BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER CATHETER

    MDR report key: 1490009 · Received October 1, 2009

    Report

    Report Number
    1721279-2009-00051
    Event Type
    Death
    Date Received
    October 1, 2009
    Date of Event
    September 10, 2009
    Report Date
    September 10, 2009
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    LPC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPNC DEVICES WERE DISPOSED OF AT THE HOSPITAL BUT PERFORMED AS DESIGNED, AND THERE WERE NO ALLEGED DEFECTS OR MALFUNCTIONS. DEVICE LOT NUMBERS WERE NOT AVAILABLE FOR REVIEW.

    Description of Event or Problem · 1

    THIS IS A REPORT OF AN EVENT WHICH OCCURRED IN FOREIGN COUNTRY. INDICATION FOR THE PROCEDURE: THE PROCEDURE WAS FOR A STAGED PCI TO THE LAD WHICH HAD A COMPLEX CALCIFIED STENOSIS IN THE MID LAD JUST DISTAL TO A LARGE DIAGONAL WHICH WAS ITSELF SIGNIFICANTLY DISEASED. PROCEDURE DETAILS: THE PROCEDURE BEGAN USING A 1.4MM CATHETER BUT ENCOUNTERED AN OBSTRUCTIVE LESION. THE MD DOWNSIZED TO A .9MM CATHETER IN ORDER TO CROSS SUCCESSFULLY. ON THE NEXT CONTRAST INJECTION, IT WAS CLEAR THERE WAS A SIGNIFICANT PERFORATION OF THE LAD WITH CONTRAST EXTRAVASATION INTO THE PERICARDIUM. THEY THEN PLACED THE TSUNAMI STENTS WHICH SEALED THE PERFORATION. THERE WAS GOOD ANGIOGRAPHIC RESULT AT THE END WITH NO FURTHER LEAK FROM THE MID LAD. JUST BEFORE COMPLETING THE CASE, THE PT HAD DEVELOPED FURTHER CHEST PAIN WITH THE ST SEGMENT CHANGES IN THE ANTERIOR LEADS AND ON FURTHER CORONARY ANGIOGRAPHY, IT WAS CLEAR HE WAS DEVELOPING SIGNIFICANT THROMBUS WITHIN THE LAD STENTED SEGMENT. THE MD PERFORMED TREATMENT WITH DRUG ADMINISTRATION AND WITHIN HALF AN HOUR, THE PATIENT'S ECG HAD SETTLED AND CHEST PAIN HAD RESOLVED. THE PT WAS THEN TRANSFERRED TO CORONARY CARE. THE MD WAS CONCERNED THAT THERE WAS PERSISTENT BLEEDING INTO THE PERICARDIAL SPACE AND THEREFORE, ELECTED TO BRING HIM BACK TO THE CATHETER LAB FOR FURTHER INVESTIGATION. ON ARRIVAL IN THE CATHETER LAB, THE PT IMMEDIATELY HAD A CARDIAC ARREST AND REQUIRED CPR IN ADDITION TO AIRWAY MANAGEMENT AND INOTROPIC SUPPORT. BLOOD PRESSURE WAS RESTORED WITH AN INTRA-AORTIC BALLOON PUMP FROM THE RIGHT FEMORAL ARTERY AND ACCESSED THE LAD FROM THE LEFT FEMORAL ARTERY WITH AN EBU 3.5L GUIDING CATHETER. ANOTHER LEAK OCCURRED WHICH WAS CONTROLLED WITH FURTHER BALLOON INFLATION; HOWEVER, BY NOW THE PT HAD LOST SIGNIFICANT VOLUMES OF BLOOD AND MULTIPLE BLOOD TRANSFUSIONS. THE MD ATTEMPTED TO DELIVER FURTHER COVERED STENTS, BUT WERE NOT SUCCESSFULLY DELIVERABLE. IT BECAME CLEAR THAT THE PATIENT'S CONDITION WAS WORSENING DESPITE HAVING EFFECTIVELY SEALED THE PERFORATION. THE PT WAS TRANSFERRED BACK TO CORONARY CARE WHERE SUPPORTIVE TREATMENT WAS WEANED. HE PASSED AWAY AND WAS PRONOUNCED DEAD IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER CATHETER 1.4MM AND .9MM ELCA LPC SPECTRANETICS CORP. 114-004 / 110-004

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death SPECTRANETICS CVX-300 LASER SYSTEM