BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER DRUG ELUTING STENT

    MDR report key: 6405368 · Received March 15, 2017

    Report

    Report Number
    9616099-2017-00969
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    June 1, 2016
    Report Date
    March 15, 2017
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS:  MOROFUJI ET AL HETEROGENEOUS INTRAVASCULAR ULTRASOUND FINDINGS OF STENT THROMBOSIS, INTERN MED (2016) 56 (3): 259-268.  A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT.  THE DEVICE BEGINNING WITH CATALOG NUMBER CJS WAS NOT SOLD IN THE US BUT WAS SIMILAR TO THE CYPHER CATALOG  NUMBERS CXS. AS NOTED IN THE PUBLICATION BY MOROFUJI ET AL HETEROGENEOUS INTRAVASCULAR ULTRASOUND FINDINGS OF STENT THROMBOSIS, INTERN MED (2016) 56 (3): 259-268; AN (B)(6) MAN WAS INITIALLY IMPLANTED WITH A 3.0×28-MM SES IN THE MID-LAD FOR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. A SECOND PROCEDURE WAS PERFORMED SIX MONTHS AFTER THE INDEX SIROLIMUS ELUTING STENT (SES) PLACEMENT BECAUSE OF LESION PROGRESSION AT THE STENT PROXIMAL SITE. IN THE SECOND PROCEDURE, THE PATIENT WAS IMPLANTED WITH A 3.0×18-MM SES, WHICH OVERLAPPED THE OLD STENT. AT 67.6 MONTHS AFTER THE FIRST PROCEDURE, THE PATIENT WAS ADMITTED TO OUR HOSPITAL BECAUSE OF SUSTAINED CHEST PAIN. EMERGENCY CORONARY ANGIOGRAPHY REVEALED OBVIOUS STENT FRACTURE AT THE SITE OF TOTAL OCCLUSION NEAR THE OVERLAPPING SITE. IVUS WAS PERFORMED AFTER THROMBUS ASPIRATION AND BALLOON ANGIOPLASTY, CONFIRMING COMPLETE SEPARATE STENT FRACTURE WITH DISPLACEMENT. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS.  NO LOT NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE GENERATED.  THE REPORTED ¿STENT FRACTURED - IN PATIENT¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN. AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A DHR COULD NOT BE COMPLETED. ACCORDING TO 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. RESTENOSIS OF STENTED SEGMENT (GREATER THAN 50% OBSTRUCTION). 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.¿ IT IS KNOWN THAT OVERLAPPED STENTS ARE MORE AT RISK OF FRACTURE DUE TO INCREASED STRESSES ACTING UPON THE STENTS. THE LIMITED 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. PLEASE NOTE THAT THIS IS ONE OF TWO REPORTS ASSOCIATED WITH THIS PATIENT BUT THE SECOND MANUFACTURING REPORT IS NOT YET AVAILABLE.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY MOROFUJI ET AL HETEROGENEOUS INTRAVASCULAR ULTRASOUND FINDINGS OF STENT THROMBOSIS, INTERN MED (2016) 56 (3): 259-268; AN (B)(6) MAN WAS INITIALLY IMPLANTED WITH A 3.0×28-MM SES IN THE MID-LAD FOR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. A SECOND PROCEDURE WAS PERFORMED SIX MONTHS AFTER THE INDEX SIROLIMUS ELUTING STENT (SES) PLACEMENT BECAUSE OF LESION PROGRESSION AT THE STENT PROXIMAL SITE. IN THE SECOND PROCEDURE, THE PATIENT WAS IMPLANTED WITH A 3.0×18-MM SES, WHICH OVERLAPPED THE OLD STENT. AT 67.6 MONTHS AFTER THE FIRST PROCEDURE, THE PATIENT WAS ADMITTED TO OUR HOSPITAL BECAUSE OF SUSTAINED CHEST PAIN. EMERGENCY CORONARY ANGIOGRAPHY REVEALED OBVIOUS STENT FRACTURE AT THE SITE OF TOTAL OCCLUSION NEAR THE OVERLAPPING SITE. IVUS WAS PERFORMED AFTER THROMBUS ASPIRATION AND BALLOON ANGIOPLASTY, CONFIRMING COMPLETE SEPARATE STENT FRACTURE WITH DISPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189977 CYPHER DRUG ELUTING STENT DRUG ELUTING STENT NIQ CORDIS DE MEXICO N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 Hospitalization| L| R