BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2140615 · Received June 27, 2011

    Report

    Report Number
    3003742446-2011-00334
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    April 5, 2010
    Report Date
    August 18, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMMITTEE AGREES WITH PROTOCOL-DEFINED NON-Q-WAVE MI (TARGET VESSEL) AND ARC [PERI-PROCEDURAL PCI], RELATED TO PROCEDURE AND DEVICE. THIS WAS NOT INITIALLY REPORTED AS AN ADVERSE EVENT. THE PATIENT WAS ADMITTED ON 4/3 WITH A STEMI, INTERVENTION WAS PERFORMED ON THE RCA AT THE TIME AND TWO DAYS LATER A STUDY STENT WAS LACED IN THE PROXIMAL LAD. THE CKMB WAS STILL ELEVATED AT THAT TIME, THE TROPONIN I WAS NOT DRAWN. POST TREATMENT THE CARDIAC ENZYMES ROSE AGAIN AND THIS HAS BEEN ADJUDICATED TO BE A PERI-PROCEDURAL MI. INFORMATION RECEIVED FROM THE CEC MINUTES OF THE CYPRESS STUDY INDICATED THAT A PATIENT EXPERIENCED A PERI-PROCEDURAL MYOCARDIAL INFARCTION AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT ALSO EXPERIENCED RE-OCCLUSION OF ANOTHER STENT. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, PREVIOUS PCI TO THE RIGHT CORONARY ARTERY ON (B)(6) 2010, HISTORY OF CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION (B)(6) 2010 STEMI, SMOKING AND ASTHMA. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE TARGET LESION WAS THE DISTAL PORTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS DE NOVO AND 90% STENOSED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.5MM X 28MM CYPHER STENT AT 16ATMS. THE STENT WAS POST-DILATED PER ROUTINE PROTOCOL AND THE REPORTED RESIDUA STENOSIS WAS 0%. THE CARDIAC ENZYMES WERE ELEVATED POST-PROCEDURE; THIS EVENT WAS ADJUDICATED TO BE A PERI-PROCEDURAL MYOCARDIAL INFARCTION. TWO WEEKS LATER A PLANNED STAGED PROCEDURE WAS PERFORMED AND THE PATIENT RECEIVED TWO CYPHER STENTS IN THE PROXIMAL TO DISTAL CIRCUMFLEX. THE EMAIL RECEIVED FROM THE (B)(4) STUDY INDICATED THAT APPROXIMATELY FOUR MONTHS LATER THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN. A REVASCULARIZATION WAS PERFORMED AND THE PATIENT REQUIRED A CABG OF THE LEFT MAIN. THE IMPLANTED CYPHER STENTS IN THE PROXIMAL AND MID RCA WERE PATENT. THE CYPHER STENT IN THE DISTAL CIRCUMFLEX HAD 30% OCCLUSION. NO INTERVENTION WAS PERFORMED ON THE CYPHER STENT IN THE DISTAL CFX. THERE WAS NO DISEASE DISTAL TO THE LEFT MAIN. THE DISEASE THAT REQUIRED BYPASS SURGERY WAS ONLY IN THE LEFT MAIN. THE DISEASE IN THE LEFT MAIN WAS NOT WITHIN 5MM OF THE CYPHER STENT IN THE PROXIMAL LAD. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. ELEVATED CARDIAC ENZYMES ARE A COMMON RESULT OF IMPLANTING CORONARY ARTERY STENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, WHICH LEADS TO DAMAGED HEART CELLS AND THE RELEASE OF CARDIAC BIOMARKER ENZYMES INTO THE SYSTEMIC BLOODSTREAM. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT. REOCCLUSION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENT PLACEMENT. BASED ON THE AVAILABLE INFORMATION, THERE ARE PATIENT AND VESSEL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE GENDER OF THE PATIENT IS MALE. THE GENDER OF THE PATIENT HAD BEEN INADVERTENTLY REPORTED AS A FEMALE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CYPRESS STUDY. APPROXIMATELY 39 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD A MODERATE NON-Q-WAVE MYOCARDIAL INFARCTION (MI). ELEVATED ENZYMES WERE NOTED. THE EVENT WAS MEDICALLY MANAGED AND RESOLVED WITHOUT SEQUELAE; CATHETERIZATION WITH NO INTERVENTION. THE EVENT DID NOT REQUIRE REVASCULARIZATION. AS THE GRAFTS WERE PATENT, NO FURTHER INTERVENTION IS REQUIRED. THE EVENT WAS DEEMED UNRELATED TO THE INDEX PROCEDURE, CYPHER STENT, AND STUDY DRUG. THERE WAS RECURRENT ISCHEMIC SYMPTOMS LASTING 10 MINUTES OR MORE. THERE WAS NO RECURRENT ISCHEMIC PAIN X 20 MINUTES, UNRELIEVED BY NTG. THERE WAS NO ST ELEVATION, DEPRESSION, OR BUNDLE BRANCH BLOCK (BBB). THERE WAS NO EVIDENCE OF STENT THROMBOSIS. THERE WAS 100% RESTENOSIS IN THE OSTIAL LAD WITHIN 5MM OF STENT IMPLANTED IN THE PROXIMAL LAD AT THE TIME OF THE INDEX PROCEDURE. NO INTERVENTION WAS PROVIDED TO TREAT THE RESTENOSIS. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE THREE CYPHER STENTS IMPLANTED IN THE PROXIMAL TO DISTAL CIRCUMFLEX AT THE TIME OF THE STAGED PROCEDURE ARE PATENT. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 3003742446-2011-00334, 3003742446-2014-00013, 3003742446-2014-00014 & 3003742446-2014-00015. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT. CONCOMITANT MEDICATIONS: INTEGRILIN AND ANGIOMAX WERE GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, PRASUGREL, LOPRESSOR, VASOTEC, ZOCOR, AND AN UNKNOWN HORMONE REPLACEMENT FOR HYPOTHYROIDISM. POST-PROCEDURE MEDICATIONS INCLUDED THIENOPYRIDINE, KDUR, FUROSEMIDE, LISINOPRIL, COREG, RANEXA, LIPITOR, AND PLAVIX.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 3003742446-2011-00334, 3003742446-2014-00013, 3003742446-2014-00014 & 3003742446-2014-00015. COMPLAINT CONCLUSION: AS REPORTED BY THE CYPRESS STUDY, A (B)(6) MALE PATIENT HAD A MODERATE NON-Q-WAVE MYOCARDIAL INFARCTION (MI) APPROXIMATELY 39 MONTHS FOLLOWING THE INDEX PROCEDURE. THERE WAS RECURRENT ISCHEMIC SYMPTOMS LASTING 10 MINUTES OR MORE. THERE WAS NO RECURRENT ISCHEMIC PAIN X 20 MINUTES, UNRELIEVED BY NTG. THERE WAS NO ST ELEVATION, DEPRESSION, OR BBB. THE EVENT WAS MEDICALLY MANAGED AND RESOLVED WITHOUT SEQUELAE. THE EVENT WAS DEEMED UNRELATED TO THE INDEX PROCEDURE, CYPHER STENT, AND STUDY DRUG. THERE WAS NO EVIDENCE OF STENT THROMBOSIS. THE EVENT DID NOT REQUIRE REVASCULARIZATION. THE PATIENT HAD 100% DISTAL RIGHT CORONARY ARTERY (RCA) STENOSIS AND 100% OSTIAL LEFT ANTERIOR DESCENDING (LAD) ARTERY STENOSIS. THERE WAS 100% RESTENOSIS IN THE OSTIAL LAD WITHIN 5MM OF THE STENT IMPLANTED IN THE PROXIMAL LAD AT THE TIME OF THE INDEX PROCEDURE. NO INTERVENTION WAS PERFORMED TO TREAT THE STENOSIS. MEDICAL THERAPY WAS PROVIDED TO THE PATIENT FOR THE MI; CATHETERIZATION WITH NO INTERVENTION. ELEVATED CARDIAC ENZYMES WERE NOTED. AS THE GRAFTS WERE PATENT, NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE PATIENT HAS A MEDICAL HISTORY CONSISTING OF ANGINA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, ACUTE CORONARY SYNDROME, UNSTABLE ANGINA PECTORIS, MYOCARDIAL INFARCTION 4-3-2010 STEMI, SYMPTOM ONSET LESS THAN 14 DAYS PRIOR TO ENROLLMENT, HISTORY OF SMOKING (WITHIN 30 DAYS), ASTHMA, AND ON (B)(6) 2010 CABG SURGERY WITH GRAFTING OF THE LIMA TO THE LAD AND RIMA TO THE CX. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AS THE STENT REMAINS IMPLANTED. 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. REVIEW OF LOT 15096316 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TYPE OF TREATMENT OF THE DISEASE PROCESS AND IT IS NOT A PREVENTION OR CURE OF THE PROGRESSION OF ATHEROSCLEROTIC ARTERY DISEASE. A MYOCARDIAL INFARCTION (MI) RESULTS WHEN A CORONARY VESSEL BECOMES COMPLETELY OBSTRUCTED AND BLOCKS THE VESSEL FROM SUPPLYING BLOOD TO THE HEART MUSCLE, CAUSING THE HEART MUSCLE TO DIE. A Q-WAVE MYOCARDIAL INFARCTION IS CHARACTERIZED BY A DEVELOPMENT OF ABNORMAL Q WAVES ON AN ECG. A NON-Q-WAVE MYOCARDIAL INFARCTION IS CHARACTERIZED BY A LACK OF DEVELOPMENT OF ABNORMAL Q WAVES AND BY THE APPEARANCE OF REVERSIBLE ST-T-WAVE CHANGES WITH ST DEPRESSION. AN MI IS A KNOWN POTENTIAL ADVERSE EVENT RELATED TO HAVING A CORONARY STENT IMPLANTED. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY A SIDE BRANCH, CAUSING AN MI. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PROGRESSION OF THE PATIENTS¿ CORONARY ARTERY DISEASE (EXTENSIVE MEDICAL HISTORY) CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INFORMATION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    THE (B)(6) FEMALE PATIENT RECEIVED A 2.50 X 28MM CYPHER STENT IN THE PROXIMAL LAD. TWO WEEKS LATER, A PLANNED STAGED PROCEDURE WAS PERFORMED AND THE PATIENT RECEIVED THREE CYPHER STENTS IN THE PROXIMAL TO DISTAL CIRCUMFLEX. THE EMAIL RECEIVED FROM THE CYPRESS INDICATED THAT APPROXIMATELY FOUR MONTHS LATER, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN. A REVASCULARIZATION WAS PERFORMED AND THE PATIENT REQUIRED A CABG OF THE LEFT MAIN. THE IMPLANTED CYPHER STENTS IN THE PROXIMAL AND MID RCA WERE PATENT. THE CYPHER STENT IN THE DISTAL CIRCUMFLEX HAD 30% OCCLUSION. NO INTERVENTION WAS PERFORMED ON THE CYPHER STENT IN THE DISTAL CFX. THERE WAS NO DISEASE DISTAL TO THE LEFT MAIN. THE DISEASE THAT REQUIRED BYPASS SURGERY WAS ONLY IN THE LEFT MAIN. THE DISEASE IN THE LEFT MAIN WAS NOT WITHIN 5MM OF THE CYPHER STENT IN THE PROXIMAL LAD. THE CEC MINUTES OF 5/18 WERE RECEIVED ON (B)(6) AND REVIEWED, ADJUDICATION STATUS-FINAL REPORT. THE COMMITTEE AGREES WITH PROTOCOL-DEFINED NON-Q-WAVE MI (TARGET VESSEL) AND ARC [PERI-PROCEDURAL PCI], RELATED TO PROCEDURE AND DEVICE ON (B)(6) 2010. THIS WAS NOT INITIALLY REPORTED AS AN ADVERSE EVENT. THE PATIENT WAS ADMITTED ON (B)(6) 2010 WITH A STEMI, INTERVENTION WAS PERFORMED ON THE RCA AT THE TIME AND TWO DAYS LATER A STUDY STENT WAS LACED IN THE PROXIMAL LAD. THE CKMB WAS STILL ELEVATED AT THAT TIME, THE TROPONIN I WAS NOT DRAWN. POST TREATMENT, THE CARDIAC ENZYMES ROSE AGAIN AND THIS HAS BEEN ADJUDICATED TO BE A PERI-PROCEDURAL MI.

    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) NA 15096316

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R ASPIRIN