BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2082221 · Received May 9, 2011

    Report

    Report Number
    3003742446-2011-00232
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    December 14, 2010
    Report Date
    April 12, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THYROID 0.05MG ONCE DAILY, METOPROLOL 25 MG B.I.D., BUMEX 1MG ONCE DAILY AND DEXILANT 60MG ONCE DAILY. INFORMATION RECEIVED FROM THE CYPRESS STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR HYPERTENSION, HYPERLIPIDEMIA, PREVIOUS PCI ((B)(4) 2010), RENAL INSUFFICIENCY, ANEMIA SECONDARY TO RENAL INSUFFICIENCY, HODGKIN'S DISEASE, HYPOTHYROIDISM, TONSILLECTOMY AND LEFT ARM LUMPECTOMY. THE INDICATION FOR THE INDEX PROCEDURE WAS POSITIVE FUNCTIONAL TEST FOR ISCHEMIA. THE TARGET LESION WAS THE FIRST DIAGONAL (DX1). THE LESION WAS DESCRIBED AS DE NOVO, 95% STENOSED AND SEVERELY CALCIFIED. THE LESION WAS PRE-DILATED WITH A 2.5MM X 20MM BALLOON AT 18ATMS, FOLLOWED BY THE IMPLANT OF A 2.75MM X 23MM CYPHER STENT AT 18ATMS. A 2.75MM X 13MM CYPHER STENT WAS THEN IMPLANTED AT 18 ATM, PROXIMAL AND OVERLAPPING THE FIRST STENT TO FULLY COVER THE LESION. THE STENTS WERE NOT POST-DILATED AND THE REPORTED RESIDUAL STENOSIS WAS 0%. APPROXIMATELY EIGHT MONTHS LATER THE SITE REPORTED AN ADVERSE EVENT OF TARGET LESION IN-STENT RESTENOSIS AND NON-TARGET VESSEL IN-STENT RESTENOSIS REQUIRING BALLOON ANGIOPLASTY, HOWEVER THE MEDICAL RECORDS INDICATE THAT THE LESIONS TREATED FOR RESTENOSIS WERE THE CIRCUMFLEX AND RIGHT CORONARY ARTERY. INVESTIGATION HAS BEEN PERFORMED AND CLARIFICATION OF THE EVENT HAS NOT BEEN ESTABLISHED. 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. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WITH THE INFORMATION PROVIDED IT IS NOT POSSIBLE TO ESTABLISH A RELATIONSHIP BETWEEN THE IMPLANTED STENTS AND THE REPORTED EVENT. THERE IS NO INDICATION IN THE INFORMATION PROVIDED AND THE MANUFACTURING DOCUMENTATION TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING ISSUE THEREFORE NO ACTION WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2011-00232 AND 3003742446-2011-00233.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ASPIRIN 81MG (2006 - (B)(6) 2010), LIPITOR 80MG (START: (B)(6) 2010), LISINOPRIL 40MG (START: 2006), NORVASC 10MG (START 2007), ASPIRIN 325MG (START (B)(6) 2010) AND METOPROLOL 50MG (START (B)(6) 2010). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURER REPORT NUMBERS 3003742446-2011-00232 AND 3003742446-2011-00233. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT APPROXIMATELY SEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD IN-STENT RESTENOSIS OF THE TARGET VESSEL. THE EVENT REQUIRED REVASCULARIZATION. ADDITIONALLY, THE PATIENT HAD IN-STENT RESTENOSIS OF A NON-TARGET VESSEL THAT REQUIRED REVASCULARIZATION. DURING THE INDEX PROCEDURE, A 2.75 X 23MM AND A 2.75 X 13MM WERE IMPLANTED IN THE 1ST DIAGONAL BRANCH. THE LESION HAD 95% STENOSIS AND WAS 18MM LONG. THE STENTS WERE IMPLANTED OVERLAPPING BECAUSE THE 1ST STENT DID NOT FULLY COVER THE LESION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED SEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH ACUTE CONGESTIVE HEART FAILURE. THE PATIENT WAS MARKEDLY ANEMIC WITH HEMATOCRIT OF 24. ENDOSCOPY PERFORMED DURING THIS PAST ADMISSION SHOWED HIATUS HERNIA ONLY. TWO DAYS LATER, THE PATIENT WAS TRANSFERRED FOR CARDIAC CATHETERIZATION SHOWING NORMAL LEFT VENTRICULAR FUNCTION, 90% FOCAL RESTENOSIS WITHIN THE MID RIGHT CORONARY ARTERY STENTS AND 70% TO 90% FOCAL RESTENOSIS WITHIN THE LEFT CIRCUMFLEX ARTERY STENT, AND MODEST IRREGULARITY IN THE LEFT ANTERIOR DESCENDING ARTERY. A WEEK LATER, THE PATIENT WAS ADMITTED FOR CORONARY STENTING TO A MID RESTENOTIC LEFT CIRCUMFLEX ARTERY STENT (2.5MM X 12MM LONG PROMUS DRUG-ELUTING STENT) AND MID RESTENOTIC RIGHT CORONARY ARTERY STENT (3MM X 12MM LONG PROMUS DRUG-ELUTING STENT). THE PATIENT HAS HISTORY OF DOUBLE DRUG-ELUTING STENT PLACEMENT TO THE RIGHT CORONARY ARTERY ON (B)(6) 2010 AND DOUBLE DRUG-ELUTING STENT PLACEMENT TO THE CIRCUMFLEX ARTERY ON (B)(6) 2010.

    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 15091551

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R PLAVIX 75MG ONCE DAILY| 2.5 X 20MM BALLOON