BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1914686 · Received December 3, 2010

    Report

    Report Number
    2024168-2010-02602
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 26, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. STENT: 3.5 X 23 MM PROMUS (PART 1009542-23B, LOT UNK), 3.5 X 18 MM PROMUS (PART 1009542-18B, LOT UNK) THERE WAS NO REPORTED PRODUCT DEFICIENCY. CARDIAC ARREST AND DEATH ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR IN-STENT RESTENOSIS (ISR) OF THREE NON-ABBOTT STENTS FROM A PREVIOUS PROCEDURE. THE LESIONS WERE FROM THE OSTIUM OF LEFT MAIN TRUNK TO THE FIRST DIAGONAL OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THREE PROMUS STENTS WERE DEPLOYED DURING THE REVASCULARIZATION PROCEDURE. A 3.5 X 23 MM IN THE LEFT MAIN, A 3.5 X 18 MM IN THE PROXIMAL LAD, AND A 2.75 X 12 MM IN THE MID LAD. THE FIRST TWO PROMUS (3.5X23 AND 3.5X18) WERE DEPLOYED FOR THE TREATMENT OF THE ISR. ON (B)(6) 2010, THE PATIENT WAS TRANSPORTED IN CARDIOPULMONARY ARREST AND AN EMERGENCY PROCEDURE WAS PERFORMED. ANGIOGRAPHY REVEALED A TOTAL OCCLUSION OF THE ISR. NO THROMBOSIS WAS OBSERVED. BALLOONING WAS PERFORMED, BUT THE PATIENT PASSED AWAY. THE PHYSICIAN COMMENTED THAT THE PATIENT'S HEART FUNCTION HAD BEEN DETERIORATING AND THE PROMUS DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CONCOMITANT PRODUCTS