BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER BX JAPAN 2.50 X 28 MM

    MDR report key: 6854240 · Received September 11, 2017

    Report

    Report Number
    9616099-2017-01414
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    July 1, 2017
    Report Date
    September 8, 2017
    Manufacturer
    CORDIS CASHEL
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED IN A LITERATURE PUBLICATION, NINE-YEAR FOLLOW-UP OF PROGRESSIVE PERI-STENT CONTRAST STAINING (PSS) AFTER CYPHER SIROLIMUS-ELUTING STENT IMPLANTATION: A CASE REPORT; A (B)(6) MALE WAS REFERRED TO OUR HOSPITAL WITH A COMPLAINT OF REPETITIVE CHEST OPPRESSION AT REST. HE HAD NO HISTORY OF ALLERGIC DISEASES OR VASCULITIS, BUT WAS TAKING 10 MG OF NIFEDIPINE AND 100 MG OF CILOSTAZOL FOR HYPERTENSION AND SINUS BRADYCARDIA. ELECTROCARDIOGRAPHY AND ECHOCARDIOGRAPHY INDICATED MYOCARDIAL ISCHEMIA IN THE INFERIOR WALL. EMERGENCY CAG AND PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE RIGHT CORONARY ARTERY WERE PERFORMED. TRIPLE ANTIPLATELET THERAPY WITH 100 MG OF ASPIRIN, 200 MG OF TICLOPIDINE, AND 100 MG OF CILOSTAZOL WAS INITIATED. THREE DAYS LATER, HE UNDERWENT A STAGED PCI FOR THE LEFT ANTERIOR DESCENDING ARTERY. CYPHER SIROLIMUS-ELUTING STENTS (C-SES) WERE SELECTED BASED ON THE ASSUMPTION OF A HIGHER RESTENOSIS RATE OF LESIONS IN THE DIAGONAL BRANCH DUE TO THE SMALL SIZE OF THIS VESSEL COMPARED TO THE MAIN LEFT ANTERIOR DESCENDING ARTERY AND THE GREATER LENGTH OF THE ASSOCIATED LESIONS. ONE MONTH LATER, A SECOND ELECTIVE PCI WAS PERFORMED FOR DIFFUSE AND BIFURCATION LESIONS IN THE LEFT CIRCUMFLEX ARTERIES. THE LESIONS WERE COMPLEX, AND THUS A TOTAL OF FOUR C-SES WERE IMPLANTED. FOUR BARE METAL STENTS (BMS) WERE ALSO USED DURING TREATMENT OF THE PATIENT, AND NONE EXHIBITED ANY SIGNIFICANT STRUCTURAL OR ANGIOGRAPHIC CHANGES DURING THE 9-YEAR FOLLOW-UP PERIOD. ON THE CONTRARY, POSITIVE REMODELING AND PROGRESSIVE PSS, WHICH WERE INDICATIVE OF STENT FRACTURE, WERE SEEN IN THE PROXIMAL STENT IN THE DIAGONAL BRANCH AT 1.5 YEARS. FOLLOW-UP CAG PERFORMED IN POSTOPERATIVE YEAR (POY) 5 DETECTED PROGRESSIVE PSS AND A NEW DISTAL STENT FRACTURE. FINALLY, ANEURYSMAL CHANGES WERE OBSERVED AT BOTH THE PROXIMAL AND DISTAL STENT FRACTURE SITES IN POY 9. PSS WAS FIRST SEEN IN THE C-SES IMPLANTED IN THE DISTAL SEGMENT OF THE LEFT CIRCUMFLEX ARTERY IN POY 5 AND THE LESION GRADUALLY ENLARGED UNTIL POY. THE MOST MARKED CHANGES OCCURRED IN THE BIFURCATION LESIONS IN THE LEFT CIRCUMFLEX ARTERY, WHICH WERE TREATED WITH FOUR C-SES, INCLUDING KISSING STENTS. BOTH OF THE KISSING STENTS FRACTURED. INTERESTINGLY, THE DISTANCES BETWEEN THE