BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CYPHER JAPAN

    MDR report key: 7267041 · Received February 13, 2018

    Report

    Report Number
    9616099-2018-01855
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    August 31, 2017
    Report Date
    February 13, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    NIQ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLEASE NOTE THAT THERE IS NO PATIENT PROBLEM CODE AVAILABLE FOR PERI-STENT CONTRAST STAINING AND NO CODE AVAILABLE WAS SELECTED. THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS A JAPAN CYPHER STENT BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THIS DEVICE WAS NOT SOLD IN THE US BUT WAS SIMILAR TO THE CYPHER STENT SOLD IN THE US. THE CITATION IS AS FOLLOWS: FUKU ET AL IMPACT OF DUAL ANTIPLATELET THERAPY BEYOND 1 YEAR ON CLINICAL OUTCOMES OF PATIENTS WITH STENT FRACTURE OR PERI-STENT CONTRAST STAINING AFTER SIROLIMUS-ELUTING STENT IMPLANTATION; CIRC J. 2017 DEC 25;82(1):211-217. AS NOTED IN THE PUBLICATION FUKU ET AL IMPACT OF DUAL ANTIPLATELET THERAPY BEYOND 1 YEAR ON CLINICAL OUTCOMES OF PATIENTS WITH STENT FRACTURE OR PERI-STENT CONTRAST STAINING AFTER SIROLIMUS-ELUTING STENT IMPLANTATION; CIRC J. 2017 DEC 25;82(1):211-217; REPORT THAT A PATIENT TREATED WITH A SIROLIMUS STENT IN THE PROXIMAL LAD HAD VERY LATE STENT THROMBOSIS (VLST) 37 MONTHS AFTER PCI, PERI-STENT CONTRAST STAINING (PSS) AND STENT FRACTURE. THE PATIENT WAS OFF THIENOPYRIDINE AT 1 YEAR AND AT THE ONSET OF THE VLST AS WELL AS OFF ASPIRIN AT THE ONSET OF VLST. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿STENT FRACTURED - IN PATIENT¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN. THE ARTICLE PROVIDED IVUS (INTRAVASCULAR ULTRASOUND) IMAGES WHICH INDICATED MALPOSITIONED STENT STRUTS; HOWEVER IT COULD NOT BE DETERMINED WHETHER THE STENT STRUTS WERE FRACTURED. ACCORDING TO THE SAFETY INFORMATION PROVIDED IN THE INSTRUCTIONS FOR USE ¿WHILE NOT OBSERVED IN PIVOTAL CLINICAL TRIALS THAT SUPPORTED THE CYPHER® STENT DESIGN DOSSIER, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY, AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. THE CLINICAL IMPLICATIONS OF STENT FRACTURE ARE NOT WELL CHARACTERIZED.¿ 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 PHR COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION FUKU ET AL IMPACT OF DUAL ANTIPLATELET THERAPY BEYOND 1 YEAR ON CLINICAL OUTCOMES OF PATIENTS WITH STENT FRACTURE OR PERI-STENT CONTRAST STAINING AFTER SIROLIMUS-ELUTING STENT IMPLANTATION; CIRC J. 2017 DEC 25;82(1):211-217; REPORT THAT A PATIENT TREATED WITH A SIROLIMUS STENT IN THE PROXIMAL LAD HAD VERY LATE STENT THROMBOSIS (VLST) 37 MONTHS AFTER PCI, PERI-STENT CONTRAST STAINING (PSS) AND STENT FRACTURE. THE PATIENT WAS OFF THIENOPYRIDINE AT 1 YEAR AND AT THE ONSET OF THE VLST AS WELL AS OFF ASPIRIN AT THE ONSET OF VLST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112038 UNKNOWN CYPHER JAPAN DRUG ELUTING STENT NIQ CORDIS CASHEL N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 Hospitalization| L| R