BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BX VELOCITY SDS UNKNOWN

    MDR report key: 774754 · Received October 27, 2006

    Report

    Report Number
    9610978-2006-00423
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    February 21, 2006
    Report Date
    October 27, 2006
    Manufacturer
    CORDIS EUROPA
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT FROM THE AFFILIATE INDICATED THAT FOUR (4) DAYS AFTER THE INDEX PROCEDURE INVOLVING THE CYPHER STENTS, THE PATIENT WENT INTO CARDIOPULMONARY ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS DONE, BUT THE PATIENT EXPIRED. NO CORONARY ANGIOGRAPHY WAS DONE. THE PHYSICIAN'S COMMENTS REGARDING THE ADVERSE EVENT (AE) WERE THAT THE CAUSE OF DEATH WAS SUDDEN DEATH. NO AUTOPSY WAS DONE. IT IS ASSUMED BUT NOT CONFIRMED THAT A THROMBOTIC EVENT (SUB ACUTE THROMBOSIS) OCCURRED. THE POSSIBLE CAUSES OF THE THROMBOTIC EVENT WERE:THOUGH THE TARGET LESION WAS A BIFURCATION LESION OF THE LEFT MAIN TRUNK (LMT), A FINAL KISSING BALLOON TECHNIQUE (KBT) WAS NOT DONE. THE STENTS IMPLANTED IN THE LEFT CIRCUMFLEX WERE UNDER-DILATED. THE PATIENT'S EJECTION FRACTION (EF) WAS NOT GOOD-30%. THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THERE WERE THREE (3) TARGET LESIONS. LESION#1-1: THE LESION WAS THE PROXIMAL CIRCUMFLEX/OBTUSE MARGINAL (OM)/DISTAL CIRCUMFLEX. THE LESION WAS REPORTED TO BE: AN IN-STENT-RESTENOSIS (ISR) OF A BARE METAL STENT (BMS)-AS S670 3.5X13MM STENT, A BIFURCATION LESION, OVER 50MM IN LENGTH VESSEL DIAMETER OF 3.0MM, CALCIFIED, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 3.0X15MM BALLOON AT 12 ATM FOR 30 SEC. A CYPHER 3.0X23MM STENT (STENT #1) WAS IMPLANTED AT 18 ATM FOR 30 SEC. ANOTHER CYPHER 3.0X18 MM (STENT #2) WAS IMPLANTED AT 18ATM FOR 30 SEC PROXIMAL TO THE FIRST STENT (STENT #1) IN OVERLAPPING FASHION. ANOTHER CYPHER 3.0X23MM STENT (STENT #3) WAS IMPLANTED AT 18ATM FOR 30 SEC PROXIMAL TO THE SECOND (STENT #2) IN OVERLAPPING FASHION. LESION#1-2: THE LESION WAS THE LMT/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS REPORTED TO BE: AN IN-STENT-RESTENOSIS (ISR) OF A BARE METAL STENT (BMS)-A RADIUS 3.5X20 OR 14MM STENT, A BIFURCATION LESION, CALCIFIED, APPROXIMATELY 25MM, VESSEL DIAMETER OF 3.0MM, AND TYPE C. A CYPHER 3.0X28MM STENT (STENT#4) WAS IMPLANTED AT 20 ATM FOR 30 SEC. THE BIFURCATION PORTION OF THE LMT/PROXIMAL LAD AND THE PROXIMAL CIRCUMFLEX/OM/DISTAL CIRCUMFLEX WAS T-STENTED. POST-DILATATION WAS DONE WITH A 3.0X23MM BALLOON AT 18 ATM FOR 30 SEC. IVUS WAS DONE. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THE RESIDUAL STENOSIS WAS 0%. AN ACT WAS NOT MEASURED. LESION#1-3: THE LESION WAS THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS REPORTED TO BE: AN IN-STENT-RESTENOSIS (ISR) OF A BARE METAL STENT (BX STENT), ECCENTRIC, CALCIFIED, 26MM IN LENGTH, VESSEL DIAMETER OF 3.0MM, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.5X14MM BALLOON AT 8 ATM FOR 30 SEC. A CYPHER 3.0X33 MM STENT (STENT#5) WAS IMPLANTED AT 14 ATM FOR 30 SEC. THE STENT WAS POST-DILATED WITH A 3.0X15MM BALLOON AT 18 ATM FOR 30 SEC. IVUS WAS DONE. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THE RESIDUAL STENOSIS WAS 0%. OF NOTE, THE PATIENT WAS ON ANTIPLATELET THERAPY (TICLOPIDINE HYDROCHLORIDE 200 MG/DAY) FOR TEN DAYS IN 2005, BUT WAS DISCONTINUED DUE TO LIVER FAILURE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. THE CLINICAL IMPRESSION HAS BEEN AMENDED TO REFLECT NEW OR CORRECTED INFORMATION. A MALE PATIENT OF UNKNOWN AGE WITH A MEDICAL HISTORY OF PREVIOUS MI, ANGINA, HYPERTENSION, DIABETES, KIDNEY FAILURE WITH HEMODIALYSIS AND RENAL ANEMIA EXPERIENCED RESTENOSIS THIRTY-MONTHS POST BX VELOCITY STENT IMPLANTATION. THIS WAS THEN TREATED