BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIBE RX VASCULAR IMAGING BALLOON CATHETER

    MDR report key: 1938706 · Received December 23, 2010

    Report

    Report Number
    2939520-2010-00050
    Event Type
    Death
    Date Received
    December 23, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT HISTORY AND MFG DOCUMENTS WERE REVIEWED. (B)(4). THE VIBE RX VASCULAR IMAGING BALLOON CATHETER WAS DISCARDED BY THE HOSPITAL; THEREFORE, NO ADD'L TESTING WILL BE PERFORMED ON THE CATHETER. GIVEN THE FACTS RECEIVED TO DATE, IT WAS THE IMPRESSION FROM THE PHYSICIAN THAT THE VIBE CATHETER WAS NOT THE CAUSE OF THE DEATH IN THIS SITUATION. FURTHER CLARIFICATION FROM THE HOSPITAL STATED THAT THE EVENTS HAD NO RELATION TO THE USE OF THE COMBINED IVUS/BALLOON CATHETER. INITIAL PRE-DILATATION WAS ACHIEVED AND THE IVUS IMAGES GAVE THE PHYSICIAN REASSURANCE THAT THE OLD STENT (WITH IN-STENT RESTENOSIS) WAS WELL EXPANDED AT THE TIME OF INITIAL IMPLANTATION. THE CASE WAS REVIEWED BY THE HOSPITAL AND NO IVUS OR PRE-DIL ISSUES WERE IDENTIFIED. NOR THE HOSPITAL OR THE PHYSICIAN IS REPORTING THIS AS A COMPLAINT AGAINST THE VIBE CATHETER. THE CAUSE OF DEATH IS UNCLEAR. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT.

    Description of Event or Problem · 1

    THE PATIENT WAS FEMALE (B)(6) WITH CHEST PAIN. ANGIOGRAM WAS PERFORMED AND REVEALED 3 VESSEL DISEASE. THERE WAS AN IN-STENT RESTENOSIS OF THE RIGHT CORONARY ARTERY (RCA). STENTS APPEARED ON THE ANGIOGRAM TO EXTEND FROM THE PROXIMAL TO THE DISTAL END OF THE VESSEL. THERE WAS ALSO A TIGHT PROXIMAL LESION IN THE LEFT CIRCUMFLEX ARTERY (LCX). THERE WAS EVIDENCE OF IN STENT RESTENOSIS AFTER THE BIFURCATION WITH THE MARGINAL ARTERY, AND THE OSTIAL PORTION ALONG WITH A PROXIMAL LESION OF THE MARGINAL ARTERY. THE LEFT ANTERIOR DESCENDING ARTERY (LAD) SHOWED EVIDENCE OF DISEASE. A VIBE CATHETER 2.0 X 15MM WAS USED AS THE PRIMARY DEVICE IN LCX TO OPEN TIGHT LESION AND ASSESS THE PROXIMAL PART OF THE VESSEL. AFTERWARDS, SEVERAL DEVICES WERE USED TO TREAT IN STENT RESTENOSIS IN LCX AND TREAT PROXIMAL PART OF THE MARGINAL. SEVERAL PRODUCTS WERE USED, INCLUDING SEVERAL SIZES OF THE MEDTRONIC SPRINTER BALLOON, AND SEVERAL SIZES OF ABBOTT XCIENCE V STENT. THE ACCESS TO THE MARGINAL WAS VERY DIFFICULT AND THE DIFFERENT BALLOONS AND STENTS COULD NOT ENTER THE VESSEL. ACCORDING TO A VOLCANO REP PRESENT DURING THE CASE, IT WAS OBSERVED THAT A DISSECTION OCCURRED IN THE MARGINAL WHEN THE PHYSICIAN TRIED TO PUSH A STENT ON ITS BALLOON INSIDE OF THE VESSEL. THE PATIENT BECAME HEMODYNAMICALLY COMPROMISED AND THE OXYGEN SATURATIONS BEGAN TO FALL RAPIDLY, APPROPRIATE MEASURES WERE TAKEN TO SAVE THE PATIENT, TO NO AVAIL. THE PATIENT EXPIRED IN THE CARDIAC CATHETERIZATION LABORATORY AND WAS NOT TRANSFERRED TO THE OPERATING ROOM FOR CORONARY ARTERY BYPASS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIBE RX VASCULAR IMAGING BALLOON CATHETER IVUS IMAGING BALLOON CATHETER OBJ VOLCANO CORPORATION 11-200-15 093 01014

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SEVERAL SIZES OF SPRINTER BALLOON| SEVERAL SIZES OF XCIENCE V STENT