BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2615705 · Received June 14, 2012

    Report

    Report Number
    3003742446-2012-00376
    Event Type
    Injury
    Date Received
    June 14, 2012
    Date of Event
    November 3, 2009
    Report Date
    May 22, 2012
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT SUFFERED A PERI-PROCEDURAL MI DURING THE INDEX PROCEDURE. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY DYSLIPIDEMIA, HYPERTENSION, CHF AND CURRENT SMOKER. THE INDICATION FOR THE INDEX PROCEDURE WAS ANGINA AND A POSITIVE FUNCTIONAL STUDY. ANGIOGRAPHY REVEALED A 70% STENOSIS IN THE MID LAD. IN (B)(6) 2009, THE INDEX PROCEDURE WAS PERFORMED FOR TREATMENT OF ONE TARGET LESION. A SINGLE STENT IMPLANTATION WAS SUCCESSFULLY COMPLETED. THE CORE LAB REPORTED A IN THE PROXIMAL LAD WITH A 19% RESIDUAL STENOSIS, NO DISSECTION AND TIMI 3 FLOW AND A 60% SIDE BRANCH STENOSIS OF THE 1ST SEPTAL. PRE-PROCEDURE THE CK WAS 43, THE CKMB WAS 1.0 AND THE TROPONIN WAS 0.01. POST-PROCEDURE THE CK WAS 57, THE CKMB WAS 5.4 AND THE TROPONIN WAS 0.38. IN THE NEXT SET, THE CK WAS 41, THE CKMB WAS 7.4 AND THE TROPONIN WAS 0.72. IN THE NEXT SET, THE CK WAS 62, THE CKMB WAS 6.2 AND THE TROPONIN WAS 0.54. IN THE NEXT SET, THE CK WAS 56, THE CKMB WAS 5.3 AND THE TROPONIN WAS 0.56. IN THE NEXT SET, THE CK WAS 44, THE CKMB WAS 3.0 AND THE TROPONIN WAS 0.30. THE ECG CORE LAB REPORTED PERSISTENT ACUTE/RECENT ANTERIOR ST DEPRESSION AND NO NEW Q WAVES. THE CEC COMMITTEE HAS DEEMED THIS ENZYME ELEVATION AS AN ARC PERI-PROCEDURAL PCI THUS THE FILE HAS BEEN CODED FOR MI. THE SITE REPORTED NO POST PROCEDURE COMPLICATIONS; HOWEVER, THE DISCHARGE SUMMARY NOTED THAT THE PATIENT HAD A RIGHT GROIN HEMATOMA. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE, DELAYED SECONDARY TO THE ENZYME ELEVATION, ON DUAL ANTI-PLATELET THERAPY. THE STUDY STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15014914 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    ANOTHER SET REVEALED THAT THE CK WAS 56, THE CKMB WAS 5.3 AND THE TROPONIN I WAS 0.56. APPROXIMATELY 24 HOURS AFTER THE INDEX, THE CK WAS 44, THE CKMB WAS 3.0 AND THE TROPONIN I WAS 0.30. AS PER THE ADJUDICATION REPORT, THE ECG CORE LAB REPORTED PERSISTENT ACUTE/RECENT ANTERIOR ST DEPRESSION AND NO NEW Q WAVES, BUT THE ELEVATION WAS LATER DIAGNOSED AS A PERIPROCEDURAL MI BASED ON THE RECEIVED ADJUDICATION MINUTES. CONCOMITANT MEDICATIONS INCLUDED ACE INHIBITORS, ARMOUR THYROID, ASPIRIN, BETA BLOCKING AGENTS, PLAVIX, HEPARIN, HMG COA REDUCTASE INHIBITORS, LISINOPRIL, LOPRESSOR, NEXIUM, PRAVASTATIN, PREMARIN, TOPAMAX, WELLBUTRIN, ZOCOR, AND ZOLOFT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE CEC ADJUDICATION MINUTES OF THE (B)(4) STUDY INDICATED THAT THE PATIENT EXPERIENCED PERIPROCEDURAL MYOCARDIAL INFARCTION POST INDEX PROCEDURE AND WAS KEPT ONE EXTRA DAY DUE TO CARDIAC ENZYME ELEVATION. PCI WAS PERFORMED ON A 70% DE NOVO LESION IN THE MID LAD OF 13MM IN LENGTH IN A 3.0MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS B1. A 3.0X13MM CYPHER RX STENT WAS DEPLOYED AT 11ATM BY DIRECT STENTING. POST-DILATION WAS PERFORMED WITH A 3.5X8MM BALLOON AT 17ATM AS A STANDARD PRACTICE. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI 3 FLOW WAS RESTORED POST-PROCEDURE. PRE-PROCEDURE, THE CK WAS 43 (NL 234), THE CKMB WAS 1.2 (NL 6.0) AND THE TROPONIN I WAS 0.03 (NL 0.04). ANOTHER SET OF TESTING REVEALED THAT THE CK WAS 34, THE CKMB WAS 1.0 AND THE TROPONIN-I WAS 0.01. POST-PROCEDURE, THE CK WAS 57, THE CKMB WAS 5.4 AND THE TROPONIN I WAS 0.38. 16-24 HOURS POST INDEX PROCEDURE, THE CK WAS 41, THE CKMB WAS 7.4 AND THE TROPONIN I WAS 0.72. ANOTHER SET OF TESTING REVEALED THAT THE CK WAS 62, THE CKMB WAS 6.2 AND THE TROPONIN I WAS 0.54. ANOTHER SET REVEALED THAT THE CK WAS 56, THE CKMB WAS 5.3 AND THE TROPONIN I WAS 0.56. APPROXIMATELY 24 HOURS AFTER THE INDEX, THE CK WAS 44, THE CKMB WAS 3.0 AND THE TROPONIN I WAS 0.30. AS PER THE ADJUDICATION REPORT, THE ECG CORE LAB REPORTED PERSISTENT ACUTE/RECENT ANTERIOR ST DEPRESSION AND NO NEW Q WAVES, BUT THE ELEVATION WAS LATER DIAGNOSED AS A PERIPROCEDURAL MI BASED ON THE RECEIVED ADJUDICATION MINUTES. THE DISCHARGE SUMMARY ALSO NOTED THAT THE PATIENT WAS KEPT ONE EXTRA DAY FOR OBSERVATION DUE TO AN ELEVATION IN CKMB AND TROPONIN POST-PROCEDURE. OVER THE 24 HOURS, THE PATIENT'S CARDIAC ENZYMES TRENDED DOWNWARD. THE PATIENT WAS DISCHARGED ON TWO DAYS LATER ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15014914

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening