BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 912407 · Received September 13, 2007

    Report

    Report Number
    9616099-2007-01826
    Event Type
    Injury
    Date Received
    September 13, 2007
    Date of Event
    February 9, 2006
    Report Date
    August 21, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDEX PROCEDURE (CLINICAL STUDY) WAS AN ELECTIVE CASE DONE VIA THE FEMORAL APPROACH. THE TARGET LESION WAS THE PROXIMAL LAD. THE LESION WAS REPORTED TO BE: DE NOVO, CONCENTRIC, DIFFUSELY DISEASED, MODERATELY CALCIFIED, NOT TORTUOUS, 3.0 MM VESSEL DIAMETER, 48 MM IN LENGTH, A CHRONIC TOTAL OCCLUSION (CTO)/100% STENOSED, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.0 X 20 MM BALLOON AT 16 ATM/DURATION UNKNOWN. THREE (3) CYPHER STENTS WERE IMPLANTED IN OVERLAPPING FASHION: A 3.0 X 18 MM STENT (STENT #1) WAS IMPLANTED AT 20 ATM/16-30 SEC., A 3.0 X 23 MM STENT (STENT #2) DISTAL TO STENT #1 WAS IMPLANTED AT 12 ATM/16-30 SEC., AND ANOTHER 3.0 X 23 (STENT#3) WAS IMPLANTED AT 16 ATM/16-30 SEC. DISTAL TO STENT #2. THE STENTS WERE NOT POST-DILATED. THE FLOW PRE-PROCEDURE WAS TIMI 0 AND POST-PROCEDURE TIMI 3. THE RESIDUAL STENOSIS WAS 16.1% IVUS WAS NOT DONE. APPROX. EIGHT (8) MONTHS AFTER THE INDEX PROCEDURE, NEW, DE NOVO LESIONS IN THE LEFT MAIN TRUNK (LMT) AND PROXIMAL CIRCUMFLEX (CX) FOUND DURING FOLLOW-UP CORONARY ANGIOGRAPHY WERE TREATED BY IMPLANTATION OF THREE ADDITIONAL CYPHER STENTS. THE STENTS IMPLANTED PREVIOUSLY IN THE PROXIMAL LAD WERE NOTED TO BE PATENT. THE LESION WAS TREATED THREE (3) WEEKS LATER. LESION #2: THE TARGET LESION WAS THE LMT. THE LESION WAS REPORTED TO BE A 75% STENOSIS. THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON AT 20 ATM/7 SEC. A CYPHER 3.5 X 18 MM (STENT #4) WAS IMPLANTED AT 22 ATM/8 SEC. PROXIMAL TO AND OVERLAPPING CYPHER STENT #1 IN THE PROXIMAL LAD. THE LESION WAS NOT POST-DILATED. LESION #3: THE TARGET LESION WAS THE PROXIMAL CX. THE LESION WAS REPORTED TO BE A 75% STENOSIS. THE LESION WAS PRE-DILATED WITH A 2.5 X 12 MM BALLOON AT 22 ATM/8 SEC. A CYPHER 2.5 X 23 MM (STENT #5) WAS IMPLANTED AT 22 ATM/8 SEC. PROXIMALLY. AN ADDITIONAL CYPHER 2.5 X 18 MM (STENT #6) WAS IMPLANTED AT 22 ATM/8 SEC. DISTALLY IN OVERLAPPING FASHION. THE STENTS WERE NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. APPROX. FIFTEEN (15) MONTHS AFTER THE INDEX PROCEDURE THE PATIENT COMPLAINED OF CHEST PAIN. APPROX SIXTEEN MONTHS AFTER THE INDEX PROCEDURE, CORONARY ANGIOGRAPHY WAS DONE AND A 60% RESTENOSIS OF THE OSTIAL/PROXIMAL CX WAS OBSERVED AND TREATED BY IMPLANTATION OF A CYPHER 3.5 X 18 MM STENT (STENT #7) AS DESCRIBED PREVIOUSLY (SEC. B5). DURING THIS SAME PROCEDURE, THE DISTAL RIGHT CORONARY ARTERY (RCA) WAS TREATED (LESION #4). THE LESION WAS A CTO/100% OCCLUSION. THE LESION WAS PRE-DILATED WITH A 3.25 X 15 MM BALLOON AT 16 ATM/DURATION UNKNOWN. TWO (2) CYPHER 3.5 X 23 MM STENTS (STENTS #8 AND #9) AND A CYPHER 3.0 X 30 MM WERE IMPLANTED-ATM/DURATION UNKNOWN IN OVERLAPPING FASHION. THE STENTS WERE NOT POST-DILATED. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS IS NOT ONE OF THE DEVICES IN THE CLINICAL STUDY. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TEN PRODUCTS USED FOR THE SAME PATIENT. PLEASE REFERENCE MFR. REPORT # 9616099-2007-01825 AND # 9616099-2007-01826.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT WAS INCLUDED IN A CLINICAL STUDY, A TOTAL OF THREE (3) CYPHER STENTS WERE IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) TARGET LESION IN OVERLAPPING FASHION: TWO (2) 3.0X23MM STENTS AND A 3.0X18MM STENT. THESE THREE (3) STENTS ARE THE ONLY ONES INCLUDED IN THE STUDY. APPROX. EIGHT (8) MONTHS AFTER THE INDEX PROCEDURE, NEW, DE NOVO LESIONS IN THE MAIN TRUNK (LMT) AND PROXIMAL CIRCUMFLEX (CX) FOUND DURING FOLLOW-UP CORONARY ANGIOGRAPHY WERE TREATED BY IMPLANTATION OF THREE ADDITIONAL CYPHER STENTS: A 3.5X18MM (STENT #4) IN THE LMT, AND A 2.5X23MM STENT (STENT #5) AND A 2.5X18MM (STENT #6) OVERLAPPING IN THE CX. APPROX. FIFTEEN (15) MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN. APPROX. SIXTEEN MONTHS AFTER THE INDEX PROCEDURE, CORONARY ANGIOGRAPHY WAS DONE AND A 60% RESTENOSIS OF THE OSTIAL/PROXIMAL CX WAS OBSERVED. THIS RESTENOTIC LESION WAS WITHIN FIVE (5) MM (PERI-STENT RESTENOSIS) OF THE CYPHER 3.0X23MM STENT IMPLANTED DURING THE INDEX PROCEDURE/CLINICAL STUDY (STENT #2) AND THE CYPHER 2.5X23MM STENT (STENT #5) IMPLANTED EIGHT (8) MONTHS AFTER THE INDEX PROCEDURE. THE RESTENOTIC LESION WAS PRE-DILATED WITH A 2.5X15MM BALLOON AT 16 ATM/DURATION UNKNOWN. A CYPHER 3.5X18MM STENT (STENT #7) WAS IMPLANTED AT 20 ATM/19 SEC. IN OVERLAPPING FASHION WITH STENT #5. THE STENT WAS POST-DILATED WITH A 3.5X15MM BALLOON AT 12 ATM USING A KISSING BALLOON TECHNIQUE (KBT) WITH THE LAD. THE RESIDUAL STENOSIS WAS 23%. THE PHYSICIAN'S COMMENT REGARDING THE EVENT IS THAT THE PATIENT CAN GET CARDIAC STENOSIS EASILY, BUT THE EXACT CAUSE IS UNKNOWN.

    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 I0405020

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 2.5X15MM BALLOON