PAIRED EDGES OF THE TWO FRACTURED STENTS GRADUALLY INCREASED OVER TIME IN BOTH OF THE FRACTURED STENTS. ON THE OTHER HAND, INCREASES IN THE NUMBER AND SEVERITY OF PSS LESIONS, WHICH WERE MORE PROMINENT THAN THE OTHER LESIONS, WERE NOTED IN THE 5-YEAR FOLLOW-UP CAG. DURING THIS SERIES OF FOLLOW-UP STUDIES, IT WAS STRIKING THAT THE ANEURYSMAL CHANGES OCCURRED WHERE TWO STENTS CAME INTO CONTACT OR AT STENT FRACTURE SITES. FURTHER EVALUATIONS OF THE LEFT CIRCUMFLEX ARTERY USING TWO INTRAVASCULAR IMAGING DEVICES WERE PERFORMED IN POY 9. AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION REVEALED THE EXTENT OF POSITIVE REMODELING. FREQUENCY DOMAIN OPTICAL COHERENCE TOMOGRAPHY PROVIDED ADDITIONAL DETAILS, SUCH AS THE POSITIONAL RELATIONSHIP BETWEEN THE STENT AND THE ARTERIAL WALL AND THE DEGREE OF NEOINTIMAL PROLIFERATION ON THE STENT SURFACE, AND ALSO SHOWED INCOMPLETE STENT APPOSITION AND MULTIPLE INTERSTRUT HOLLOWS THAT COULD NOT BE DETECTED WITH CAG OR IVUS. AFTER THE FOLLOW-UP CAG IN POY 9, WE PROPOSED THE OPTION OF A CORONARY ARTERY BYPASS GRAFT, RATHER THAN MEDICAL FOLLOW-UP. THE PATIENT CHOSE TO RECEIVE SURGICAL TREATMENT AND UNDERWENT THE OPERATION 3 MONTHS LATER. SINCE HIS DISCHARGE, HE HAS REMAINED FREE FROM MAJOR ADVERSE CARDIOVASCULAR EVENTS WHILE TAKING ASPIRIN AND WARFARIN. THE PRODUCTS WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿STENT FRACTURED¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (LONG AND BIFURCATED LESIONS) MAY HAVE CONTRIBUTED TO THE FRACTURES. ACCORDING TO A REVIEW ARTICLE ¿STENTS ARE MORE LIKELY TO FRACTURE IN THE PRESENCE OF THE FOLLOWING FACTORS: BALLOON OR STENT OVEREXPANSION, AS IT MAY THEORETICALLY WEAKEN THE STENT STRUTS; STENT OVERLAP, WHICH RESULTS IN LOCALIZED RIGIDITY CREATING HINGE POINTS THAT DEFORM THE STENT LEADING TO FRACTURE; STENT LENGTH: LONGER STENTS MAY BE SUBJECTED TO HIGHER RADIAL FORCES; INAPPROPRIATE HANDLING OF STENT; STENTING TECHNIQUE: AN EXAMPLE OF STENTING TECHNIQUE THAT MIGHT CAUSE STENT FRACTURE IS CRUSH TECHNIQUE. A CASE HAS BEEN REPORTED OF STENT STRUT FRACTURE IN A BIFURCATION LESION TREATED WITH CRUSH STENTING, RESULTING IN RESTENOSIS. ANATOMIC AND PATHOLOGIC FACTORS WHICH INCLUDE THE FOLLOWING: TORTUOUS AND HIGHLY ANGULATED VESSEL; LONG LESIONS; CHANGE IN VESSEL ANGULATION AFTER STENT IMPLANTATION, WHICH CAN CREATE A SIGNIFICANT DISTORTION FORCE; COMPLEX LESIONS, AS IT WAS MORE FREQUENT IN THE COMPLEX LESION SUBSET OF CHRONIC TOTAL OCCLUSION; STENT LOCATION, AS IT IS MORE COMMON IN RIGHT CORONARY ARTERY (RCA) AND SAPHENOUS GRAFT LOCATIONS AS THESE VESSELS ARE DYNAMIC DURING CARDIAC CONTRACTIONS. STENTS IN