BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 4243346 · Received November 11, 2014

    Report

    Report Number
    3003742446-2014-00057
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    September 6, 2014
    Report Date
    October 23, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: WAKSMAN ET AL (2014, SEPTEMBER 6). CORRELATES AND OUTCOMES OF LATE AND VERY LATE DRUG-ELUTING STENT THROMBOSIS. JACC CARDIOVASCULAR INTERVENTIONS, 7, 1093-1102. THIS IS THE INITIAL AND FINAL REPORT FOR THIS COMPLAINT. ONE MDR REPORT IS BEING SUBMITTED FOR MULTIPLE PATIENTS WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS (QUANTITY OF 270). COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY WAKSMAN ET AL CORRELATES AND OUTCOMES OF LATE AND VERY LATE DRUG-ELUTING STENT THROMBOSIS, JACC: CARDIOVASCULAR INTERVENTIONS 7 (2014); THERE WERE 269.748 ~ 270 CASES OF STENT THROMBOSIS IN THE CYPHER GROUP OF THE STUDY. THE DESERT WAS A RETROSPECTIVELY DESIGNED, MULTICENTER, OBSERVATIONAL, CASE-CONTROL STUDY WITH AN ORIGINAL AIM TO ENROLL AS MANY AS 500 PATIENTS WITH DEFINITE LATE/VERY LATE DES THROMBOSIS AND 500 MATCHED CONTROL PATIENTS. PATIENTS WITH DEFINITE ST OF A U.S. FDA-APPROVED DES WERE INCLUDED IN THE STUDY. INCLUDED PATIENTS WERE 18 YEARS OF AGE AND OLDER AND PRESENTED WITH LATE/VERY LATE DEFINITE ST (PER THE ARC DEFINITION), CONFIRMED BY ANGIOGRAPHY OR AUTOPSY. 492 CASES OF LATE/VERY LATE DEFINITE DES THROMBOSIS FROM 21 INTERNATIONAL SITES WERE MATCHED IN A 1:1 FASHION WITH CONTROLS WITHOUT ST. CONTROLS WERE MATCHED ACCORDING TO 2 CRITERIA: SAME ENROLLING INSTITUTION AND DATE OF INITIAL DES IMPLANTATION. CONTROL PATIENTS WERE ELIGIBLE IF THEY HAD NO KNOWN HISTORY OF ST UNTIL THE TIME OF MATCHING. THERE WAS NO TREATMENT MODALITY SPECIFIED IN THIS PROTOCOL, AND THE REGISTRY DID NOT REQUIRE THE TREATING PHYSICIANS TO ALTER THERAPEUTIC STRATEGIES FOR EITHER INITIAL STENT IMPLANTATION OR ST EPISODE. A SUBSET OF CASE PATIENTS WAS FOLLOWED AFTER THE THROMBOTIC EVENT FOR AS LONG AS 12 MONTHS. DEFINITE ST HAD TO MEET THE ACADEMIC RESEARCH CONSORTIUM DEFINITION CRITERIA: ST IN THE SETTING OF AN ACUTE CORONARY SYNDROME (ACS). A TOTAL OF 984 PATIENTS (492 PAIRED CASES AND CONTROLS) WERE ENROLLED FROM 21 SITES IN THE US, CANADA, ITALY, AND SWITZERLAND. THE DES TYPE DISTRIBUTION WAS SIMILAR BETWEEN GROUPS, WITH ONE HALF OF THE LESIONS RECEIVING SES (50.2%), PACLITAXEL-ELUTING (40.3%), EVEROLIMUS-ELUTING (7%), AND ZOTAROLIMUS-ELUTING (1.8%) STENTS. THE MAJORITY OF LATE/VERY LATE ST EVENTS OCCURRED AFTER 1 YEAR (75%) AND CONTINUED TO OCCUR AS LONG AS 7.3 YEARS. THE MEDIAN TIME FROM DES IMPLANTATION TO ST WAS 764 DAYS. THE CLINICAL PRESENTATION OF LATE/VERY LATE ST WAS