BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1964148 · Received January 14, 2011

    Report

    Report Number
    2953200-2011-00106
    Event Type
    Death
    Date Received
    January 14, 2011
    Date of Event
    June 26, 2010
    Report Date
    February 9, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: (MI, STENT THROMBOSIS, CVA, DEATH).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENTS WERE IMPLANTED IN THE DISTAL LCX (MFR REPORT # 2953200201001349, 2953200201001350). APPROX 3 WEEKS POST INDEX PROCEDURE THERE WAS FURTHER TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENTS IMPLANTED AS A STAGED PROCEDURE. ONE IN THE PROXIMAL LAD (MFR REPORT # 2953200-2011-00105) AND ONE IN THE MID LAD. THERE WAS A PTCA (BALLOON ONLY) REVASCULARIZATION OF THE DISTAL LAD CARRIED OUT ON THE SAME DAY. AT 1 MONTH F/U PT'S CARDIAC STATUS WAS STABLE ANGINA. APPROX 6 WEEKS POST INDEX PROCEDURE AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL AS A SECOND STAGED PROCEDURE (MFR REPORT # 2953200201001351). AT 6 MONTH AND 1 YR F/U'S PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS. AT 1.5 YR F/U PT'S CARDIAC STATUS WAS STABLE ANGINA. APPROX 20 MONTHS POST INDEX PROCEDURE STENT THROMBOSIS WAS REPORTED TO HAVE OCCURRED IN THE MID CIRCUMFLEX AND THE 1ST OBTUSE MARGINAL. STENOSIS DIAMETER WAS REPORTED TO BE GREATER THAN 70%. ASSOCIATED CLINICAL SIGNS AND SYMPTOMS WERE ANGINA. ANGIOGRAPHY SHOWED THE DES IN THE MID LCX WAS OCCLUDED, THE DES IN THE MID RCA WAS 70-90% OCCLUDED AND 1ST OBTUSE MARGINAL DES OCCLUDED. PROXIMAL LAD <50% OCCLUDED, MID LAD NO ABNORMALITIES, DISTAL LAD 90% OCCLUSION. PT WAS NOT TAKING ASA BUT WAS TAKING CLOPIDOGREL / TICLOPIDINE 24 HRS PRIOR TO EVENT. INVESTIGATOR HAS INDICATED THAT IT IS NOT ASSESSABLE IF THE EVENT WAS RELATED TO THE STUDY STENTS. A NON-TARGET VESSEL REVASCULARIZATION OF THE MID RCA WAS CARRIED OUT APPROX 3 WEEKS LATER. ONE OTHER BRAND STENT WAS IMPLANTED. AN ACUTE NON-STEMI IS REPORTED TO HAVE OCCURRED APPROX 5 MONTHS LATER. IT IS REPORTED THAT PT WAS ADMITTED FOR CHEST PAIN. PT WAS TAKING ASA AND CLOPIDOGREL 24 HRS PRIOR TO EVENT. IT IS REPORTED THAT THE TARGET LESION WAS NOT INVOLVED. LOCATION OF INFARCTION WAS REPORTED AS ANTERIOR. INVESTIGATOR ASSESSED THE EVENT WAS A NON-Q-WAVE MI. A CAG IS REPORTED TO HAVE BEEN CARRIED OUT 3 DAYS LATER. AFTER CAG, SYMPTOMS OF CVA WERE PRESENT. IT IS REPORTED THAT EVENT WAS NOT RELATED TO THE STUDY STENT. PT WAS TAKING ASA AND CLOPIDOGREL 24 HRS PRIOR TO EVENT. THE FOLLOWING WAS REPORTED ON THE SAME DAY PROXIMAL SUBTOTAL LAD STENOSIS, OPEN STENT RCA, CLOSED RCX ALREADY PRESENT. SUDDEN PT DEATH IS REPORTED TO HAVE OCCURRED THE NEXT DAY. IT IS REPORTED THAT THE DEATH WAS ASSOCIATED WITH AN MI & THAT THERE WAS EVIDENCE OF STENT THROMBOSIS. INVESTIGATOR PROVIDED SUMMARY OF EVENT: CARDIAC INSUFFICIENCY IN OLD AND POSSIBLY REINFARCTION BY ALMOST DENSE STENT IN THE LAD. THE RCX WAS CLOSED. ATHEROSCLEROSIS BRAINS. CONGESTIVE HEART FAILURE. INVESTIGATOR INDICATED THAT EVENT WAS RELATED TO STUDY STENT. PT WAS TAKING ASA AND CLOPIDOGREL 24 HRS PRIOR TO EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A STENT THROMBOSIS EVENT OCCURRED IN THE PROXIMAL LAD ON THE SAME DAY AS THE CVA. A CORONARY ANGIOGRAM SHOWED SUBTOTAL STENOSIS IN THE APPLY PROXIMAL LAD. THE DIAMETER STENOSIS WAS >70%. AN AUTOPSY SHOWED THAT THE PROXIMAL LAD STENT WAS ALMOST TOTALLY OCCLUDED PATIENT WAS TAKING CLOPIDOGREL/ TICLOPIDINE 24 HOURS PRIOR TO THE EVENT. THE INVESTIGATOR CONFIRMED THAT IT IS NOT ASSESSABLE IF THE EVENT WAS RELATED TO THE STUDY STENT, AND THAT THE EVENT WAS NOT RELATED TO THE STUDY PROCEDURE (REF MFR #2953200201001349, 2953200201001350, 2953200201001351, 2953200201100105, 2953200201100106).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000508617

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Death 24 HOURS PRIOR TO EVENTS.| ASA| CLOPIDOGREL| CLOPIDOGREL| 24 HOURS PRIOR TO EVENTS.| ASA