BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3863560 · Received June 10, 2014

    Report

    Report Number
    9612164-2014-00616
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    August 1, 2013
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ROOT CAUSE COULD NOT BE DETERMINED. MI. DEVICE NOT RETURNED FOR EVALUATION. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. CONCLUSIONS: MI. ROOT CAUSE COULD NOT BE DETERMINED. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4). OUTCOME WITH VARIOUS DRUG-ELUTING OR BARE METAL STENTS IN PATIENTS WITH ST-SEGMENT-ELEVATION MYOCARDIAL INFARCTION. CIRCINTERVENTIONS CARDIOVASC INTER AUGUST 2013. HTTP://CIRCINTERVENTIONS.AHAJOURNALS.ORG. THE INFORMATION COULD NOT BE MATCHED WITH OTHER INFORMATION KNOWN TO MEDTRONIC. ATTEMPT MADE TO OBTAIN ADDITIONAL DETAILS. DATE OF EVENT - DATE OF PUBLICATION (MONTH AND YEAR VALID ONLY).

    Description of Event or Problem · 1

    THE STUDY WAS AN ANALYSIS OF RANDOMIZED CLINICAL TRIALS COMPARING FDA APPROVED DURABLE STENT AND POLYMER DES (SIROLIMUS ELUTING STENT, PACLITAXEL ELUTING STENT, EVEROLIMUS-ELUTING STENT [EES], ZOTAROLIMUS-ELUTING STENT, AND ZOTAROLIMUS-ELUTING STENT RESOLUTE), AGAINST EACH OTHER OR BARE METAL STENTS (BMS), AND ENROLLING GREATER THAN OR EQUAL TO 50 PATIENTS WITH STEMI. EFFICACY OUTCOME WAS TARGET VESSEL REVASCULARIZATION (TVR). SAFETY OUTCOMES EVALUATED INCLUDED DEATH, MI, AND STENT THROMBOSIS. TWENTY-EIGHT RANDOMIZED CLINICAL TRIALS WITH 34068 PATIENT-YEARS OF FOLLOW-UP ON SUBJECTS WITH STEMI FULFILLED THE INCLUSION CRITERIA. WHEN COMPARED WITH BMS, SIROLIMUS ELUTING STENT, PACLITAXEL ELUTING STENT, AND EES WERE ASSOCIATED WITH A STATISTICALLY SIGNIFICANT REDUCTION IN RATE OF TARGET VESSEL REVASCULARIZATION, WITH THE POINT ESTIMATE FOR ZOTAROLIMUS-ELUTING STENT RESOLUTE TRENDING IN A SIMILAR DIRECTION. THERE WAS NO INCREASE IN THE RISK OF DEATH, MYOCARDIAL INFARCTION, OR STENT THROMBOSIS WITH ANY DES COMPARED WITH BMS. MOREOVER, EES WAS ASSOCIATED WITH A STATISTICALLY SIGNIFICANT REDUCTION IN THE RATE OF STENT THROMBOSIS WHEN COMPARED WITH SIROLIMUS ELUTING STENT, PACLITAXEL ELUTING STENT, AND EVEN BMS. THERE WAS A 74% PROBABILITY THAT EES HAD THE LOWEST RATE OF ANY STENT THROMBOSIS WHEN COMPARED WITH ALL OTHER STENT TYPES (NO DATA ON ZOTAROLIMUS-ELUTING STENT RESOLUTE). THERE WAS NO INCREASE IN VERY LATE STENT THROMBOSIS WITH EES VERSUS BMS. THE ARTICLE CONCLUDED THAT IN PATIENTS WITH STEMI, DES VERSUS BMS WAS ASSOCIATED WITH SUBSTANTIAL DECREASE IN THE RISK OF TARGET VESSEL REVASCULARIZATION WITHOUT COMPROMISING SAFETY. EES HAD THE ADDED ADVANTAGE OF SUBSTANTIAL REDUCTION IN THE RISK OF STENT THROMBOSIS WHEN COMPARED WITH FIRST-GENERATION DES AND BMS WITH NO INCREASE IN VERY LATE STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338039 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1