BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1253189 · Received December 5, 2008

    Report

    Report Number
    2024168-2008-01314
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 6, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMATION - DISSECTION MYOCARDIAL INFARCTION, OCCLUSION, ISCHEMIA, AND EDEMA AS NOTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THE 3.0 X 12 MM XIENCE V INDICATED IN B5 AND D11 IS BEING REPORTED UNDER THIS SAME MFR REPORT #. THE 2.5 X 08 MM XIENCE V AND 2.5 X 12 MM XIENCE V ARE BEING REPORTED UNDER DIFFERENT MFR REPORT NUMBERS.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: PULMONARY EDEMA WITH EXTREME SHORTNESS OF BREATH REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT IN 2008, A 2.5 X 28 MM RX XIENCE V STENT WAS IMPLANTED IN THE DISTAL LAD. A 2.5 X 12 MM RX XIENCE V STENT WAS IMPLANTED; HOWEVER, PLAQUE SHIFT OCCURRED AND AN OCCLUSION WAS NOTED. A 2.5 X 8 MM RX XIENCE V STENT WAS USED TO TREAT THE OCCLUSION BUT THERE WAS POOR OUTFLOW (ISCHEMIA). A DISSECTION WAS NOTED PROXIMAL TO THE 2.5 X 8 MM XIENCE V STENT. A 3.0 X 12 MM RX XIENCE V STENT WAS IMPLANTED TO TREAT THE DISSECTION. INTRACORONARY NITROGLYCERINE AND IC VERAP WERE ADMINISTERED TO TREAT THE ISCHEMIA. AFTER THE PROCEDURE, THE PT EXPERIENCED FLASH PULMONARY EDEMA, MYOCARDIAL INFARCTION AND SHORTNESS OF BREATH (DYSPNEA). THE PT HAD TO BE INTUBATED AND GIVEN MEDICATION. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO EXTUBATE THE PT. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 7111941

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R 2.5 X 8MM RX XIENCE V| 3.0 X 12MM RX XIENCE V (1009541-12/8052861)| STENT: 2.5 X 12MM RX XIENCE V