BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2073058 · Received April 29, 2011

    Report

    Report Number
    3003742446-2011-00213
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    November 8, 2010
    Report Date
    April 11, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A CORONARY ARTERY DISSECTION AFTER HAVING A CORONARY ARTERY STENT POST-DILATED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR CORONARY DISEASE, DIABETES, HYPERTENSION, SMOKING AND HYPERLIPIDEMIA. THE TARGET LESION WAS THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS DESCRIBED AS DE NOVO AND 80% STENOSED. THE LESION WAS PRE-DILATED WITH A 2.5X15MM DURASTAR BALLOON AT 10 ATMS, FOLLOWED BY THE IMPLANT OF A 3.0MM X 18MM CYPHER STENT AT 12 ATMS. THE STENT WAS POST-DILATED WITH A 3.5MM X 15MM DURASTAR BALLOON AND AN EDGE DISSECTION WAS NOTED. THE EVENT WAS TREATED WITH THE IMPLANT OF A 3.5MM X 18MM CYPHER STENT DISTAL AND OVERLAPPING THE FIRST STENT. THE STENTS WERE POST DILATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS ALSO NOTED THAT THE PATIENT ALSO HAD MODERATE DISEASE IN THE LAD, NOT HEMODYNAMICALLY SIGNIFICANT, WITH NORMAL LV FUNCTION. THE PATIENT WAS DISCHARGED THE NEXT DAY. APPROXIMATELY TWO AND A HALF MONTHS LATER, THE PATIENT EXPERIENCED CHEST PAIN, MYOCARDIAL INFARCTION WAS RULED OUT AND THE EVENT WAS REPORTED AS UNRELATED TO THE IMPLANTED STENTS AND WAS DIAGNOSED AS CHEST WALL PAIN. THE PRODUCTS WERE NOT RETURNED FOR EVALUATION AND TESTING. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE CYPHER STENT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. DISSECTIONS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THE IFU CAUTIONS THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT THE EVENT IS MOST LIKELY A RESULT OF THE INHERENT RISK OF THE PROCEDURE, THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 9616099-2011-00289 AND 3003742446-2011-00213.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2011-00289 AND 3003742446-2011-00213.

    Description of Event or Problem · 1

    DURING PLACEMENT OF THE INITIAL CYPHER STENT AND POST DILATION AN EDGE DISSECTION WAS OBSERVED AND TREATED WITH A SECOND CYPHER STENT. THE PATIENT IS A (B)(6) FEMALE WITH PREMATURE CORONARY DISEASE. THE PATIENT HAD TWO CYPHER STENTS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) IN (B)(6) 2010. THE LESION WAS DE NOVO WITH AN 80% STENOSIS. THE LESION WAS PRE-DILATED WITH A 2.5X15MM DURASTAR BALLOON AT 10 ATMS. A CYPHER ((B)(4)/ LOT 15247963) WAS IMPLANTED AT 12 ATMS AND WAS POST DILATED WITH A DURASTAR 3.5X15MM BALLOON (LOT NUMBER IS UNKNOWN). IT WAS NOTED THAT AN EDGE DISSECTION OCCURRED; THEREFORE A SECOND CYPHER ((B)(4)/ LOT 15226293) STENT WAS IMPLANTED DISTAL TO THE INITIAL STENT, OVERLAPPING, TO TREAT THE DISSECTION. THE STENTS WERE POST DILATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS ALSO NOTED THAT THE PATIENT ALSO HAD MODERATE DISEASE IN THE LAD, NOT HEMODYNAMICALLY SIGNIFICANT, WITH NORMAL LV FUNCTION. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH PRESCRIBED. APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE, THE PATIENT RETURNED WITH SEVERE CHEST PAIN THAT COULD NOT BE RELIEVED WITH NITROGLYCERIN. SHE HAD BEEN DOING WELL WITH MEDICAL TREATMENT SINCE BEING DISCHARGED, BUT WAS ADMITTED THIS TIME FOR FURTHER EVALUATION. THE PATIENT HAD MULTIPLE RISK FACTORS FOR CORONARY DISEASE INCLUDING DIABETES, HYPERTENSION, SMOKING AND HYPERLIPIDEMIA. THE EXAMS SHOWED BLOOD PRESSURE 141/74, PULSE 76. THERE WAS STERNAL TENDERNESS TO PALPITATION. CARDIAC EXAMS WERE OTHERWISE NORMAL. TROPONIN WAS NEGATIVE X2. THE PATIENT WAS DISCHARGED THE DAY AFTER ADMISSION. THE DIAGNOSIS WAS CHEST WALL PAIN, WITH NO EVIDENCE FOR MYOCARDIAL INFARCTION.

    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 15247963

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 2.5X15MM DURASTAR BALLOON