BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2060649 · Received April 18, 2011

    Report

    Report Number
    3003742446-2011-00185
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    February 17, 2010
    Report Date
    March 24, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY FIVE HOURS LATER, THE PATIENT EXPERIENCED THE ABRUPT ONSET OF CHEST PAIN AND ST-SEGMENT ELEVATION ON EKG IN THE INFERIOR LEADS CONSISTENT WITH ACUTE MYOCARDIAL INFARCTION AND WAS BROUGHT EMERGENTLY TO THE CARDIAC CATHETERIZATION LAB FOR ANGIOGRAPHY. DUE TO HEMATOMA FORMATION AND SOME OOZING AROUND THE 6F SHEATH (BRAND UNKNOWN), THE SHEATH WAS CHANGED TO AN 8F NON-KINKING SHEATH. ANGIOGRAPHY REVEALED A FILLING DEFECT FROM JUST DISTAL TO THE DISTAL EDGE OF THE STENT WITH SUBSEQUENT TOTAL OCCLUSION OF THE DISTAL VESSEL. THIS HAD THE APPEARANCE OF EITHER THROMBUS OR SPIRAL DISSECTION. THE PATIENT WAS TREATED WITH A 2.5 X 15MM XIENCE STENT, FOLLOWED BY TWO SEPARATE 3.0 X 15MM XIENCE STENTS, AND TWO SEPARATE 3.0 X 18MM XIENCE STENTS PLACED DISTALLY TO PROXIMALLY IN OVERLAPPING FASHION, OVERLAPPING THE PREVIOUSLY PLACED CYPHER STENT. IN ADDITION, THE PATIENT WAS TREATED WITH INTRAVENOUS HEPARIN AND AN INTEGRILIN DRIP. ANGIOGRAPHIC RESULTS WERE EXCELLENT WITH TIMI 3 FLOW INTO THE DISTAL VESSEL AND NO EVIDENCE OF A THROMBOTIC OR EMBOLIC EVENT IN THE DISTAL VESSEL. THE PATIENT WAS RETURNED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. APPROXIMATELY FIVE WEEKS LATER, THE PATIENT WAS SEEN IN THE PHYSICIAN'S OFFICE, AND IT WAS NOTED THAT THE PATIENT WAS STATUS POST STENT OF THE CIRCUMFLEX ARTERY WITH INFEROBASAL HYPOKINESIS WITH EJECTION FRACTION 45% ON ECHOCARDIOGRAM. THE PATIENT WAS RESTARTED ON COUMADIN. CONCOMITANT MEDICATIONS INCLUDED AMBIEN, FUROSEMIDE, LISINOPRIL, XANAX, HEPARIN, PLAVIX. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED 4/12/2011 INDICATED THAT THE SHEATH USED FOR THE PROCEDURE WAS A 6F CORDIS SHEATH. NO TREATMENT FOR THE GROIN HEMATOMA WAS REPORTED AND NO HEMATOMA WAS VISIBLE THE FOLLOWING DAY. COMPLAINT CONCLUSION: INFORMATION RECEIVED FROM AN ACCOUNT INDICATED THAT A PATIENT EXPERIENCED A MYOCARDIAL INFARCTION, POSSIBLE STENT THROMBOSIS AND A DISSECTION AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR SHORTNESS OF BREATH, ANKLE EDEMA, ATRIAL FIBRILLATION FOR WHICH THE PATIENT WAS NOT CURRENTLY ON COUMADIN. THE ADMITTING DIAGNOSIS WAS DYSPNEA ON EXERTION, ATRIAL FIBRILLATION AND HYPERTENSION. A RIGHT AND LEFT HEART CATH WAS PERFORMED, REVEALING A TOTALLY OCCLUDED RIGHT CORONARY ARTERY WITH COLLATERAL CIRCULATION, NO DISEASE IN THE LEFT MAIN ARTERY, A 30-40% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, A TUBULAR 50-60% STENOSIS AT THE JUNCTION OF THE MID TO DISTAL LAD AND A 80-90% STENOSIS IN THE PROXIMAL CIRCUMFLEX ARTERY (CFX). THE PROXIMAL CFX WAS TREATED WITH PRE-DILATION FOLLOWED BY THE IMPLANT OF A 3.0MM X 18MM CYPHER STENT AT 12 ATMS. "THERE WAS EXCELLENT ANGIOGRAPHIC RESULT WITH NO EVIDENCE OF RESIDUAL STENOSIS OR DISTAL EMBOLIZATION." A 6 F CORDIS