PREDOMINANTLY MI (66.7% STEMI AND 22.0%, NON-STEMI); AMONG THOSE PATIENTS 4.7% PRESENTED WITH CARDIOGENIC SHOCK. AT THE TIME OF ST, VISUAL THROMBUS WAS DOCUMENTED IN 98.8% AND TIMI FLOW GRADE 0 WAS OBSERVED IN 74.6% OF THE PATIENTS. OF THE LESIONS THAT UNDERWENT REPEAT PCI AT THE TIME OF ST PRESENTATION, 9.9% UNDERWENT PRE-INTERVENTION INTRAVASCULAR ULTRASOUND. THE RATES OF STENT MALAPPOSITION (PER INVESTIGATOR DETERMINATION) CONFIRMED BY ANGIOGRAPHY WAS 5.9% (26 LESIONS) AND BY INTRAVASCULAR ULTRASOUND WAS 4.7% (21 LESIONS). OF THE THROMBOTIC LESIONS THAT UNDERWENT OFFLINE QCA, THE THROMBUS CHARACTERISTICS WERE TOTAL OCCLUSION IN 3%, DIFFUSE THROMBOSIS THROUGHOUT THE STENT AND LESION IN 14.1%, FOCAL THROMBOSIS IN 9.2%, AND STENT EDGE THROMBOSIS IN 3.2% OF LESIONS. OVERALL, 30.2% OF PATIENTS WERE RECEIVING DUAL ANTIPLATELET THERAPY (DAPT) AT THE TIME OF THE LATE/VERY LATE STENT THROMBOSIS; 11% STOPPED THE DAPT WITHIN 5 DAYS BEFORE THE THROMBOSIS. THROMBOSIS ASPIRATION WAS PERFORMED IN 47% OF THE PATIENTS WHO PRESENTED WITH LATE ST AND BALLOON ANGIOPLASTY IN 78.1%; DES REIMPLANTATION WAS PERFORMED IN 30.8% OF THE LESIONS AND BMS IN 20.6% OF THE LESIONS. ADMISSION TO THE INTENSIVE CARE UNIT WAS REQUIRED IN 72.4% OF THE PATIENTS. THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY REMAIN IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THESE EVENTS HAS BEEN PROVIDED. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. DISCONTINUATION OF ANTIPLATELET THERAPY MAY CAUSE THROMBUS FORMATION. 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. THE IFU NOTES THAT PATIENTS WHO HAVE UNDERGONE CORONARY STENTING, THE PERSISTENCE OF A THROMBUS SHOULD BE CONSIDERED A MARKER FOR SUBSEQUENT THROMBOTIC OCCLUSIONS. THESE PATIENTS SHOULD BE MONITORED VERY CAREFULLY DURING THE FIRST MONTH AFTER STENT IMPLANTATION. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, NO DETERMINATION REGARDING POTENTIAL CONTRIBUTING FACTORS TO THIS EVENT COULD BE MADE. THERE IS NO INDICATION THAT THE EVENTS REPORTED IN THE ARTICLE ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY WAKSMAN ET AL CORRELATES AND OUTCOMES OF LATE AND VERY LATE DRUG-ELUTING STENT THROMBOSIS, JACC: CARDIOVASCULAR INTERVENTIONS 7 (2014); THERE WERE 269.748 ~ 270 CASES OF STENT THROMBOSIS IN THE CYPHER GROUP OF THE STUDY. THE DESERT WAS A RETROSPECTIVELY DESIGNED, MULTICENTER, OBSERVATIONAL, CASE-CONTROL STUDY WITH AN ORIGINAL AIM TO ENROLL AS MANY AS 500 PATIENTS WITH DEFINITE LATE/VERY LATE DES THROMBOSIS AND 500 MATCHED CONTROL PATIENTS. PATIENTS WITH DEFINITE ST OF A U.S. FDA-APPROVED DES WERE INCLUDED IN THE STUDY. INCLUDED PATIENTS WERE 18 YEARS OF AGE AND OLDER AND PRESENTED WITH LATE/VERY LATE DEFINITE ST (PER THE ARC DEFINITION), CONFIRMED BY ANGIOGRAPHY OR AUTOPSY. 