BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 974268 · Received January 16, 2006

    Report

    Report Number
    3003742446-2006-01111
    Event Type
    Death
    Date Received
    January 16, 2006
    Date of Event
    November 2, 2005
    Report Date
    January 16, 2006
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFO WAS PROVIDED BY THE SALES REP: THIS PT WITH AN UNKNOWN PAST MEDICAL HISTORY WAS ADMITTED FOR ELECTIVE CARDIAC CATHETERIZATION. THE TARGET LESIONS WERE IDENTIFIED AS THE RIGHT CORONARY ARTERY (RCA), CIRCUMFLEX (CX) AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD). LESION CHARACTERISTICS NOT SUPPLIED. TREATMENT WAS AS FOLLOWS: LESION 1 - RCA. JR4 6 FR, 0.014 PT GRAPHIX. IVUS WAS PERFORMED. THE LUMINAL AREA WAS 3.9MM SQUARED. THERE WAS 77% STENOSIS. PRIMARY STENTING WAS PERFORMED WITH A (LOT 40905515) AT 16 ATMS FOR 30 SECONDS. POST-DILATATION WAS CONDUCTED WITH A POWERSAIL 4.0 X 13MM RX AT 16 ATMS FOR 25 SECONDS. FOLLOW-UP IVUS NOTED FULL STENT APPOSITION WITH AN MLD OF 3.9MM. LESION 2 - CX. VODA 3.5 6 FR, -.014 PT GRAPHIX IVUS WAS PERFORMED. THE LUMINAL AREA WAS 3.1MM SQUARED WITH AN MLD OF 1.7MM. THERE WAS 75% STENOSIS. PRIMARY STENTING WAS PERFORMED WITH A (LOT 40905881) AT 14 ATMS FOR 35 SECONDS. POST-DILATATION WAS CONDUCTED WITH A POWERSAIL 3.5 X 15MM RX AT 14 ATMS FOR 25 SECONDS. FOLLOW-UP IVUS CONFIRMED FULL STENT APPOSITION WITH A MLD OF 3.4MM. LESION 3 - LAD. THIS LESION WAS NOTED TO BE A BIFURCATING LESION (LAD/DIAGONAL). JL4 6FR, 0.014 PT GRAPHIX IVUS WAS PERFORMED. THE LUMINAL AREA WAS 2.6MM SQUARED WITH A MLD OF 1.5MM. THERE WAS 77% STENOSIS. THE LESION WAS PRE-DILATED WITH A 3.0 X 10MM RX CUTTING BALLOON AT 10 ATMS FOR 60 SECONDS. A (LOT A1005289) WAS DEPLOYED AT 16 ATMS FOR 30 SECONDS. POST-DILATATION WAS CONDUCTED WITH A 3.0 X 23MM POWERSAIL AT 16 ATMS FOR 15 SECONDS. FOLLOW-UP IVUS NOTED GOOD WALL APPOSITION WITH 1:1 STENT TO VESSEL SIZING. LESION 4 - DIAGONAL. THERE WAS A PLAQUE SHIFT THAT OCCURRED FROM THE LAD STENT INTO THE DIAGONAL. THE MD PULLED BACK THE 0.014 PT GRAPHIX AND RE-POSITIONED IT INTO THE DIAGONAL BRANCH. THIS WAS TREATED WITH A 2.5 X 8MM RX QUANTUM MAVERICK BALLOON AT 14 ATMS FOR 30 SECONDS. MEDICATIONS ADMINISTERED DURING THE CASE INCLUDED HEPARIN AND INTEGRILIN (DOSAGES UNKNOWN). HOWEVER, THE INTEGRILIN WAS CONTINUED FOR 12 HOURS POST-PROCEDURE. POST-PROCEDURE ANTIPLATELET THERAPY INCLUDED ASPIRIN AND PLAVIX (DOSAGES