BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1778474 · Received July 31, 2010

    Report

    Report Number
    9616099-2010-00578
    Event Type
    Malfunction
    Date Received
    July 31, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 30, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CYPHER SELECT PLUS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER IT IS SIMILAR TO THE CYPHER SIROLIMUS-ELUTING CORONARY STENT PRODUCT DISTRIBUTED IN THE UNITED STATES. DURING A PCI, A DISSECTION OCCURRED POST DEPLOYMENT OF A CYPHER STENT AND THERE WAS DIFFICULTY ADVANCING ANOTHER CYPHER PRODUCT THROUGH THE PREVIOUSLY IMPLANTED STENT. THE TARGET LESION WAS THE OSTIUM OF PROXIMAL CIRCUMFLEX TO THE DISTAL CIRCUMFLEX. THE LESION WAS A DE NOVO, DIFFUSED, HEAVILY CALCIFIED AND MODERATELY 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. THERE WAS 90% STENOSIS. PRE-DILATION WAS THOROUGHLY CONDUCTED BEFORE THE 1ST PRODUCT, 3.0X33MM CYPHER SELECT+ (LOT NUMBER UNKNOWN) WAS IMPLANTED AT THE DISTAL END OF THE TARGET LESION FOLLOWED BY A SECOND 3.0X33MM CYPHER SELECT+ (LOT # 15138918) IMPLANTED PROXIMAL TO THE 1ST CYPHER AND OVERLAPPING IT. DURING IMPLANTATION OF THE 2ND CYPHER, A DISSECTION OCCURRED AT THE DISTAL END OF THE 2ND CYPHER. THE TYPE OF DISSECTION WAS UNKNOWN. IT WAS UNKNOWN IF THE DISSECTION WAS FLOW-LIMITING. TO TREAT THE DISSECTION, A 2.5X13MM CYPHER SELECT+ WAS INSERTED BUT IT BECAME CAUGHT AT THE DISTAL END OF THE 2ND IMPLANTED CYPHER SELECT+ AND IT COULD NOT BE DELIVERED. THE PRODUCT WAS REMOVED AND A BALLOON (3.0/12MM, BRAND UNKNOWN) WAS DELIVERED TO THE TARGET LESION, BUT THE BALLOON BECAME CAUGHT AT THE SAME PORTION WHILE ADVANCING IT. THEREFORE POST-DILATION WAS CONDUCTED WITH A SMALLER BALLOON (2.5/10MM) FIRST AND THEN WITH THE ORIGINAL BALLOON (3.0/12MM) AGAIN, ALTHOUGH THERE WAS FRICTION NOTED WHILE DELIVERING THROUGH THE DISTAL END OF THE 2ND CYPHER SELECT+. AFTER POST-DILATION THE 3RD CYPHER, 2.5X13MM CYPHER SELECT +, WAS RE-DELIVERED TO THE TARGET LESION BUT IT BECAME CAUGHT ON THE STRUT OF THE 2ND CYPHER SELECT+ (SAME SECTION) AGAIN. THEREFORE THE PHYSICIAN STOPPED USING THE 3RD CYPHER, AND THE PROCEDURE WAS FINISHED WITH POBA ONLY. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (15138918) PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. IN THE PRECAUTIONS SECTION OF THE IFU IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THIS IS AN INHERENT RISK OF THE PROCEDURE. THE RELATIONSHIP BETWEEN THE FAILURE TO CROSS OR TRACK A PRODUCT AND THE PRODUCT ITSELF IS NOT CLEAR, BUT FACTORS SUCH AS TORTUOUS VESSELS, CALCIFIED LESIONS OR AN INCREASED DIFFICULTY TO TRACK THE PRODUCT THROUGH AN EXISTING STENT MAY CONTRIBUTE TO IT. THE PHYSICIAN COMMENTED THAT THE STENT STRUTS OF THE 3RD CYPHER BECOME CAUGHT WITH THE 2ND CYPHER SELECT WHILE ADVANCING IT BECAUSE IT'S POSSIBLE THAT THE 2ND CYPHER SELECT+ WAS FLARED AT THE DISTAL END OF THE STENT DUE TO THE CALCIFICATION. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (CALCIFIED AND MODERATELY TORTUOUS) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS.

    Description of Event or Problem · 1

    DURING THE PROCEDURE PRE-DILATION WAS THOROUGHLY CONDUCTED AND THEN 1ST 3.0 X 33MM CYPHER SELECT+ WAS IMPLANTED FROM THE DISTAL END OF THE OSTIUM OF THE PROXIMAL TO DISTAL CIRCUMFLEX. A 2ND 3.0 X 33MM CYPHER SELECT+ WAS IMPLANTED PROXIMAL TO THE 1ST IMPLANTED CYPHER AT THE DISTAL END OF THE TARGET LESION. DURING IMPLANTING THE 2ND CYPHER SELECT+, DISSECTION OCCURRED AT THE DISTAL END OF THE 2ND CYPHER SELECT+. THE 1ST AND 2ND STENT WERE OVERLAPPING AT THIS TIME. TO BAIL THE PATIENT OUT, 3RD CYPHER SELECT+ 2.5 X 13MM WAS BEING IMPLANTED AT THE TARGET LESION, BUT THE 3RD CYPHER SELECT+ BECAME CAUGHT ON THE DISTAL END OF THE 2ND IMPLANTED CYPHER SELECT+ AND IT COULD NOT BE DELIVERED. THEREFORE A 3.0 X 12MM BALLOON WAS DELIVERED TO THE TARGET LESION, BUT THE BALLOON BECAME CAUGHT AT THE SAME PORTION WHILE ADVANCING IT. THEREFORE POST-DILATION WAS CONDUCTED WITH A SMALLER BALLOON 2.5 X 10MM AND POST-DILATION WAS CONDUCTED WITH THE BALLOON 3.0 X 12MM AGAIN ALTHOUGH THERE WAS FRICTION AT THE DISTAL END OF THE 2ND CYPHER SELECT+ DURING THE DELIVERY. AND THEN THE PHYSICIAN TRIED TO REDELIVER THE 3RD CYPHER TO THE TARGET LESION BUT THE CYPHER SELECT+ BECAME CAUGHT ON THE STRUT OF THE 2ND CYPHER SELECT+ (SAME SECTION) AGAIN. THEREFORE THE PHYSICIAN STOPPED USING THE 3RD CYPHER, AND THE PROCEDURE WAS FINISHED WITH POBA ONLY. THE PHYSICIAN INDICATED THAT THE STENT STRUTS OF THE 3RD CYPHER BECOME CAUGHT WITH THE 2ND CYPHER SELECT WHILE ADVANCING IT BECAUSE IT'S POSSIBLE THAT THE 2ND CYPHER SELECT+ WAS FLARED AT THE DISTAL END OF THE STENT DUE TO THE CALCIFICATION. THERE WAS PATIENT INJURY REPORTED DUE TO THE CYPHER SELECT IMPLANT. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE OR DURING THE PROCEDURE. THE TARGET LESION WAS THE OSTIUM OF THE PROXIMAL TO DISTAL CIRCUMFLEX. THE LESION WAS A DE NOVO, DIFFUSED, HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THERE WAS 90% STENOSIS. THE PRODUCT PREPPED ACCORDING TO IFU.

    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 15138918

    Patients

    Seq Age Sex Outcome Treatment
    1