATIENT UNDERWENT REPEAT REVASCULARIZATION WITH POBA IN PROXIMAL LCX. ON ADMISSION ON (B)(6) 2012, THE HEMOGLOBIN WAS 11.5 AND THE HEMATOCRIT WAS 36.6%. ON (B)(6) 2010, THE HEMOGLOBIN WAS 8.6 AND HEMATOCRIT WAS 27.7%. GI BLEED WAS RULED OUT; HOWEVER, THE PATIENT WAS DIAGNOSED WITH IRON DEFICIENCY. IV IRON WAS ADMINISTERED FOR TREATMENT. THE PATIENT WAS CLEARED FOR DISCHARGE ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT WAS AGAIN ADMITTED WITH ANGINA. THE INITIAL CK WAS 411, THE CKMB WAS 33.4 AND THE TROPONIN I WAS 2.51. ON (B)(6) 2010, THE CK WAS 585, THE CKMB WAS 34.4 AND THE TROPONIN I WAS 10.44. ON (B)(6) 2010, THE CK WAS 296, THE CKMB WAS 6.6 AND THE TROPONIN I WAS 7.87. ON (B)(6) 2010, THE CK WAS 253, THE CKMB WAS 4.6 AND THE TROPONIN I WAS NOT DRAWN. THE ECG CORE LAB REPORTED NO NEW ST-T ABNORMALITIES AND NO NEW Q WAVES. REPEAT ANGIOGRAPHY ON (B)(6) 2010 REVEALED PATENT GRAFTS; DIFFUSE DISEASE IN THE VEIN GRAFT TO THE DIAGONAL; AND SEVERE INSTENT RESTENOSIS IN THE PROXIMAL LCX AND IN THE DISTAL LCX. THE CORE LAB REPORTED A 17% INSTENT RESTENOSIS WITH TIMI 3 IN THE DISTAL LCX WITH THE COMMENT: "STENTED SEGMENT IN DISTAL LCX FORMS PART OF A DIFFUSELY DISEASED VESSEL; NEO-INTIMAL HYPERPLASIA MEASURES <50% BY QCA, BUT TLR PERFORMED; ALSO REMOTE TVR TO PROXIMAL AND MID RCA AND OM BRANCH." THE CORE LAB REPORTED AN 83% FINAL RESIDUAL INLESION STENOSIS IN THE PROXIMAL LCX WITH TIMI 3 FLOW WITH THE COMMENT: "TYPE 3 PATTERN OF ISR; TLR PERFORMED; ALSO REMOTE TVR OF MID AND DISTAL LCX AND OM BRANCH." ON (B)(6) 2010, REVASCULARIZATION WAS PERFORMED WITH PLACEMENT OF TWO STENTS IN THE MID LCX AND POBA IN THE OM1 BRANCH PER THE CATH REPORT. ON (B)(6) 2010, THE PATIENT REPORTED RECURRENT ANGINA. ANGIOGRAPHY REVEALED A 90% STENOSIS IN THE OM2 WITH PATENT LCX STENTS ACCORDING TO THE CATH REPORT. THE CORE LAB REPORTED A 5% INLESION STENOSIS IN THE DISTAL LCX WITH TIMI 3 FLOW AND AN 18% INLESION STENOSIS IN THE PROXIMAL LCX WITH TIMI 3 FLOW WITH THE COMMENT; "REMOTE TVR (STENTING) TO OM BRANCHING, ONE DAY FOLLOWING POBA OF SAME LESION." THE PATIENT CONTINUED TO HAVE SLIGHT CHEST DISCOMFORT AND WAS DIAGNOSED WITH A PERICARDITIS ASSOCIATED WITH THE MI EVENT. THE PERICARDITIS WAS TREATED SUCCESSFULLY WITH MEDICATION. IN (B)(6) 2010, THE PATIENT AGAIN PRESENTED WITH ANGINA AS WELL AS IRON DEFICIENCY ANEMIA AND EPISTAXIS. THE INITIAL CK WAS 442, THE CKMB WAS 20.3 AND THE TROPONIN I WAS 6.58. THE FOLLOW DAY, THE CK WAS 322, THE CKMB WAS 13.4 AND THE TROPONIN I WAS 4.2. THE NEXT SET THE CK AND CKMB WERE NOT DRAWN BUT THE