UNKNOWN). TWO DAYS LATER, THE PATIENT PRESENTED TO A DIFFERENT FACILITY WITH A SAT. CORONARY ANGIOGRAPHY REVEALED A THROMBUS IN THE LAD. THIS WAS TREATED WITH ANGIOJET AND PTCA (NO DETAILS CURRENTLY AVAILABLE). HOWEVER, THE PT IS SAID TO HAVE EXPIRED. IT IS NOT CLEAR IF THE DATE OF DEATH WAS THE SAME DAY AS SAT EVENT OR WITHIN THE NEXT TWO DAYS. THE FOLLOWING IS A SUMMARY OF THE CARDIAC CATHETERIZATION REPORT OF THE INDEX PROCEDURE: INDICATION FOR PROCEDURE: NEW ONSET CHF SECONDARY TO SEVERE DILATED CARDIOMYOPATHY. DOPPLER ECHO REVEALED SEGMENTAL WALL MOTION ABNORMALITIES. QUESTIONABLE ISCHEMIC CARDIOMYOPATHY. ANGIOGRAPHY: LEFT CORONARY ARTERY (JUDKINS #4 LEFT CATHETER): NORMAL LEFT MAIN. FIFTY PERCENT PROXIMAL OBSTRUCTION OF THE CIRCUMFLEX (CX). SEVENTY FIVE PERCENT OBSTRUCTION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) SPANNING THE ORIGIN OF THE FIRST DIAGONAL (D1). RIGHT CORONARY ARTERY (RCA) (JUDKINS #4 RIGHT CATHETER): PROXIMAL PORTION HAD AN OBVIOUS DENSITY CHANGE WITH HEAVY CALCIFICATION. OCCLUSIVE DISEASE SUSPECTED. LEFT VENTRICULOGRAPHY: DILATED LEFT VENTRICLE. DIFFUSE HYPOKINESIS. EF 30%. MODERATE 2+/4+ MITRAL REGURGITATION. INTERVENTION: BOLUS OF HEPARIN AND AN INTEGRILIN INFUSION WERE ADMINISTERED. RCA - ENGAGED WITH A JUDKINS #4 RIGHT 6FR GUIDE. A 0.014 PT-GRAPHIX GW WAS PLACED IN THE DISTAL PORTION. IVUS WAS CONDUCTED. MINIMAL LUMINAL AREA WAS 3.9 MM SQUARED WITH 77% STENOSIS NOTED. A CYPHER 3.5 X 18MM STENT WAS DEPLOYED AT 16 ATMS FOR 30 SECONDS. THE STENT WAS "UP-SIZED" WITH A 4.0 X 13MM NONCOMPLIANT POWERSAIL MONORAIL BALLOON AT 16 ATMS FOR 25 SECONDS IVUS WAS CONDUCTED AND MINIMAL LUMINAL DIAMETER WAS 3.9MM WITH FULL STENT APPOSITION NOTED. THE MAIN CORONARY ARTERY WAS ENGAGED WITH A 6 FR 3.5 LEFT VODA GUIDE. THE 0./014 PT-GRAPHIX GW WAS PLACED IN THE DISTAL PORTION OF THE CIRCUMFLEX. IVUS CONFIRMED THE SITE OF GREATEST OBSTRUCTION. THE MINIMAL LUMINAL AREA WAS 3.1 MM SQUARED WITH A MINIMAL LUMINAL DIAMETER OF 1.7MM AND 75% STENOSIS. A CYPHER 3.5 X 18MM STENT WAS DEPLOYED AT 14 ATMS FOR 35 SECONDS. POST-DILATATION WAS CONDUCTED WITH A 3.5 X 15MM NONCOMPLIANT POWERSAIL MONORAIL BALLOON AT 14 ATMS FOR 25 SECONDS. THERE WAS NO RESIDUAL OBSTRUCTION AND NO EVIDENCE OF DISSECTION WITH NORMAL DISTAL FLOW. IVUS DEMONSTRATED MINIMAL LUMINAL DIAMETER OF 3.4MM WITH FULL STENT APPOSITION. THE LEFT MAIN CORONARY ARTERY WAS ENGAGED WITH A JUDKINS #4 LEFT 6FR GUIDE. THE 0.014 PT-GRAPHIX