BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 728081 · Received June 20, 2006

    Report

    Report Number
    3004742046-2006-00280
    Event Type
    Injury
    Date Received
    June 20, 2006
    Date of Event
    June 1, 2006
    Report Date
    June 2, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONESYMPTOMS: CHEST PAINTIME OF SYMPTOMS: 1 HOUR POST-OPIT WAS REPORTED THAT A PATIENT WITH A HISTORY OF UNSTABLE ANGINA, PREVIOUS MI AND CABG HAD CHEST PAIN THE NIGHT BEFORE THE RIGHT INTERNAL CAROTID STENTING PROCEDURE BUT DID NOT INFORM ANYONE. THE RIGHT CAROTID STENTING PROCEDURE WAS COMPLETED WITHOUT PROBLEMS EXCEPT FOR SOME TRANSIENT HYPOTENSION AND BRADYCARDIA THAT RESOLVED THE SAME DAY WITH DOPAMINE. WITHIN AN HOUR POST-OP, THE PATIENT COMPLAINED OF 10/10 MIDSTERNAL CHEST PAIN RADIATING TO THE BACK, RELIEVED WITH SL NITROGLYCERIN TIMES TWO. AN ECG DONE AT THAT TIME SHOWED SINUS RHYTHM AND NO ISCHEMIA. SERIAL TROPONIN LEVELS, COLLECTED IN 2006, WERE ELEVATED AT 6.4, 7.3, AND 7.6 RESPECTIVELY. CPKS WERE ELEVATED AT 148, 230,202, AND 172 RESPECTIVELY. CHEST X-RAY SHOWED CONGESTIVE HEART FAILURE CARDIAC CATHETERIZATION, DONE THE FOLLOWING DAY REVEALED 3 VESSEL CORONARY ARTERY DISEASE: LAD 90%, DIFFUSE RCA 90% WITH FILLING DEFECT DISTALLY, CIRCUMFLEX WITH PATENT STENT, OM1 90%, EJECTION FRACTION 56%, AND INFERIOR WALL AKINESIS. THREE PREVIOUS BYPASSES WERE PATENT. UNSUCCESSFUL PTCA OF THE OM1 WAS ATTEMPTED WITH SPIRAL OSTIAL DISSECTION AFTER BALLOON INFLATION AND USING A NON-ABBOTT VASCULAR STENT. THE PATIENT HAD NO CHEST PAIN OR ECG CHANGES AT THAT TIME. THE PATIENT HAD NO FURTHER CHEST PAIN DURING HOSPITALIZATION AND WAS DISCHARGED TO HOME 3 DAYS LATER. THE PHYSICIAN'S IMPRESSION AT THE TIME OF DISCHARGE WAS NOTED AS NON-Q MI. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM GUIDANT ENDOVASCULAR SOLUTIONS NA 5110151

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R DILATATION CATHETER: VIATRAC 5.0, OTHER: RX| ACCUNET 5.5