TROPONIN I WAS 4.61. THE FINAL ENZYMES WERE: CK WAS 126, THE CKMB WAS 2.1 AND THE TROPONIN I WAS 2.93. THE ECG CORE LAB REPORTED NO NEW ST-T ABNORMALITIES AND NO NEW Q WAVES. THE INITIAL H/H WAS 9.0/28.6. THE PATIENT WAS GIVEN ONE UNIT OF PRBC AND THE FINAL H/H WAS 9.2/28.9. REPEAT ANGIOGRAPHY REVEALED AN 85% PROLIFERATIVE INSTENT RESTENOSIS WITHOUT THROMBUS AND TIMI 3 FLOW IN THE PROXIMAL LCX AND A FOCAL INSTENT RESTENOSIS IN THE DISTAL LCX INVOLVING THE DISTAL EDGE OF THE STENT WITHOUT THROMBUS AND TIMI 3 FLOW. THE SITE REPORTED ALL THREE SVG GRAFTS WERE PATENT. THE LVEF WAS REPORTED AS 45%. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER TREATMENT. THREE DAYS AFTER THE ADMISSION FOR CHEST PAIN, TMR (TRANS-MYOCARDIAL REVASCULARIZATION) WAS PERFORMED WITH ROBOTIC LASER. ACCORDING TO THE CATHETERIZATION REPORT, THE PATIENT COULD NO LONGER UNDERGO PERCUTANEOUS OR SURGICAL INTERVENTION IN THE LCX. THE STUDY STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. 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. 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. HEART FAILURE (HF) OFTEN CALLED CONGESTIVE HEART FAILURE (CHF) IS GENERALLY DEFINED AS THE INABILITY OF THE HEART TO SUPPLY SUFFICIENT BLOOD FLOW TO MEET THE NEEDS OF THE BODY. HEART FAILURE IS A GLOBAL TERM FOR THE PHYSIOLOGICAL STATE IN WHICH CARDIAC OUTPUT IS INSUFFICIENT IN MEETING THE NEEDS OF THE BODY AND LUNGS. OFTEN TERMED "CONGESTIVE HEART FAILURE" OR CHF, THIS IS MOST COMMONLY CAUSED WHEN CARDIAC OUTPUT IS LOW AND THE BODY BECOMES CONGESTED WITH FLUID. HEART FAILURE CAN CAUSE A NUMBER OF SYMPTOMS INCLUDING SHORTNESS OF BREATH, LEG SWELLING, AND EXERCISE INTOLERANCE. THE CONDITION IS DIAGNOSED WITH ECHOCARDIOGRAPHY AND BLOOD TESTS. TREATMENT COMMONLY CONSISTS OF LIFESTYLE MEASURES (SUCH AS SMOKING CESSATION, LIGHT EXERCISE INCLUDING BREATHING PROTOCOLS, DECREASED SALT INTAKE AND OTHER DIETARY CHANGES) AND MEDICATIONS. SOMETIMES IT IS TREATED WITH IMPLANTED DEVICES (PACEMAKERS OR VENTRICULAR ASSIST DEVICES) AND OCCASIONALLY A HEART TRANSPLANT. COMMON CAUSES OF HEART FAILURE INCLUDE MYOCARDIAL INFARCTION AND OTHER FORMS OF ISCHEMIC HEART DISEASE, HYPERTENSION, VALVULAR HEART DISEASE, AND CARDIOMYOPATHY. THE TERM "HEART FAILURE" IS SOMETIMES INCORRECTLY USED TO DESCRIBE OTHER CARDIAC-RELATED ILLNESSES, SUCH AS MYOCARDIAL INFARCTION (HEART ATTACK) OR CARDIAC ARREST, WHICH CAN CAUSE HEART FAILURE BUT ARE NOT EQUIVALENT TO HEART FAILURE. IT MAY ALSO OCCUR WHEN THE BODY'S REQUIREMENTS FOR OXYGEN AND NUTRIENTS ARE INCREASED AND THE DEMAND