BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1180173 · Received September 29, 2008

    Report

    Report Number
    9616099-2008-02360
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    May 12, 2008
    Report Date
    September 2, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. HOWEVER, A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESS THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED TO THE COATING SITE FOR CORONARY ARTERY RESTENOSIS. THE INVESTIGATION REVEALED THAT NO NONCONFORMANCES WERE ISSUED DURING THE COATING PROCESS, AND THAT NO ANOMALIES WERE FOUND FOR THE LOT INVOLVED. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING NUMBER: 9616099-2008-02361. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY THREE YEARS POST STENT IMPLANT, IN-STENT RESTENOSIS WAS IDENTIFIED. THIS COMPLAINT IS FROM THE CLINICAL STUDY. THE REPORT RECEIVED INDICATED THAT THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE PROCEDURE INCLUDED TREATMENT OF THE LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD). THE VESSEL WAS AN IN-STENT RESTENOSIS OF THE COMPETITOR'S BARE METAL STENT. THE VESSEL WAS SLIGHTLY CALCIFIED AND PRESENTED A REFERENCE DIAMETER OF 2.18MM AND TIMI 0. THE LESION PRESENTED 100% STENOSIS AND WAS CLASSIFIED AS A TYPE C. DURING THE PROCEDURE, FEMORAL APPROACH WAS CHOSEN AND THE LESION WAS PREDILATED TO 16 ATMOSPHERES (ATMS). THEN ONE 2.5X18MM CYPHER STENT WAS IMPLANTED AT 16 ATM FOR 16 TO APPROX 30 SECONDS, AT THE PROXIMAL END, OVERLAPPING THE STENT A 3.0X18MM CYPHER STENT WAS IMPLANTED AT 20 ATM FOR 16 TO APPROX 30SECONDS. POST PROCEDURE, THE LESION PRESENTED 6% RESIDUAL STENOSIS AND TIMI III. THERE WERE NO DIFFICULTIES OR PROBLEMS DURING THE PROCEDURE. TWO YEARS AND FOUR MONTHS POST INDEX PROCEDURE, THE PATIENT COMPLAINED OF BREATHING DIFFICULTY. A CORONARY ANGIOGRAM (CAG) WAS CONDUCTED AND A NEW LESION IN THE DISTAL LAD WAS IDENTIFIED; THE CYPHER IMPLANTED AT THE MID LAD WAS PATENT. THE NEW LESION WAS TREATED WITH BALLOON ANGIOPLASTY. THREE YEARS POST INDEX PROCEDURE, A FOLLOW UP CAG WAS CONDUCTED. A 100% STENOSIS IN THE INSIDE OF THE DISTALLY IMPLANTED CYPHER WAS OBSERVED. THE EXACT PORTION WHERE THE RESTENOSIS OCCURRED WAS UNKNOWN. THE RESTENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY; THE RESIDUAL STENOSIS WAS 50%. THERE WAS NO DETAILED INFORMATION AVAILABLE REGARDING THE PROCEDURE. THE PHYSICIAN'S COMMENT INDICATED THAT "THE PATIENT EASILY CAN GET CARDIAC STENOSIS, AND SO IT IS NOT RELATED CYPHER'S PRODUCT DEFECT." THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. HOWEVER, A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESS THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED TO THE COATING SITE FOR CORONARY ARTERY RESTENOSIS. THE INVESTIGATION REVEALED THAT NO NONCONFORMANCES WERE ISSUED DURING THE COATING PROCESS, AND THAT NO ANOMALIES WERE FOUND FOR THE LOT INVOLVED. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING NUMBER: 9616099-2008-02361. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA I0205160

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R HEPARIN| 1.5X15MM PRE-DILATION BALLOON| DILTIAZEM HYDROCHLORIDE| NICORANDIL| TICLOPIDINE| ASPIRIN| ISOSORBIDE DINITRATE| AMLODIPINE BESILATE| NITROGLYCERIN