BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2115646 · Received June 7, 2011

    Report

    Report Number
    9616099-2011-00396
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 10, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAGNIFIED FLUOROSCOPIC VIEWS REVEALED A DISTINCT CIRCUMFERENTIAL STENT FRACTURE OF THE PROXIMAL CYPHER STENT JUST PROXIMAL TO THE OVERLAPPING CROWNS OF THE STENT STRUTS, WITH A WIDE STENT SEPARATION AT THE OUTER CURVATURE, EVEN THOUGH THERE WAS NO APPARENT MAJOR DISPLACEMENT OR MAL-ALIGNMENT OF THE 2 STENT SEGMENTS. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT PERFORMED DUE TO THE ACUTE SITUATION. IMMEDIATE THROMBECTOMY THERAPY WAS CARRIED OUT, WITH LARGE AMOUNT OF THROMBUS ASPIRATED. ANGIOGRAPHICALLY MINIMAL NEO-INTIMAL HYPERPLASIA WAS NOTED WITHIN THE STENTS. BALLOON ANGIOPLASTY WAS THEN CARRIED OUT. HOWEVER, DESPITE REPEATED ASPIRATIONS AND BALLOON DILATATIONS, AND INTRA-CORONARY ADMINISTRATION OF NITRATE AND VERAPAMIL, ONLY TIMI II FLOW COULD BE RESTORED, WITH A PERSISTENT FILLING DEFECT AMOUNTING TO 60% DIAMETER STENOSIS NOTED AT THE LESSER CURVATURE OF THE FRACTURE SITE, PRESUMABLY DUE TO PROLAPSE OF NEOINTIMAL TISSUE (OR DISSECTION FLAP) INTO THE FRACTURE GAP. THIS SITUATION MADE ADDITIONAL SCAFFOLDING BY STENTING DEEMED NECESSARY. IN VIEW OF THE ACUTE INFLAMMATORY NATURE OF THE THROMBOTIC SITE AND THE OCCURRENCE OF VERY LATE STENT THROMBOSIS IN A PREVIOUS DES SITE IN A (B)(6) SUBJECT, FURTHER DEPLOYMENT OF ANOTHER DES WAS CONSIDERED UNDESIRABLE AND POTENTIALLY DANGEROUS. A DECISION WAS MADE TO DEPLOY A 2.75X23MM EPC CAPTURE STENT (GENOUS BIO-ENGINEERED R-STENT, ORBUS NEICH MEDICAL, INC.), COVERING BOTH THE FRACTURED AND THROMBOTIC SITES, AT A MAXIMUM PRESSURE OF 10 ATMOSPHERES. A TIMI 3 FLOW WAS RESTORED IMMEDIATELY AND CHEST PAIN DISAPPEARED. GLYCOPROTEIN IIB/IIIA INHIBITOR WAS NOT GIVEN. PATIENT WAS DISCHARGED UNEVENTFULLY 3 DAYS LATER. DAPT WITH ASPIRIN AND CLOPIDOGREL WERE PRESCRIBED FOR 1 MONTH, FOLLOWED BY ASPIRIN ALONE AS PER PROTOCOL AFTER GENOUS STENT IMPLANTATION IN OUR CENTER. AT THE TIME OF THIS MANUSCRIPT PREPARATION 12 MONTHS AFTER THE PCI PROCEDURE (A PRETTY SAFE WINDOW TO EXCLUDE RECURRENCE OF STENT THROMBOSIS FOR A NON-DES), THE PATIENT REMAINED WELL WITHOUT FURTHER ISCHEMIA. 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. 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. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE OVERLAPPING STENTS, CARDIAC MOTION AND VESSEL ANGULATIONS/TORTUOSITY FOR THE NATIVE CORONARY ARTERY. THE MECHANISM OF RESTENOSIS AFTER STENT FRACTURE MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR THROMBOTIC EVENTS INCLUDE THOSE WITH LONG LESIONS, A VESSEL DIAMETER LESS THAN 3MM AND PREVIOUS THROMBUS. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING A CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE REPORTED EVENTS. HOWEVER, PROCEDURAL, PATIENT, PHARMACOLOGICAL AND/OR VESSEL/LESION CHARACTERISTICS ARE LIKELY CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    LEE ET AL IN "VERY LATE STENT THROMBOSIS DUE TO DES FRACTURE: DESCRIPTION OF A CASE AND REVIEW OF POTENTIAL CAUSES" CATHETER CARDIOVASC INTERV. 2011 APR 26. DOI: 10.1002/CCD.23101, REPORT A CASE OF NON-ST ELEVATION MYOCARDIAL INFARCTION AS A RESULT OF VERY LATE STENT THROMBOSIS (3 YEARS AFTER IMPLANTATION) DUE TO STENT FRACTURE AT THE SITE OF OVERLAP OF 2 FIRST GENERATION SIROLIMUS DES. THERE WERE INITIAL DIFFICULTIES IN RESTORING CORONARY FLOW BY CONVENTIONAL REPERFUSION THERAPIES BUT A SUCCESSFUL OUTCOME AFTER IMPLANTATION OF AN ENDOTHELIAL PROGENITOR CELL CAPTURE STENT, WITH NO FURTHER RECURRENCE OF ISCHEMIC EVENT AFTER 12 MONTHS. A (B)(6) MALE CHINESE PATIENT WAS ADMITTED BECAUSE OF SUDDEN ONSET OF SEVERE CHEST PAIN. HE HAD 3 PREVIOUS PERCUTANEOUS CORONARY INTERVENTIONS (PCI) IN 1996, 2006 AND 2007. IN (B)(6) 2006, A 3.0X23MM CYPHER DRUG-ELUTING-STENT (DES) WAS IMPLANTED TO THE MID RCA AND ANOTHER 2.5X10MM CYPHER STENT IN THE DISTAL RCA. IN (B)(6) 2007, DRIVEN BY ISCHEMIA WITH A NEW LESION DEVELOPED CLOSED TO THE DISTAL RCA STENT OUTLET, ANOTHER 2.5X18MM CYPHER STENT WAS IMPLANTED, OVERLAPPING WITH THE OUTLET OF THE PREVIOUS DISTAL RCA STENT. A COMPLETE COURSE OF 12 MONTHS DUAL ANTI-PLATELET THERAPY (DAPT) WITH ASPIRIN AND CLOPIDOGREL WAS PRESCRIBED, FOLLOWED BY ASPIRIN ALONE. HE REMAINED TOTALLY ASYMPTOMATIC AND LED A VERY ACTIVE LIFE WORKING AS A SENIOR POLICE DETECTIVE FOR 3 YEARS (2 YEARS AFTER STOPPING OF THE DAPT) UNTIL THE SUDDEN DEVELOPMENT OF ACS ON THIS ADMISSION. ON ADMISSION, THE PATIENT WAS IN MAJOR DISTRESS AND HEMODYNAMIC COLLAPSE. ECGS SHOWED NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND TROPONIN-I WAS ELEVATED. IMMEDIATE CORONARY ANGIOGRAM REVEALED MULTIPLE OCCLUSIVE THROMBI WITHIN THE DISTAL RCA DESS, PROPAGATING DOWNSTREAM WITH A THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) I FLOW ONLY.

    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 49 YR Hospitalization| L| R CRA18250