492 CASES OF LATE/VERY LATE DEFINITE DES THROMBOSIS FROM 21 INTERNATIONAL SITES WERE MATCHED IN A 1:1 FASHION WITH CONTROLS WITHOUT ST. CONTROLS WERE MATCHED ACCORDING TO 2 CRITERIA: SAME ENROLLING INSTITUTION AND DATE OF INITIAL DES IMPLANTATION. CONTROL PATIENTS WERE ELIGIBLE IF THEY HAD NO KNOWN HISTORY OF ST UNTIL THE TIME OF MATCHING. THERE WAS NO TREATMENT MODALITY SPECIFIED IN THIS PROTOCOL, AND THE REGISTRY DID NOT REQUIRE THE TREATING PHYSICIANS TO ALTER THERAPEUTIC STRATEGIES FOR EITHER INITIAL STENT IMPLANTATION OR ST EPISODE. A SUBSET OF CASE PATIENTS WAS FOLLOWED AFTER THE THROMBOTIC EVENT FOR AS LONG AS 12 MONTHS. DEFINITE ST HAD TO MEET THE ACADEMIC RESEARCH CONSORTIUM DEFINITION CRITERIA: ST IN THE SETTING OF AN ACUTE CORONARY SYNDROME (ACS). A TOTAL OF 984 PATIENTS (492 PAIRED CASES AND CONTROLS) WERE ENROLLED FROM 21 SITES IN THE US, CANADA, ITALY, AND SWITZERLAND. THE DES TYPE DISTRIBUTION WAS SIMILAR BETWEEN GROUPS, WITH ONE HALF OF THE LESIONS RECEIVING SES (50.2%), PACLITAXEL-ELUTING (40.3%), EVEROLIMUS-ELUTING (7%), AND ZOTAROLIMUS-ELUTING (1.8%) STENTS. THE MAJORITY OF LATE/VERY LATE ST EVENTS OCCURRED AFTER 1 YEAR (75%) AND CONTINUED TO OCCUR AS LONG AS 7.3 YEARS. THE MEDIAN TIME FROM DES IMPLANTATION TO ST WAS 764 DAYS. THE CLINICAL PRESENTATION OF LATE/VERY LATE ST WAS PREDOMINANTLY MI (66.7% STEMI AND 22.0%, NON-STEMI); AMONG THOSE PATIENTS 4.7% PRESENTED WITH CARDIOGENIC SHOCK. AT THE TIME OF ST, VISUAL THROMBUS WAS DOCUMENTED IN 98.8% AND TIMI FLOW GRADE 0 WAS OBSERVED IN 74.6% OF THE PATIENTS. OF THE LESIONS THAT UNDERWENT REPEAT PCI AT THE TIME OF ST PRESENTATION, 9.9% UNDERWENT PRE-INTERVENTION INTRAVASCULAR ULTRASOUND. THE RATES OF STENT MALAPPOSITION (PER INVESTIGATOR DETERMINATION) CONFIRMED BY ANGIOGRAPHY WAS 5.9% (26 LESIONS) AND BY INTRAVASCULAR ULTRASOUND WAS 4.7% (21 LESIONS). OF THE THROMBOTIC LESIONS THAT UNDERWENT OFFLINE QCA, THE THROMBUS CHARACTERISTICS WERE TOTAL OCCLUSION IN 3%, DIFFUSE THROMBOSIS THROUGHOUT THE STENT AND LESION IN 14.1%, FOCAL THROMBOSIS IN 9.2%, AND STENT EDGE THROMBOSIS IN 3.2% OF LESIONS. OVERALL, 30.2% OF PATIENTS WERE RECEIVING DUAL ANTIPLATELET THERAPY (DAPT) AT THE TIME OF THE LATE/VERY LATE STENT THROMBOSIS; 11% STOPPED THE DAPT WITHIN 5 DAYS BEFORE THE THROMBOSIS. THROMBOSIS ASPIRATION WAS PERFORMED IN 47% OF THE PATIENTS WHO PRESENTED WITH LATE ST AND BALLOON ANGIOPLASTY IN 78.1%; DES REIMPLANTATION WAS PERFORMED IN 30.8% OF THE LESIONS AND BMS IN 20.6% OF THE LESIONS. ADMISSION TO THE INTENSIVE CARE UNIT WAS REQUIRED IN 72.4% OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725528 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S