THESE LOCATIONS MAY BE SUBJECTED TO REPETITIVE DISTORTING FORCES, AS SOME SEGMENTS OF THESE VESSELS HAVE MORE FLEXION POINTS DURING THE CARDIAC CYCLE. REPETITIVE CARDIAC CONTRACTION EXPOSES THE STENT TO COMPRESSION, TORSION, KINKING, ELONGATION, BENDING, AND SHEAR STRESS, WHICH CAN CAUSE FRACTURE FROM MECHANICAL FATIGUE. THE POINTS OF STENT FRACTURES ARE USUALLY LOCATED AT HINGES SUBJECTED TO EITHER MEDIAL OR SHEAR FORCES CREATED BY NON-UNIFORM VESSEL ANATOMY.¿ AS NO LOT NUMBER WAS SUPPLIED A DHR COULD NOT BE COMPLETED. ACCORDING TO THE PRECAUTIONS IN THE SAFETY INFORMATION PROVIDED IN THE INSTRUCTIONS FOR USE ¿SUBSEQUENT STENT BLOCKAGE MAY REQUIRE REPEAT DILATATION OF THE ARTERIAL SEGMENT CONTAINING THE STENT. THE LONG-TERM OUTCOME FOLLOWING REPEAT DILATATION OF ENDOTHELIALIZED STENTS IS NOT WELL CHARACTERIZED. TO AVOID THE POSSIBILITY OF DISSIMILAR METAL CORROSION, DO NOT IMPLANT STENTS OF DIFFERENT MATERIALS IN TANDEM WHERE OVERLAP OR CONTACT IS POSSIBLE.¿ ALSO ¿THE EXTENT OF THE PATIENT¿S EXPOSURE TO DRUG AND POLYMER IS DIRECTLY RELATED TO THE NUMBER OF STENTS IMPLANTED. USE OF MORE THAN TWO CYPHER STENTS HAS NOT RECEIVED ADEQUATE CLINICAL EVALUATION. USE OF MORE THAN TWO CYPHER STENTS WILL RESULT IN THE PATIENT RECEIVING LARGER AMOUNTS OF DRUG AND POLYMER THAN THE EXPERIENCE REFLECTED IN THE CLINICAL STUDIES.¿ THE INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    AS NOTED IN A LITERATURE PUBLICATION, NINE-YEAR FOLLOW-UP OF PROGRESSIVE PERI-STENT CONTRAST STAINING AFTER CYPHER SIROLIMUS-ELUTING STENT IMPLANTATION: A CASE REPORT; A (B)(6) MALE WAS REFERRED TO OUR HOSPITAL WITH A COMPLAINT OF REPETITIVE CHEST OPPRESSION AT REST. HE HAD NO HISTORY OF ALLERGIC DISEASES OR VASCULITIS, BUT WAS TAKING 10 MG OF NIFEDIPINE AND 100 MG OF CILOSTAZOL FOR HYPERTENSION AND SINUS BRADYCARDIA. ELECTROCARDIOGRAPHY AND ECHOCARDIOGRAPHY INDICATED MYOCARDIAL ISCHEMIA IN THE INFERIOR WALL. EMERGENCY CAG AND PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE RIGHT CORONARY ARTERY WERE PERFORMED (FIG. 1A, B). TRIPLE ANTIPLATELET THERAPY WITH 100 MG OF ASPIRIN, 200 MG OF TICLOPIDINE, AND 100 MG OF CILOSTAZOL WAS INITIATED. THREE DAYS LATER, HE UNDERWENT A STAGED PCI FOR THE LEFT ANTERIOR DESCENDING ARTERY (FIG. 1C, D). CYPHER_ SIROLIMUS-ELUTING STENTS (C-SES) WERE SELECTED BASED ON THE ASSUMPTION OF A HIGHER RESTENOSIS RATE OF LESIONS IN THE DIAGONAL BRANCH DUE TO THE SMALL SIZE OF THIS VESSEL COMPARED TO THE MAIN LEFT ANTERIOR DESCENDING ARTERY AND THE GREATER LENGTH OF THE ASSOCIATED LESIONS. ONE MONTH LATER, A SECOND ELECTIVE PCI WAS PERFORMED FOR DIFFUSE AND BIFURCATION LESIONS IN THE LEFT CIRCUMFLEX ARTERIES. THE LESIONS WERE COMPLEX, AND THUS A TOTAL OF FOUR C-SES WERE IMPLANTED (FIG. 1E). FOUR BARE METAL STENTS (BMS) WERE ALSO USED DURING TREATMENT OF THE PATIENT, AND NONE EXHIBITED ANY SIGNIFICANT STRUCTURAL OR ANGIOGRAPHIC CHANGES DURING THE 9-YEAR FOLLOW-UP PERIOD (FIG. 2A). ON THE CONTRARY, POSITIVE REMODELING AND PROGRESSIVE PSS, WHICH WERE INDICATIVE OF STENT FRACTURE, WERE SEEN IN THE PROXIMAL STENT IN THE DIAGONAL BRANCH AT 1.5 YEARS. FOLLOW-UP CAG PERFORMED IN POSTOPERATIVE YEAR (POY) 5 DETECTED PROGRESSIVE PSS AND A NEW DISTAL STENT FRACTURE. FINALLY, ANEURYSMAL CHANGES WERE OBSERVED AT BOTH THE PROXIMAL AND DISTAL STENT FRACTURE SITES IN POY 9 (FIG. 2B). PSS WAS FIRST SEEN IN THE C-SES IMPLANTED IN THE DISTAL SEGMENT OF THE LEFT CIRCUMFLEX ARTERY IN POY 5 AND THE LESION GRADUALLY ENLARGED UNTIL POY (FIG. 2C). THE MOST MARKED CHANGES OCCURRED IN THE BIFURCATION LESIONS IN THE LEFT CIRCUMFLEX ARTERY, WHICH WERE TREATED WITH FOUR C-SES, INCLUDING KISSING STENTS (FIG. 2D). BOTH OF THE KISSING STENTS FRACTURED. INTERESTINGLY, THE DISTANCES BETWEEN THE PAIRED EDGES OF THE TWO FRACTURED STENTS GRADUALLY INCREASED OVER TIME IN BOTH OF THE FRACTURED STENTS (FIG. 2D). ON THE OTHER HAND, INCREASES IN THE NUMBER AND SEVERITY OF PSS LESIONS, WHICH WERE MORE PROMINENT THAN THE OTHER LESIONS, WERE NOTED IN THE 5-YEAR FOLLOW-UP CAG. DURING THIS SERIES OF FOLLOW-UP STUDIES, IT WAS STRIKING THAT THE ANEURYSMAL CHANGES OCCURRED WHERE TWO STENTS CAME INTO CONTACT OR AT STENT FRACTURE SITES. FURTHER EVALUATIONS OF THE LEFT CIRCUMFLEX ARTERY USING TWO INTRAVASCULAR IMAGING DEVICES WERE PERFORMED IN POY 9. AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION REVEALED THE EXTENT OF POSITIVE REMODELING (FIG. 3). FREQUENCY DOMAIN OPTICAL COHERENCE TOMOGRAPHY (LUNAWAVE TM, TERUMO) PROVIDED ADDITIONAL DETAILS, SUCH AS THE POSITIONAL RELATIONSHIP BETWEEN THE STENT AND THE ARTERIAL WALL AND THE DEGREE OF NEOINTIMAL PROLIFERATION ON THE STENT SURFACE, AND ALSO SHOWED INCOMPLETE STENT APPOSITION AND MULTIPLE INTERSTRUT HOLLOWS THAT COULD NOT BE DETECTED WITH CAG OR IVUS (FIG. 4). AFTER THE FOLLOW-UP CAG IN POY 9, WE PROPOSED THE OPTION OF A CORONARY ARTERY BYPASS GRAFT, RATHER THAN MEDICAL FOLLOW-UP. THE PATIENT CHOSE TO RECEIVE SURGICAL TREATMENT AND UNDERWENT THE OPERATION 3 MONTHS LATER. SINCE HIS DISCHARGE, HE HAS REMAINED FREE FROM MAJOR ADVERSE CARDIOVASCULAR EVENTS WHILE TAKING ASPIRIN AND WARFARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635885 CYPHER BX JAPAN 2.50 X 28 MM CORONARY DRUG-ELUTING STENT NIQ CORDIS CASHEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R| S