BEUDAMED
    FDA Adverse Event Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2192581 · Received August 5, 2011

    Report

    Report Number
    9616099-2011-00580
    Date Received
    August 5, 2011
    Date of Event
    May 31, 2011
    Report Date
    September 6, 2011
    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

    THIS DEVICE IS ONE OF THREE PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2011-00579, AND 9616099-2011-00581. THIS DEVICE (B)(4) (LOT UNKNOWN) IS DISTRIBUTED OUTSIDE THE UNITED STATES ; HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT (B)(4). THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF THREE PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2011-00579, 9616099-2011-00580, AND 9616099-2011-00581 PER THE ARTICLE PUBLISHED IN THE CIRCULATION JOURNAL OFFICIAL JOURNAL OF THE JAPANESE CIRCULATION SOCIETY "IMPACT OF HINGE MOTION ON IN-STENT RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION," YASUSHI INO, MD; TAKASHI KUBO, MD, PHD; HIRONORI KITABATA, MD, PHD; KUNIHIRO SHIMAMURA, MD; YASUTSUGU SHIONO, MD; MAKOTO ORII, MD; KEISHI OKOCHI, MD; HIROMICHI SOUGAWA, MD; TAKASHI TANIMOTO, MD, PHD; KENICHI KOMUKAI, MD; KOHEI ISHIBASHI, MD; SHIGEHO TAKARADA, MD, PHD; HIROKO NAKANISHI, MD; ATSUSHI TANAKA, MD, PHD; KEIZO KIMURA, MD, PHD; KUMIKO HIRATA, MD, PHD; MASATO MIZUKOSHI, MD, PHD; TOSHIO IMANISHI, MD, PHD; TAKASHI AKASAKA, MD, PHD. ALL PATIENTS WERE INCLUDED IN THE STUDY BETWEEN 2004 AND 2007. THIS PATIENT HAD SEVERE STENOSIS IN THE MID LAD. HINGE MOTION WITH 32 DEGREE ANGULATION WAS NOTED IN THE TARGET LESION. THREE CYPHER STENTS (2.5X18, 2.5X18 AND 3.0X28) WERE DEPLOYED IN THE PROXIMAL TO DISTAL PORTION OF THE LAD RESPECTIVELY. THE STENTS WERE OVERLAPPING. AT THE 9 MONTH FOLLOW-UP ANGIOGRAPHY, SEVERE IN-STENT RESTENOSIS WAS NOTED; ALONG WITH FRACTURE AND COMPLETE SEPARATION OF THE DISTAL STENT. BACKGROUND: A TORTUOUS LESION WITH HINGE MOTION IS REPORTEDLY A RISK FACTOR FOR IN-STENT RESTENOSIS (ISR) AFTER BARE METAL STENT IMPLANTATION. SIROLIMUS-ELUTING STENTS (SESS) IMPLANTATION HAS DRAMATICALLY REDUCED ISR. HOWEVER, SES IS A CLOSED-CELL DESIGN STENT, WHICH HAS LOW CONFORMABILITY AND FLEXIBILITY. SEVERAL STUDIES HAVE REPORTED A RELATIONSHIP BETWEEN TORTUOUS LESIONS AND STENT FRACTURE, WHICH IS ONE OF THE CAUSES OF ISR. THE EFFICACY OF SES IN A TORTUOUS LESION WITH HINGE MOTION HAS NOT BEEN FULLY EVALUATED. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE RELATIONSHIP BETWEEN TORTUOUS LESIONS AND ISR AFTER SES IMPLANTATION. METHODS AND RESULTS: THREE YEAR CLINICAL FOLLOW-UP DATA AFTER SES IMPLANTATION, INCLUDING 6-9 MONTH SCHEDULED FOLLOW-UP CORONARY ANGIOGRAPHY IN 399 CONSECUTIVE PATIENTS WITH 537 LESIONS, WERE OBTAINED. ANGLE WAS DEFINED AS THE DIFFERENCE IN THE ANGLE OF THE TARGET LESION BETWEEN THE DIASTOLE AND SYSTOLE BEFORE THE PROCEDURE. THE INCIDENCE OF ISR WAS 8.2%. THE MEAN MAXIMAL ANGLE AND ANGLE WERE LARGER IN THE ISR GROUP (47+/-22 DEGREES VS. 37+/-21 DEGREES, P=0.004 AND 20+/-13 DEGREES VS. 13+/-10 DEGREES, P<0.0001, RESPECTIVELY). INDEPENDENT PREDICTORS OF ISR WERE ANGLE, HEMODIALYSIS, AORTIC OSTIUM STENTING, AND DIABETES MELLITUS. HINGE MOTION-ASSOCIATED ISR (ANGLE 16 DEGREES) OCCURRED IN 28 LESIONS: STENT FRACTURE IN 9, STENT RECOIL IN 6, EDGE INJURY IN 10, AND OTHERS IN 3. CONCLUSIONS: THE AMOUNT OF HINGE MOTION IN TORTUOUS LESIONS SHOULD BE CONSIDERED IN THE SELECTION OF DRUG ELUTING STENT TYPES. CLINICAL IMPLICATIONS: WITH THE INCREASING USE OF DESS, PCI IS BEING APPLIED TO INCREASING NUMBERS OF COMPLEX LESIONS, INCLUDING TORTUOUS ONES WITH HINGE MOTION. WE DETERMINED THAT HINGE MOTION WAS ONE OF THE PREDICTORS OF ISR AFTER IMPLANTATION OF SESS, WHICH HAVE A CLOSED-CELL DESIGN. SECOND GENERATION DESS INCLUDING THE ZOTAROLIMUS-ELUTING STENT AND THE VEROLIMUS-ELUTING STENT HAVE AN OPEN-CELL DESIGN AND BETTER CONFORMABILITY AND FLEXIBILITY. THESE STENTS MIGHT FAVOR LOWER ISR RATES AFTER DES IMPLANTATION FOR TORTUOUS LESIONS WITH HINGE MOTION. THE ANGLE IN THE TARGET LESION CAN BE MEASURED EASILY AND QUICKLY BEFORE THE PROCEDURE, WITHOUT ANY ADDITIONAL EQUIPMENT, SUCH AS AN IVUS. THE SELECTION OF DES TYPES BASED ON THE ANGLE BEFORE THE PROCEDURE MIGHT PROVIDE A BETTER REDUCTION OF SUBSEQUENT ISR. CONCLUSION: THE ANGLE WAS ONE OF THE PREDICTORS OF ISR AFTER SES IMPLANTATION. THE AMOUNT OF HINGE MOTION IN TORTUOUS LESIONS SHOULD BE CONSIDERED IN THE SELECTION OF DES TYPES. THE PRODUCT(S) REMAINS IMPLANTED IN THE PATIENT AND IS/ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. RESTENOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. WHILE NOT OBSERVED IN THE PIVOTAL CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE LONG LESIONS WITH OVERLAPPING STENTS AND CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE VESSEL/LESION FACTORS (HINGE MOTION) THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S STENT FRACTURE AND RESTENOTIC EVENT. THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    PER THE ARTICLE "IMPACT OF HINGE MOTION ON IN-STENT RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION," ALL PATIENTS WERE INCLUDED IN THE STUDY BETWEEN 2004 AND 2007. THIS PATIENT HAD SEVERE STENOSIS IN THE MID LAD. HINGE MOTION WITH 32 DEGREE ANGULATION WAS NOTED IN THE TARGET LESION. THREE CYPHER STENTS (2.5X18, 2.5X18 AND 3.0X28) WERE DEPLOYED IN THE PROXIMAL TO DISTAL PORTION OF THE LAD RESPECTIVELY. THE STENTS WERE OVERLAPPING. AT THE (B)(6) FOLLOW-UP ANGIOGRAPHY SEVERE IN-STENT RESTENOSIS WAS NOTED; ALONG WITH FRACTURE AND COMPLETE SEPARATION OF THE DISTAL STENT.

    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 Hospitalization| R