SHEATH WAS USED DURING THE PROCEDURE AND SUTURED IN PLACE WHEN THE PROCEDURE WAS COMPLETED. MEDICATIONS GIVEN FOR THE PROCEDURE WERE 600MG OF PLAVIX AT COMPLETION AND 9000 UNITS OF HEPARIN DURING THE PROCEDURE WITH A MEASURED ACT OF 147. APPROXIMATELY FIVE HOURS LATER, THE PATIENT WAS BROUGHT EMERGENTLY TO THE CATH LAB FOR ABRUPT ONSET OF CHEST PAIN WITH ST SEGMENT ELEVATION CONSISTENT WITH AN ACUTE MI. ANGIOGRAPHY WAS PERFORMED AND REVEALED A FILLING DEFECT FROM JUST DISTAL TO THE DISTAL EDGE OF THE STENT WITH SUBSEQUENT TOTAL OCCLUSION OF THE DISTAL VESSEL. THIS HAD THE APPEARANCE OF EITHER THROMBUS OR A SPIRAL DISSECTION. THE EVENT WAS TREATED WITH THE IMPLANT OF 2.5MM X 15MM XIENCE STENT IN THE DISTAL CFX. "SUBSEQUENTLY 2 SEPARATE 3.0X15 XIENCE STENTS, A 3.0X18 XIENCE STENT AND 2 SEPARATE 3.0X18MM XIENCE STENT WERE DEPLOYED MORE PROXIMALLY, OVERLAPPING THE PREVIOUSLY PLACED CYPHER STENT. THERE WAS EXCELLENT ANGIOGRAPHIC RESULT WITH TIMI-3 FLOW INTO THE DISTAL VESSEL AND NO EVIDENCE OF THROMBOTIC OR EMBOLIC EVENT IN THE DISTAL VESSELS." DUE TO HEMATOMA FORMATION AND SOME OOZING AROUND THE 6F SHEATH, THE SHEATH WAS EXCHANGED FOR AN 8F SHEATH. THE PATIENT WAS ALSO STARTED ON HEPARIN AND INTEGRELIN. THE DEVICE WAS IMPLANTED AND NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE CYPHER STENT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION, STENT THROMBOSIS AND DISSECTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE MI IS MOST LIKELY RELATED TO THE ABRUPT CLOSURE OF THE VESSEL EITHER FROM THROMBOSIS OR DISSECTION. ACUTE THROMBOTIC EVENTS ARE USUALLY RELATED TO AN UNTHERAPEUTIC LEVEL OF ANTICOAGULATION DURING AND AFTER THE PROCEDURE. THE ACC RECOMMENDS AN ACT LEVEL OF 300 AS THERAPEUTIC. DISSECTIONS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THE IFU CAUTIONS THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT ASIDE FROM THE INHERENT RISK OF THE PROCEDURE, PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS NEEDED.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED STENT THROMBUS OR SPIRAL DISSECTION AND MYOCARDIAL INFARCTION APPROXIMATELY FIVE HOURS AFTER CYPHER STENT PLACEMENT. THE PATIENT HAD BEEN ADMITTED DUE TO DYSPNEA ON EXERTION, ATRIAL FIBRILLATION, HYPERTENSION AND CORONARY ARTERY DISEASE AND HAD BEEN INSTRUCTED TO STOP TAKING COUMADIN PRIOR TO THE PROCEDURE ON AN UNKNOWN DATE. ANGIOGRAPHY REVEALED AN OBTUSE MARGINAL BRANCH THAT WAS TOTALLY OCCLUDED AND 80 TO 90% PROXIMAL CIRCUMFLEX STENOSIS. THE PROXIMAL CIRCUMFLEX LESION WAS PRE-DILATED WITH A 2.5 X 15MM VOYAGER BALLOON AND A 3.0 X 18MM CYPHER DRUG-ELUTING STENT WAS DEPLOYED AT 12 ATM. THERE WERE EXCELLENT ANGIOGRAPHIC RESULTS WITH NO EVIDENCE OF RESIDUAL STENOSIS OR DISTAL EMBOLIZATION. THE PATIENT HAD RECEIVED 9,000 UNITS IV BOLUS OF HEPARIN AND A LOADING DOSE OF 600MG PLAVIX. ACT WAS REPORTED TO BE 147 SECONDS. THE PATIENT WAS RETURNED TO HIS ROOM IN SATISFACTORY CONDITION.

    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 15069542

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R