BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1728352 · Received June 14, 2010

    Report

    Report Number
    2024168-2010-01178
    Event Type
    Death
    Date Received
    June 14, 2010
    Date of Event
    April 17, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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. THE 2.5 X 12 MM XIENCE V (P.N. 1009539-12, LOT# 9080641) IS BEING REPORTED UNDER THIS SAME MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVICE EVENT: DEATH. ONSET OF ADVERSE EVENT: APPROXIMATELTY 5 MONTHS AFTER STENT IMPLANTATION. IT WAS REPORTED, VIA STUDY, THAT APPROXIMATELY 5 MONTHS POST A MID LEFT ANTERIOR DESCENDING (LAD) ARTERY STENTING PROCEDURE, THE PATIENT EXPIRED. FROM (B) (6) 2010 UNTIL (B) (6) 2010, THE PATIENT WAS HOSPITALIZED, INITIALLY FOR ELECTIVE ALCOHOL SEPTAL ABLATION; HOWEVER, THIS WAS COMPLICATED BY A LARGE NECK HEMATOMA REQUIRING INTUBATION AND SURGICAL EXPLORATION, THIRD DEGREE AV BLOCK, EPISODES OF PAROXYSMAL ATRIAL FIBRILLATION, ATRIAL FLUTTER AND AN EPISODE OF NONSUSTAINED VENTRICULAR TACHYCARDIA. ON (B) (6) 2010, DC CARDIOVERSION AND PLACEMENT OF AN ICD PACEMAKER WAS PERFORMED. ON (B) (6) 2010, THE PATIENT STABILIZED AND WAS DISCHARGED TO HOME. ON (B) (6) 2010, THE PATIENT EXPERIENCED SUDDEN DEATH AT HOME. THERE WAS NO CAUSE OF DEATH PROVIDED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 9071741

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death STENT: 2.5 X 12 MM XIENCE V| (P.N. 1009539-12, LOT# 9080641)