OUTSTRIPS WHAT THE HEART CAN PROVIDE, (TERMED "HIGH OUTPUT CARDIAC FAILURE"). THIS CAN OCCUR FROM SEVERE ANEMIA, GRAM NEGATIVE SEPTICAEMIA, BERIBERI (VITAMIN B1/THIAMINE DEFICIENCY), THYROTOXICOSIS, PAGET'S DISEASE, ARTERIOVENOUS FISTULAE, OR ARTERIOVENOUS MALFORMATIONS. MEDICAL PROFESSIONALS USE THE WORDS "ACUTE" TO MEAN OF RAPID ONSET AND "CHRONIC" OF LONG DURATION. CHRONIC HEART FAILURE IS THEREFORE A LONG TERM SITUATION, USUALLY WITH STABLE TREATED SYMPTOMATOLOGY. CHEST PAIN IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE CYPHER IFU AS SUCH. 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. THE NATURAL PROGRESSION OF CORONARY DISEASE AS WELL AS TARGET LESION ISSUES MAY CONTRIBUTE TO THE EXPERIENCE OF CHEST PAIN / ANGINA. PERICARDITIS, ALTHOUGH NOT SPECIFICALLY NOTED IN THE IFU, IS A KNOWN POTENTIAL ADVERSE EVENT POST STENT IMPLANTATION. PERICARDITIS IS AN INFLAMMATION OF THE PERICARDIUM (THE FIBROUS SAC SURROUNDING THE HEART). A CHARACTERISTIC CHEST PAIN IS OFTEN PRESENT. THE CAUSES OF PERICARDITIS ARE VARIED, INCLUDING VIRAL INFECTIONS OF THE PERICARDIUM, IDIOPATHIC CAUSES, UREMIC PERICARDITIS, BACTERIAL INFECTIONS OF THE PERICARDIUM AND POST-INFARCT PERICARDITIS (PERICARDITIS DUE TO HEART ATTACK). 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. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION, DYSLIPIDEMIA AND DIABETES. THIS IS ONE OF TWO (2) REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00293 AND 3003742446-2010-00294.
THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING STENT IMPLANTATION AND ARE OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S AGGRESSIVE PROGRESSION OF CORONARY ARTERY DISEASE, RISK FACTORS PRESENT IN THE MEDICAL HISTORY (DIABETES) AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THESE EVENTS. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. THIS IS ONE OF TWO (2) REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00293 AND 3003742446-2010-00294.
DURING THE DECOMPRESSION STATE IN THE CHAMBER THE EXHALATION PHASE ON THE HBO VENTILATOR STUCK CAUSING IT TO STAY CLOSED. THIS IN TURN CAUSED THE VENT TO NOT CYCLE OVER THE EXHALATION RESULTING IN PROLONGED ELEVATED AIRWAY PRESSURES. PERFUSIONIST REPORTED HE IS NOT SURE WHICH PATIENT USED WITH WHICH VENT. TREATMENT DATE: (B)(6) 2010. TREATED FOR CARBON MONOXIDE POISONING. NO CARDIAC EMBARRASSMENT (SATURATION LEVELS DID NOT DROP OFF). THE PROBLEM WAS CAUGHT QUICKLY AND VENTILATOR WAS CUT-OFF AND THEN WAS MANUALLY VENTILATED. THE VENTILATOR WAS IMMEDIATELY PULLED OUT OF SERVICE.
