BEUDAMED
    FDA Adverse Event Death Summary report: N

    APEX FLEX OVER-THE-WIRE

    MDR report key: 2233360 · Received September 2, 2011

    Report

    Report Number
    2134265-2011-03813
    Event Type
    Death
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW COULD NOT BE COMPLETED AS THE BATCH NUMBER WAS UNKNOWN. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-03684, 2134265-2011-03809, 2134265-2011-03810, 2134265-2011-03811, 2134265-2011-03812, 2134265-2011-03816, 2134265-2011-03817, 2134265-2011-03818, 2134265-2011-03819, 2134265-2011-03820. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A DISSECTION OCCURRED AND TWO DAYS POST PROCEDURE, THE PATIENT EXPIRED. THE PATIENT PRESENTED WITH ST ELEVATION MYOCARDIAL INFARCTION (STEMI). VASCULAR ACCESS WAS OBTAINED VIA THE LEFT AND RIGHT FEMORAL ARTERIES. A 6FR SHEATH WAS PLACED IN THE RIGHT FEMORAL VEIN AND A 5FR TEMPORARY PACEMAKER WAS INSERTED. THE PATIENT WAS BRADYCARDIC AND THE PACEMAKER WAS SET AT 75 PPM. AN 8FR INTRAAORTIC BALLOON PUMP (IABP) WAS PLACED IN THE LEFT FEMORAL ARTERY. THE FIRST LESION WAS 100% OCCLUDED AND LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). A 6FR GUIDE CATHETER WAS PLACED AT THE OSTIUM OF THE RCA. THE .014" 182CM CHOICE FLOPPY GUIDE WIRE WAS PLACED IN THE POSTERIOR DESCENDING ARTERY (PDA) WITH THE TIP PROLAPSED THROUGH THE LESION. A 2.0X12MM APEX BALLOON CATHETER WAS ADVANCED OVER THE WIRE TO THE RCA AND INFLATED TWICE TO 12 ATMS FOR 12 AND 17 SECONDS. ASPIRATION WAS THEN PERFORMED WITH A NON BSC ASPIRATION CATHETER. A 2.5X12MM APEX BALLOON CATHETER WAS ADVANCED OVER THE WIRE TO THE RCA AND INFLATED 6 TIMES TO 10 ATMS AND ONCE TO 14 ATMS RANGING FROM 6 TO 29 SECONDS. ASPIRATION WAS AGAIN PERFORMED WITH THE NON BSC CATHETER. THE 2.5X12MM APEX BALLOON CATHETER WAS PLACED IN THE RCA AND INFLATION WAS PERFORMED 2 TIMES TO 10 ATMS AND ONCE TO 12 ATMS RANGING FROM 8-30 SECONDS. A 3.0X28MM VERIFLEX STENT WAS DEPLOYED AT 12 ATMS/12 SEC. FLOW WAS RE-ESTABLISHED AND THE PHYSICIAN THEN DETERMINED THE BIFURCATION OF THE DISTAL PDA AND POSTEROLATERAL BRANCH (PLB) REQUIRED INTERVENTION. A .014" 300CM CHOICE FLOPPY GUIDE WIRE WAS PLACED IN THE PLB WITH THE TIP PROLAPSED THROUGH THE LESION. A 1.5X12MM APEX FLEX BALLOON CATHETER WAS ADVANCED OVER THIS WIRE TO THE PLB AND INFLATION WAS PERFORMED TWICE TO 16 ATMS FOR 26 AND 21 SECONDS. THE 2.0X12MM APEX BALLOON CATHETER WAS ADVANCED OVER THE PLB WIRE AND INFLATION WAS PERFORMED TO 8 ATMS 3 TIMES RANGING FROM 20-28 SECONDS. A 2.25X20MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED OVER THE PDA WIRE AND INFLATION WAS PERFORMED TWICE TO 12 ATMS AND ONCE TO 14 ATMS RANGING FROM 29-60 SECONDS. THE 2.25X20MM NC QUANTUM APEX