GW WAS PLACED IN THE APICAL PORTION OF THE LAD. IVUS NOTED THE GREATEST OBSTRUCTION TO BE ADJACENT TO THE PRINCIPAL DIAGONAL VESSEL WITH SEVER OCCLUSIVE DISEASE. THE MINIMAL LUMINAL AREA WAS 2.6MM SQUARED WITH A MINIMAL LUMINAL DIAMETER OF 1.5MM AND 75% STENOSIS. MULTIPLE DILATATIONS WERE MADE USING A 3.0 X 10MM MONORAIL SCIMED FLEXTONE CUTTING BALLOON. THE MAX INFLATION PRESSURE WAS 10 ATMS FOR AS LONG AS 60 SECONDS. LONGER INFLATIONS WERE NOT TOLERATED DUE TO SEVER HYPOTENSION. FOLLOWING PRE-DILATATION, A CYPHER 3.0 X 28MM STENT WAS DEPLOYED AT 16 ATMS FOR 30 SECONDS. THE STENT WAS POST-DILATED WITH A 3.0 X 23MM NONCOMPLIANT POWERSAIL MONORAIL BALLOON AT 16 ATMS FOR 15 SECONDS. THERE WAS NO RESIDUAL OBSTRUCTION. HOWEVER, THERE HAD BEEN SEVERE PLAQUE SHIFTING INTO THE ORIGIN OF THE PRINCIPAL D1 WITH A RESULTANT 95% OBSTRUCTION. THE LESION WAS CROSSED WITH A 0.014 PT-GRAPHIX. THE LESION WAS DILATED WITH A QUANTUM MAVERICK MONORAIL BALLOON AT 14 ATMS FOR 30 SECONDS. THERE WAS NO RESIDUAL OBSTRUCTION AND DISTAL FLOW WAS NORMAL. THE PATIENT WAS FREE OF CHEST PAIN AND HEMODYNAMICALLY STABLE. ADDITIONAL PATIENT AND ADVERSE EVENT SPECIFIC INFORMATION, INCLUDING CAUSE OF DEATH PER DEATH CERTIFICATE AND AUTOPSY REPORT (IF APPLICABLE) HAS BEEN REQUESTED BUT HAVE NOT BEEN FORTHCOMING. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ALTHOUGH THE EVENT WAS REPORTED AS AN SAT/DEATH ASSOCIATED WITH ONLY ONE OF THE THREE IMPLANTED DEVICES, IT HAS BEEN DETERMINED, THAT AS NO EXACT CAUSE OF DEATH IS AVAILABLE, THE OTHER TWO DEVICES WILL BE INCLUDED AS POSSIBLY RELATED TO THE DEATH AND ARE REPORTED UNDER SEPARATE MEDWATCH. HOWEVER, THERE WAS NO ANGIOGRAPHIC EVIDENCE TO SUGGEST A PROBLEM WITH THESE DEVICES. PLEASE REFER TO MFR REPORT # 3003742446-2005-01891 & #3003742446-2006-11112.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS PROVIDED BY THE SALES REP: TWO DAYS FOLLOWING PERCUTANEOUS CORONARY INTERVENTION WITH STENT PLACEMENT, THIS PT PRESENTED WITH A SUB-ACUTE THROMBOSIS (SAT). REPEAT ANGIOGRAPHY REVEALED THROMBUS IN THE CYPHER STENTED LEFT ANTERIOR DESCENDING ARTERY (LAD). THIS IS REPORTED TO HAVE BEEN TREATED WITH ANGIOJET AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE PT'S DEATH WAS REPORTED TO THE SALES REP 2 DAYS LATER. EXACT CAUSE OR DATE OF DEATH REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS LLC (PR) NA 40905515

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| L