BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2013250 · Received March 10, 2011

    Report

    Report Number
    9616099-2011-00166
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE BALLOON OF A CYPHER SDS RUPTURED WHILE USED TO POST-DILATE THE ALREADY DEPLOYED CYPHER STENT. THERE WAS NO PATIENT INJURY REPORTED. PCI WAS BEING PERFORMED ON A 99% OCCLUDED LESION IN THE PROXIMAL TO DISTAL RCA. IT IS UNKNOWN IF THE LESION WAS A DE-NOVO BUT WAS HIGHLY TORTUOUS. THE SAFETY AND EFFECTIVENESS OF CYPHER HAS NOT BEEN ESTABLISHED IN PATIENTS WITH TORTUOUS VESSELS THAT MAY IMPAIR STENT PLACEMENT IN THE REGION OF OBSTRUCTION OR PROXIMAL TO THE LESION. RADIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. A RUNTHROUGH GUIDEWIRE CROSSED THE LESION AND IVUS WAS DELIVERED, BUT THE IVUS WOULD NOT CROSS THE LESION DUE TO THE CALCIFICATION. PRE-DILATION WAS CONDUCTED WITH A 2.0X15MM LACROSSE BALLOON CATHETER AND THEN IVUS COULD BE CONDUCTED. THEN, THE 1ST CYPHER SELECT +, A 2.5X28MM AND THE 2ND CYPHER SELECT + , A 3.0X28MM (COMPLAINT PRODUCT) WERE IMPLANTED IN THE MID TO DISTAL RCA. WHEN POST-DILATION WAS CONDUCTED WITH THE SDS OF THE 2ND CYPHER SELECT+, THE BALLOON RUPTURED AT 18~20ATM ON THE FIRST TRY. BALLOON RUPTURE WAS CONFIRMED BY DECREASING PRESSURE OF THE INFLATION DEVICE. THEREFORE, THE SDS OF THE 2ND CYPHER SELECT+ WAS RETRIEVED FROM THE PATIENT WITHOUT DIFFICULTY AND INTACT. AFTERWARDS, THE 3RD CYPHER SELECT + (3.0X18MM) WAS IMPLANTED IN THE PROXIMAL RCA. POST-DILATION AND IVUS WERE CONDUCTED AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THE DEVICE PREPPED NORMALLY. THE BRAND OF CONTRAST MEDIA AND INDEFLATOR USED AS WELL AS THE CONTRAST TO SALINE RATIO WERE UNKNOWN. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE SDS WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE PATIENT'S INFECTIOUS DISEASE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. THE PRECAUTIONS FOR USE IN THE IFU STATE THAT BALLOON PRESSURES SHOULD BE MONITORED DURING INFLATION AND THAT EXCEEDING THE RECOMMENDED RATED BURST PRESSURE (RBP) AS INDICATED ON THE PRODUCT LABEL MAY RESULT IN A RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. WITH THE INFORMATION AVAILABLE FOR REVIEW, AND NO PRODUCT RETURN, THE COMPLAINT COULD NOT BE CONFIRMED AND NO SPECIFIC ROOT CAUSE COULD BE IDENTIFIED THAT CAN BE ATTRIBUTED TO EITHER THE PRODUCT DESIGN, RAW MATERIALS USED OR THE MANUFACTURING PROCESS. THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE POSSIBLE VESSEL CHARACTERISTICS (CALCIFICATION AND TORTUOSITY) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT BELONGS TO THE SAME CLASS OF DEVICES AS THE US DISTRIBUTED CYPHER SIROLIMUS DRUG-ELUTING STENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT DEVICES: GW: RUNTHROUGH, GC: LAUNCHER AL1 SH, BC: LACROSSE 2.0/15MM, STENT: CYPHER SELECT+ 2.5/28MM, 3.0/18MM.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT PCI WAS BEING PERFORMED ON A 99% OCCLUDED LESION IN THE PROXIMAL TO DISTAL RCA. IT IS UNKNOWN IF THE LESION WAS A DE-NOVO OR CALCIFIED, BUT WAS HIGHLY TORTUOUS. RADIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. A RUNTHROUGH GUIDEWIRE CROSSED THE LESION AND IVUS WAS DELIVERED, BUT THE IVUS WOULD NOT CROSS THE LESION DUE TO THE CALCIFICATION. PRE-DILATION WAS CONDUCTED WITH A 2.0X15MM LACROSSE BALLOON CATHETER AND THEN IVUS COULD BE CONDUCTED. THEN, THE 1ST CYPHER SELECT+, A 2.5X28MM AND THE 2ND CYPHER SELECT+ (3.0X28MM: COMPLAINT PRODUCT) WERE IMPLANTED IN THE MID TO DISTAL RCA. WHEN POST-DILATION WAS CONDUCTED WITH THE SDS OF THE 2ND CYPHER SELECT+, THE BALLOON RUPTURED AT 18-20ATM ON THE FIRST TRY. BALLOON RUPTURE WAS CONFIRMED BY DECREASING PRESSURE OF THE INFLATION DEVICE. THEREFORE, THE SDS OF THE 2ND CYPHER SELECT+ WAS RETRIEVED FROM THE PATIENT. AFTERWARDS, THE 3RD CYPHER SELECT+ (3.0X18MM) WAS IMPLANTED IN THE PROXIMAL RCA. POST-DILATION AND IVUS WERE CONDUCTED AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE SDS WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE PATIENT'S INFECTIOUS DISEASE. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THE DEVICE PREPPED NORMALLY. THE BRAND OF CONTRAST MEDIA AND INDEFLATOR USED AS WELL AS THE CONTRAST TO SALINE RATIO WERE UNKNOWN. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE BUT IT WAS NOT INDICATED IF THERE WAS ANY RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. IT WAS REMOVED EASILY AND INTACT UPON REMOVAL FROM THE PATIENT.

    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 15232129

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention