BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 1789958 · Received August 6, 2010

    Report

    Report Number
    2953200-2010-01501
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    July 7, 2010
    Report Date
    December 5, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PT CODE: 2688 - LABELED NA. DEVICE CODE: 2993 - LABELED NA.

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    IT IS REPORT THAT DURING THE REVASCULARIZATION CARRIED OUT POST MI THERE WERE 2 OTHER BRAND STENTS IMPLANTED IN BOTH THE MID RCA AND THE DISTAL RCA. IT IS REPORTED THAT AT 1 5 YEAR AND 2 YEAR FOLLOW UPS PATIENTS CARDIAC STATUS WAS STABLE ANGINA. IT IS REPORTED THAT THE PATIENT WAS ADMITTED FOR HEART CATHERIZATION APPROXIMATELY 25 MONTHS POST INDEX PROCEDURE TO EVALUATE FATIGUE AND SHOULDER PAIN. A PCI REVASCULARIZATION WAS CARRIED OUT. TWO OTHER BRAND STENTS WERE IMPLANTED, ONE IN THE PROXIMAL RCA AND ONE IN THE RPDA TO TREAT IN-STENT RESTENOSIS.

    Description of Event or Problem · 0

    PREVIOUSLY REPORTED CABG PROCEDURE APPROXIMATELY 54 MONTHS POST INDEX PROCEDURE WAS FOR TREATMENT OF ANGINA, WORSENING. INVESTIGATOR ASSESSED THE EVENT TO BE POSSIBLY RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 0

    PREVIOUSLY REPORTED CABG APPROXIMATELY 54 MONTHS POST INDEX PROCEDURE INCLUDED TREATMENT TO THE LAD.

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS: MYOCARDIAL INFARCTION, REVASCULARIZATION.

    Description of Event or Problem · 1

    THERE WERE FOUR ENDEAVOR SPRINT OVER THE WIRE(OTW) DRUG-ELUTING STENTS IMPLANTED, ONE OF THE LEFT MAIN, ONE IN THE MID RCA AND TWO IN THE RIGHT PDA (REFERENCE MFR #'S 2853200-2010-01500, 01502, 01503). AT 30 DAYS FOLLOW UP, PATIENT'S CARDIAC STATUS WAS STABLE ANGINA. PATIENT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 6 MONTHS FOLLOW UP. APPROXIMATELY ONE YEAR POST INDEX PROCEDURE, PATIENT WAS WORKING AND GOT REAL SWEATY AND HAD SHORTNESS OF BREATH AND DEVELOPED CHEST HEAVINESS RADIATING TO SHOULDERS. IT WAS REPORTED THAT THE PATIENT PRESENTED TO LOCAL EMERGENCY ROOM. PATIENT WAS PRESCRIBED NOTIR AND MORPHINE. IT IS REPORTED THAT AN ACUTE NON-STEMI OCCURRED AND A REVASCULARIZATION OF TWO LESIONS WAS CARRIED OUT. AT 12 MONTHS FOLLOW UP, PATIENT'S CARDIAC STATUS WAS UNSTABLE ANGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410853 ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention UNK.