WAS THEN ADVANCED OVER THE PLB WIRE AND INFLATION WAS PERFORMED TO 8 ATMS/74 SEC AND 14 ATMS/46 SEC. A 2.25X18MM NON BSC STENT WAS DEPLOYED IN THE PLB AT 9 ATMS/18 SEC. THE 2.25X20MM NC QUANTUM APEX WAS ADVANCED OVER THE PDA WIRE AND INFLATION WAS PERFORMED 3 TIMES TO 18 ATMS RANGING FROM 15-61 SECONDS. A 2.25X20MM EXPRESS2 STENT WAS DEPLOYED IN THE PDA AT 9 ATMS/11 SEC. A 2.5X15MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED OVER THE PDA WIRE FOR POST-DILATION OF THE EXPRESS2 AND INFLATION WAS PERFORMED ONCE TO 12 ATMS/16 SEC. THE 2.5X15MM NC QUANTUM APEX WAS THEN ADVANCED OVER THE PLB WIRE FOR POST-DILATION OF THE STENT IN THE PLB, INFLATION WAS PERFORMED TO 12 ATMS/18 SEC. A 3.0X20MM VERIFLEX STENT WAS ADVANCED TO THE PROXIMAL RCA. THE 182CM CHOICE FLOPPY GUIDE WIRE WAS REMOVED. DURING REMOVAL, THE DISTAL END OF THE WIRE DETACHED. IT WAS NOTED THAT THE DISTAL END OF THIS WIRE APPEARED TO BE STENTED AGAINST THE VESSEL WALL WITH ONE OF THE STENTS PLACED IN THE PLA/PDA. THE FRACTURED PORTION OF THE WIRE WAS POSSIBLY 15CM WITH 4-5CM OF THE WIRE EXTENDING OUTSIDE OF THE OSTIUM OF THE RCA INTO THE ASCENDING AORTA. THE VERIFLEX STENT IN THE PROXIMAL RCA WAS DEPLOYED AT 14 ATMS/18 SEC. A 3.5X20MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST-DILATION OF THE STENTS IN THE RCA. INFLATION WAS PERFORMED IN THE MID RCA 2 TIMES - 9 ATMS/12 SEC AND 12 ATMS/10 SEC. INFLATION WAS THEN PERFORMED ONCE IN THE PROXIMAL RCA TO 12 ATMS/10 SEC. THE NEXT DAY THE PATIENT RETURNED TO THE CATH LAB TWICE. DURING THE FIRST VISIT A TEMPORARY PACER WAS PLACED. A CT SCAN WAS THEN SCHEDULED FOR AN UNKNOWN REASON AND DURING TRANSPORT TO RADIOLOGY, THE PATIENT WAS NOT DOING WELL. SHE RETURNED TO THE CATH LAB FOR THE SECOND TIME. AN ANGIOGRAM WAS PERFORMED AND ANOTHER PHYSICIAN SUCCESSFULLY STENTED A DISSECTION IN THE OSTIUM OF THE RCA WHICH WAS NOTED TO BE VISIBLE AT THE COMPLETION OF THE PROCEDURE THE PREVIOUS DAY. TWO DAYS POST PROCEDURE, THE PATIENT EXPIRED. THE PATHOLOGIST WHO PERFORMED THE AUTOPSY REPORTED THAT THE GUIDE WIRE DETACHMENT DID NOT CONTRIBUTE TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX FLEX OVER-THE-WIRE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895812150

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| R .014¿ CHOICE FLOPPY 300CM GUIDE WIRE| 2.25X20MM NC QUANTUM APEX BALLOON CATHETER| 2.5X15MM NC QUANTUM APEX BALLOON CATHETER| 3.5X20MM NC QUANTUM APEX BALLOON CATHETER| 6FR FR4 GUIDE CATHETER| PRONTO V3 ASPIRATION CATHETER| 2.25X18MM MULTI-LINK MINIVISION STENT| 2.5X12MM APEX BALLOON CATHETER| 2.0X12MM APEX BALLOON CATHETER| 3.0X28MM VERIFLEX STENT| 2.25X20MM EXPRESS2 STENT| 3.0X20MM VERIFLEX STENT| .014¿ CHOICE 182CM FLOPPY GUIDE WIRE