BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK CORONARY (VIPERWIRE, ADVANCE)

    MDR report key: 19821177 · Received July 24, 2024

    Report

    Report Number
    3004742232-2024-00268
    Event Type
    Death
    Date Received
    July 24, 2024
    Date of Event
    July 3, 2024
    Report Date
    September 6, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC. (ABBOTT)
    Product Code
    MCX
    UDI-DI
    10850026568698
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONTINUATION: GUIDEWIRE, VIPERWIRE ADVANCE CORONARY FLEX TIP INFORMATION: MODEL NUMBER: GWC-12325LG-FT, CATALOG NUMBER: 7-10038-01, LOT NUMBER: 523846-1, PRIMARY UDI: NUMBER: (B)(4), DEVICE MANUFACTURE DATE: 01/17/2024, EXPIRATION DATE: 01/31/2026. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MATERIAL INSPECTION REPORT FOR THIS GUIDEWIRE LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. H6: INVESTIGATION CONCLUSION CODE 22: THE DIAMONDBACK 360® CORONARY ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE MANUAL STATES THAT PERFORATION OF VESSELS AND CARDIAC ARREST ARE POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION WITH USE OF THE SYSTEM. CSI ID: (B)(4)

    Additional Manufacturer Narrative · 0

    UPDATED: A3A, A4, A5, B4, G1, G2, G3, G6, H2. CSI ID: (B)(4).

    Description of Event or Problem · 0

    A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF HEAVILY CALCIFIED, 95% STENOSED, NON-TORTUOUS LESION IN THE DIAGONAL TO LEFT ANTERIOR DESCENDING (LAD) ARTERY IN LEFT MAIN (LM) CORONARY ARTERY VIA RADIAL APPROACH. THE VESSEL DIAMETER WAS ABOUT 3.0MM. THE PLAN WAS TO WIRE THE LAD, BUT THE PHYSICIAN COULD NOT GET THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP OR ANY WIRE TO CROSS THE LESION. A LONG ABBOTT WHISPER WIRE WAS PRIMARILY USED TO WIRE THE LESION AND WAS EXCHANGED FOR A VIPERWIRE. FOLLOWING THREE LOW-SPEED TREATMENTS, THE PATIENT MOVED AND CAUSED THE OAD CROWN TO COME IN CONTACT WITH THE VIPERWIRE TIP WHILE SPINNING AND SHEARED IT OFF. THE VIPERWIRE TIP WAS LEFT IN THE DIAGONAL ARTERY. THE OAD CROWN DID NOT JUMP PRIOR TO THE FRACTURE. ANGIOGRAPHIC IMAGING OBSERVED PERFORATION IN THE DIAGONAL ARTERY. AFTER THE VIPERWIRE FRACTURE CAUSED THE PERFORATION, THE AREA COULD NOT BE REWIRED. IT TOOK TWENTY MINUTES TO REWIRE THE VESSEL. THE PATIENT CODED. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND MEDICATION INCLUDING EPINEPHRINE, DOPAMINE AND VASOPRESSOR WERE ADMINISTERED. THE PATIENT WAS REVIVED. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN FLUID AROUND THE HEART. A NON-CSI/NON-ABBOTT BALLOON WAS INFLATED TO RESOLVE THE PERFORATION. NON-ABBOTT STENT PLACEMENT WAS PERFORMED ON OSTIAL LEFT MAIN ARTERY AS PLANNED UNRELATED TO PERFORATION. NO MEDICAL INTERVENTION WAS PERFORMED TO RETRIEVE THE VIPERWIRE TIP DUE TO THE PHYSICIAN PRIORITIZING THE PERFORATION. THE PHYSICIAN HAD NO CONCERNS ABOUT POTENTIAL LONG-TERM RISKS/OUTCOMES RELATED TO THE VIPERWIRE TIP BEING LEFT IN LAD DUE TO ITS NON-FLOW LIMITING NATURE AND BEING PINNED TO THE ARTERY WALL WITH A BALLOON. AFTER THE PATIENT CODED FOR AN HOUR, THE LESION WAS DEEMED TOO CALCIFIED FOR TREATMENT AND THE PROCEDURE WAS ABORTED. A HEART PUMP WAS PLACED VIA FEMORAL APPROACH. THE PATIENT WAS ADMITTED IN INTENSIVE CARE UNIT (ICU) AND INTUBATED. IN THE OPINION OF THE PHYSICIAN, THE OAD AND THE VIPERWIRE CAUSED OR CONTRIBUTED TO THE PERFORATION ALONG WITH PATIENT ANATOMY. ON 24JULY2024, THE SALES REPRESENTATIVE INDICATED THAT THE PATIENT EXPIRED LATER THE DAY OF THE PROCEDURE. IN THE OPINION OF THE PHYSICIAN, THE PRIMARY CAUSE OF EXPIRATION WAS HEART FAILURE DUE TO THE HIGH-RISK PATIENT NOT BEING A CANDIDATE FOR BYPASS; THE PATIENT HAD A VERY WEAK HEART AND SUFFERED TWO CARDIAC ARRESTS PRIOR TO THE DAY OF THE PROCEDURE. THE SECONDARY CAUSE OF EXPIRATION IS PERFORATION FROM THE CSI DEVICE AS THE PATIENT WAS UNABLE TO RECOVER FROM THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482132 DIAMONDBACK CORONARY (VIPERWIRE, ADVANCE) CORONARY ATHERECTOMY DEVICE (GUIDEWIRE) MCX CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) DBEC-125 530022-1 10850026568698

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Hospitalization| D| R GUIDEWIRE, VIPERWIRE ADVANCE CORONARY FLEX TIP.