BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083526 · Received July 23, 2008

    Report

    Report Number
    9616099-2008-01831
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    February 1, 2006
    Report Date
    June 26, 2008
    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

    ARTICLE "USE OF SAFECUT BALLOON FOR TREATMENT OF IN-STENT RESTENOSIS OF A PREVIOUSLY UNDEREXPANDED SIROLIMUS-ELUTING STENT WITH A HEAVILY CALCIFIED PLAQUE". PUBLISHED IN THE JOURNAL OF INVASIVE CARDIOLOGY VOL. 19, NO.7, JULY 2007 PP. E359-E362. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. A LITERATURE SEARCH REVEALED AN ARTICLE ENTITLED "USE OF SAFECUT BALLOON FOR TREATMENT OF IN-STENT RESTENOSIS OF A PREVIOUSLY UNDEREXPANDED SIROLIMUS-ELUTING STENT WAS A HEAVILY CALCIFIED PLAQUE". THE ARTICLE WAS PUBLISHED IN THE JOURNAL OF INVASIVE CARDIOLOGY. A MALE EXPERIENCED IN-STENT RESTENOSIS APPROXIMATELY 18 MONTHS POST IMPLANTATION OF TWO CYPHER STENTS. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERTENSION, INSULIN DEPENDENT DIABETES, AND SILENT MYOCARDIAL ISCHEMIA. CORONARY ANGIOGRAPHY REVEALED A LONG, DIFFUSE 75% STENOSIS WAS HEAVY CALCIFICATION IN THE MID LAD. PRE-DILATION OF THE LESION WAS ATTEMPTED WITH A NON-CORDIS BALLOON BUT THE BALLOON RUPTURED. ROTATIONAL ATHERECTOMY WAS PERFORMED WITH A ROTABLATOR FOLLOWED BY BALLOON DILATION WITH UNSATISFACTORY RESULTS. A 3.0X28MM CYPHER WAS IMPLANTED IN THE DISTAL LAD AND A 3.0X13MM CYPHER WAS IMPLANTED IN THE PROXIMAL LAD OVERLAPPING THE FIRST STENT. A PORTION OF THE PROXIMAL CYPHER STENT COULD NOT BE FULLY EXPANDED. AT ONE-YEAR FOLLOW UP, THE PATIENT HAD NO ISCHEMIA. A YEAR AND A HALF AFTER THE INDEX PROCEDURE, SILENT ISCHEMIA WAS CONFIRMED BY AN EXERCISE TEST. CORONARY ANGIOGRAPHY REVEALED 90% FOCAL IN-STENT RESTENOSIS IN THE UNDEREXPANDED 3.0X13MM CYPHER STENT. A SAFECUT BALLOON WAS USED AND FULL BALLOON EXPANSION WAS ACHIEVED WITH SATISFACTORY RESULTS. IVUS SHOWED A MARKED IMPROVEMENT IN LUMINAL AREA WITH SUFFICIENT STENT EXPANSION. AT SIX-MONTHS FOLLOW-UP, THE PATIENT HAD NO ISCHEMIA. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, REVIEW OF THE MANUFACTURING RECORDS (DHR) COULD NOT BE PERFORMED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. CALCIFIED LESIONS ARE A CAUSE OF STENT UNDEREXPANSION WHICH SIGNIFICANTLY INCREASES THE SUBSEQUENT RUSKS OF IN-STENT RESTENOSIS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS (SPECIFICALLY DIABETES), VESSEL/LESION FACTORS (HEAVILY CALCIFIED AND LONG LESION) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2008-01830 AND #9616099-2008-01831. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    A LITERATURE SEARCH OBTAINED AN ARTICLE ENTITLED "USE OF SAFECUT BALLOON FOR TREATMENT OF IN-STENT RESTENOSIS OF A PREVIOUSLY UNDEREXPANDED SIROLIMUS-ELUTING STENT WITH A HEAVILY CALCIFIED PLAQUE". ONE AND ONE-HALF YEARS AFTER IMPLANTATION OF TWO CYPHER STENTS IN THE PROXIMAL/DISTAL LEFT ANTERIOR DESCENDING (LAD) TARGET LESION, THE PATIENT'S STENTS WERE FOUND TO BE UNDER-EXPANDED AND A FOCAL 90% IN-STENT RESTENOSIS (ISR) WAS REPORTED. A CYPHER 3.0 X 28 MM STENT WAS IMPLANTED IN DISTAL LAD AND A 3.0 X 13 MM STENT WAS IMPLANTED IN THE PROXIMAL LAD IN OVERLAPPING FASHION. THE RESTENOTIC LESION WAS DILATED WITH A 3.0 X 15 MM SAFECUT BALLOON AT 18 ATM. IVUS WAS DONE. A SATISFACTORY RESULT WAS OBTAINED. THE PATIENT WAS ASYMPTOMATIC SIX MONTHS AFTER THE RE-INTERVENTION.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R ROTATIONAL ATHRECTOMY USING A ROTAWIRE| 2.75 X 12 MM APOLLO BALLOON| 2.5 X 30 MM MAVERICK BALLOON| 8 FR. JL4 GUIDING CATHETER| UNICORE GUIDEWIRE| 1.75 MM AND 2.15 MM BURRS