BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1741860 · Received June 30, 2010

    Report

    Report Number
    9616099-2010-00499
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 3, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: BELARDI JA, ET AL, EXAGGERATED INFLAMMATORY RESPONSE FOLLOWING SIROLIMUS-ELUTING STENT FRACTURE, INT J CARDIOL (2010), DOI:10.1016/J.IJCARD.2010.04.080ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. WHILE NOT OBSERVED IN THE (B)(4) 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. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT KNOWN WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS PATIENT'S STENT FRACTURE WITH SUBSEQUENT RESTENOSIS. ADDITIONALLY, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE CYPHER STENT IMPLANTED AND THE CORONARY MASS REPORTED. AN INVESTIGATION WAS CONDUCTED SURROUNDING THE INCREASE IN CYPHER STENT FRACTURE COMPLAINTS. AS A RESULT OF THAT INVESTIGATION LABELING CHANGES RELATED TO STENT FRACTURES WERE MADE. ADDITIONAL INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    PER ATTACHED LITERATURE ARTICLE: INFORMATION CONTAINED IN A LITERATURE REVIEW INDICATED THAT A (B)(6) MAN WITH A HISTORY OF RECURRENT RIGHT CORONARY ARTERY (RCA) IN-STENT RESTENOSIS WAS ADMITTED BECAUSE OF STABLE ANGINA. THREE MONTHS EARLIER, A 3.0 × 33-MM CYPHER STENT (CORDIS CORP., (B)(4)) WAS IMPLANTED, WITH OPTIMAL ANGIOGRAPHIC RESULTS. ON ADMISSION, A ROUNDED MYOCARDIAL MASS WAS FOUND (FIG. 1A) ENCIRCLING A FRACTURED STENT (FIG. 1B, D). CORONARY ANGIOGRAM REVEALED IN-STENT RESTENOSIS AND CONFIRMED STENT FRACTURE (FIG. 1E, F). WE PROCEEDED WITH CARDIAC SURGERY IN ORDER TO FURTHER CLARIFY THE NATURE OF THE MASS AND BY-PASS THE RCA. MICROSCOPIC SAMPLE EVALUATION OF THE EXCISED MASS DEMONSTRATED DENSE FIBROSIS COUPLED WITH MONONUCLEAR CELL INFILTRATION, WHILE THERE WERE NO NEOPLASTIC CELLS (FIG. 1C). FOLLOWING AN UNEVENTFUL SURGICAL RECOVERY, THE PATIENT WAS DISCHARGED HOME AT POSTOPERATIVE DAY 4. DRUG-ELUTING STENT FRACTURE CAN LEAD TO COMPLICATIONS SUCH AS RESTENOSIS [1], THROMBOSIS [2] AND [3], ANEURISMAL FORMATION [4] AND EVEN PERFORATION WITH CATASTROPHIC CONSEQUENCES. IN THE CURRENT CASE, THE PRESENCE OF INCREASED VESSEL RIGIDITY (I.E. LONG OVERLAPPING STENTED SEGMENTS AND THE USE OF STENT WITH CLOSED-CELL DESIGN) AND ANGULATION MAY HAVE CAUSED STENT FRACTURE [5] AND [6]. IN ADDITION, ANIMAL AND HUMAN DATA INDICATE THAT CHRONIC CORONARY VESSEL EXPOSURE TO EITHER PACLITAXEL OR SIROLIMUS-ELUTING STENT IS ASSOCIATED WITH A WHOLE HOST OF LOCAL DETRIMENTAL EFFECTS SUCH AS INFLAMMATION, ENDOTHELIAL DYSFUNCTION AND INAPPROPRIATE VESSEL REMODELING. IT IS CONCEIVABLE THAT THE DEVELOPMENT OF SEVERE DRUG-ELUTING STENT FRACTURE CREATED AN IDEAL SCENARIO FOR AN AMPLIFY VESSEL EXPOSURE TO ALL DRUG-ELUTING STENT COMPONENTS AND HENCE, PROVOKE AN EXAGGERATED INFLAMMATORY RESPONSE. TO THE BEST OF OUR KNOWLEDGE, A KELOID-LIKE FORMATION FOLLOWING DRUG-ELUTING STENT FRACTURE HAS NOT BEEN REPORTED PREVIOUSLY.

    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 46 YR Hospitalization| L| R