WITH CYPHER STENT IMPLANTATIONS. FOUR DAYS AFTER THIS LATEST PROCEDURE, THE PATIENT EXPIRED. THE REASON FOR THE PATIENT'S INITIAL ADMISSION TO HOSPITAL WAS NOT REPORTED; BUT AN ANGIOGRAM REVEALED A LESION IN HIS LM/PROXIMAL LAD. THIS PATIENT'S EXTENSIVE HISTORY PUTS HIM AT INCREASED RISK FOR MACE. THE PRE OR INTRA PROCEDURAL ADMINISTRATION OF ASA, PLAVIX, HEPARIN OR GPIIBIIIA AND THE PERFORMANCE OR RECORDING OF ACTS WAS NOT REPORTED. THE LM/PROXIMAL LAD LESION WAS DESCRIBED AS LOCATED IN A BIFURCATION. THE SAFETY AND EFFECTIVENESS OF THE BX VELOCITY STENT HAS NOT BEEN ESTABLISHED IN THESE TYPES OF VESSELS AND/OR LESIONS. IT IS NOT KNOWN IF THE LESION WAS PRE-DILATED PRIOR TO THE PLACEMENT OF A BX VELOCITY STENT OF UNKNOWN SIZE AT AN UNKNOWN MAXIMUM INFLATION PRESSURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON MEDICATIONS THAT INCLUDED TICLID. THE POST PROCEDURAL ADMINISTRATION OF ASA WAS NOT REPORTED. NINE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT'S TICLID WAS DISCONTINUED BECAUSE OF THE PATIENT'S LIVER FAILURE. IT IS NOT KNOWN IF OTHER MEDICATIONS WERE SUBSTITUTED FOR THE PATIENT'S TICLID. THIRTY MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT AN ELECTIVE ANGIOGRAM THAT REVEALED AN LVEF OF LESS THAN 30% AND LESIONS IN HIS LM/PROXIMAL LAD, PROXIMAL TO DISTAL CIRCUMFLEX AND MID RCA. THIS PATIENT'S DECREASED VENTRICULAR FUNCTION AND WIDESPREAD CAD PUT HIM AT INCREASED RISK FOR MACE. PRE PROCEDURAL MEDICATIONS INCLUDED ASA, CILOSTAZOL AND WARFARIN; WHILE INTRA PROCEDURAL MEDICATIONS INCLUDED HEPARIN. ACTS WERE NOT MEASURED DURING THE PROCEDURE. THE LM/PROXIMAL LAD WAS DESCRIBED AS AN ISR OF THE PREVIOUSLY IMPLANTED BX VELOCITY STENT, TYPCE C, 3MM IN DIAMETER, 25MM IN LENGTH, CALCIFIED AND LOCATED IN A BIFURCATION. THE PROXIMAL TO DISTAL CIRCUMFLEX WAS DESCRIBED AS AN ISR, TYPE C, 3MM IN DIAMETER, 50MM IN LENGTH, CALCIFIED AND LOCATED IN BIFURCATION. THE SAFETY AND EFFECTIVENESS OF THE CYPHER STENT HAS NOT BEEN ESTABLISHED IN THESE TYPES OF VESSELS AND/OR LESIONS. THE LM/PROXIMAL LAD AND PROXIMAL TO MID CIRCUMFLEX WERE FIRST PRE-DILATED PRIOR TO THE PROGRESSIVELY MORE PROXIMAL AND OVERLAPPING PLACEMENT OF THREE CYPHER STENTS; A 3.00X23MM, A 3.00X18MM AND A 3.00X23MM; AT MAXIMUM INFLATION PRESSURES OF 18ATM. ACCORDING TO THE IFU, THE RATED BURST PRESSURE OF THE CYPHER STENT SHOULD NOT BE EXCEEDED IN ORDER TO PREVENT INTIMAL DAMAGE OR VESSEL DISSECTION. THIS WAS THEN FOLLOWED BY THE PLACEMENT OF A 3.00X28MM CYPHER STENT AT A MAXIMUM INFLATION PRESSURE OF 20 ATM IN THE LM/PROXIMAL LAD USING T-STENTING TECHNIQUE. THE STENTS WERE THEN POST-DILATED FOR A RESULTANT TIMI FLOW OF 3 AND A RESIDUAL STENOSIS OF 0%. (MORE)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED FROM THE AFFILIATE INDICATED THAT THIS PATIENT HAD A BARE METAL STENT (BMS) IMPLANTED IN THE MID RIGHT CORONARY (RCA). THE BMS WAS REPORTED TO BE EITHER A 3.5X23MM OR A 3.5X18MM STENT. NO PRODUCT LOT NUMBER WAS AVAILABLE. APPROXIMATELY THIRTY (30) MONTHS AFTER THIS PROCEDURE, THE PATIENT WAS FOUND TO HAVE RESTENOSED THE BMS. AN ELECTIVE PROCEDURE WAS CONDUCTED. THE RESTENOTIC LESION IN THE MID RCA WAS PRE-DILATED WITH A 2.5X14MM BALLOON AT 8 ATM FOR 30 SEC. A CYPHER 3.0X33MM STENT (WHICH WAS CYPHER STENT #5 OF FIVE STENTS USED FOR THIS INTERVENTIONAL PROCEDURE) WAS IMPLANTED AT 14 ATM FOR 30 SEC. IVUS WAS DONE. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THE RESIDUAL STENOSIS WAS 0%. AN ACT WAS NOT MEASURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX VELOCITY SDS UNKNOWN CORONARY SDS/STENTS MAF CORDIS EUROPA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R CILOSTAZOL| POTASSIUM| ASPIRIN| 2.5 X 14MM BALLOON| WARFARIN| TICLOPIDINE HYDROCHLORIDE| HEPARIN