ADDITIONAL INFORMATION WAS RECEIVED VIA THE CEC ADJUDICATION COMMITTEE MINUTES ON 8/2/2011. AT THE TIME OF THE MYOCARDIAL INFARCTION (MI) ON (B)(6) 2010, THE PATIENT HAD 64% FOCAL IN-STENT RESTENOSIS IN THE DISTAL CIRCUMFLEX. THE MI AND RESTENOSIS WERE PREVIOUSLY REPORTED FOR THE PROXIMAL CIRCUMFLEX STENT (SEE REPORT 3003742446-2010-00293), AS THIS WAS THE ONLY AREA OF RESTENOSIS REPORTED IN THE CRF. SINCE THERE WAS RESTENOSIS IN THE DISTAL CIRCUMFLEX, MI AND RESTENOSIS WILL BE CAPTURED FOR THIS DISTAL CIRCUMFLEX STENT AS WELL.
PER THE (B)(6) STUDY: THIS (B)(6) FEMALE PATIENT WITH A HISTORY OF CAD, PREVIOUS CORONARY ARTERY BYPASS GRAFTING ((B)(6) 2007), HYPERLIPIDEMIA, HYPERTENSION, PVD/CLAUDICATION, AND DIABETES MELLITUS II WAS ADMITTED DUE TO STABLE ANGINA AND POSITIVE CARDIAC STRESS TEST. PREPROCEDURE LABS REVEALED CK SLIGHTLY ELEVATED TO 173 (ULN = 135). CK-MB WAS WITHIN NORMAL LIMITS. ANGIOGRAPHY REVEALED LESIONS IN THE PROXIMAL AND MID CIRCUMFLEX ARTERY. THE LESION IN THE MID LCX WAS DESCRIBED AS A DE NOVO, 8MM, 95% B1-TYPE STENOSIS. THE TARGET WAS PREDILATED WITH A 2.5 X 12MM NON-CORDIS PTCA BALLOON INFLATED TO 8 ATMS. A 2.5 X 13MM CYPHER STENT WAS DEPLOYED TO 12 ATMS WITHOUT COMPLICATION. THE LESION IN THE PROXIMAL LCX WAS DESCRIBED AS A DE NOVO, 8MM, 95% B1-TYPE STENOSIS. THE TARGET WAS PREDILATED WITH A 2.5 X 12MM NON-CORDIS PTCA BALLOON INFLATED TO 8 ATMS. A 2.5 X 13MM CYPHER STENT WAS DEPLOYED TO 16 ATMS WITHOUT COMPLICATION. THE FOLLOWING MORNING, CK HAD DECREASED TO 140. THE PATIENT WAS DISCHARGED IN STABLE CONDITION WITH ORDERS FOR DAILY ASPIRIN AND PLAVIX. TWO MONTHS POST INDEX PROCEDURE, THIS PATIENT PRESENTED WITH RECURRENT ISCHEMIC SYMPTOMS LASTING 20 MINUTES OR MORE THAT DID NOT RESPOND TO NITROGLYCERINE. THE PATIENT WAS RULED IN FOR NON Q-WAVE MI. ANGIOGRAPHY REVEALED A 95% RESTENOSIS WITHIN THE CYPHER STENT IN THE PROXIMAL LCX. THIS WAS TREATED WITH PTCA AND PLACEMENT OF AN ADDITIONAL DES. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.
FIVE MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH MI (NSTEMI). CARDIAC ENZYMES WERE ELEVATED WITH CK 411 (135 ULN), AND CK-MB 33.4 (5 ULN). ANGIOGRAPHY REVEALED RESTENOSIS OF BOTH CYPHER STENTS PLACED IN THE PROXIMAL AND DISTAL LCX, AS WELL AS NEW LESIONS IN THE OM 1 AND OM 2. THE DISTAL LCX WAS TREATED WITH PLACEMENT OF AN ADDITIONAL DRUG-ELUTING STENT. THE PROXIMAL LCX AND OM 1 WERE TREATED WITH BALLOON ANGIOPLASTY ONLY. THE OM2 WAS TREATED WITH PLACEMENT OF A DRUG-ELUTING STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | 15127440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| L| R | 2.5 X 13MM CYPHER STENT |