BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2852289 · Received November 30, 2012

    Report

    Report Number
    3003742446-2012-00535
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    March 19, 2012
    Report Date
    November 6, 2012
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REGARDING (B)(6) 2012 PROCEDURE THROUGH CEC ADJUDICATION MINUTES. REPEAT ANGIOGRAPHY REVEALED 53% MARGINAL ISR IN THE MRCA AS NOTED BY THE ANGIOGRAPHIC CORE LAB. TARGET LESION REVASCULARIZATION WAS CONDUCTED. THE CATH NOTES NOTED PATENT STENTS IN THE RAMUS, 1OM, AND MRCA, WITH A NEW FOCAL 80% LESION JUST DISTAL TO THE RCA STENT. A BALLOON ANGIOPLASTY + STENTING WERE CONDUCTED. CONCOMITANT MEDICATIONS INCLUDED BIVALIRUDIN, CLONIDINE, PLAVIX, DARVOCET-N, FISH OIL, LOTENSIN, NITROSTAT, PEPCID, PRAVASTATIN, AND XANAX. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(4) STUDY, A PATIENT EXPERIENCED CORONARY RESTENOSIS POST INDEX PROCEDURE. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING ANGINA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, CURRENT SMOKER, COMPAZINE AND AN IODINE ALLERGY. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED THREE VESSELS DISEASED. THE INDICATION FOR THE PROCEDURE WAS AN ANGINA PECTORIS. THE PROXIMAL EDGE OF THE RAMUS WAS DESCRIBED AS 10MM IN LENGTH, ECCENTRIC, CLASS A, AND DE NOVO WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. THE LESION WAS TREATED WITH A 2.5 X 18MM CYPHER RX AT 12ATM BY DIRECT STENTING. THE STENT WAS POST-DILATED WITH A 3.0 X 12MM BALLOON AT 16ATM TO FULLY EXPAND THE STENT. THE PROXIMAL EDGE OF THE 1ST OBTUSE MARGINAL WAS DESCRIBED AS 8MM IN LENGTH, ECCENTRIC, CLASS A, AND DE NOVO WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE LESION WAS TREATED WITH A 3.0 X 13MM CYPHER RX AT 14ATM BY DIRECT STENTING WITHOUT POST-DILATION. THE MID RIGHT CORONARY ARTERY WAS DESCRIBED AS 14MM IN LENGTH, ECCENTRIC, CLASS A, DE NOVO WITH 80% STENOSIS. THE LESION WAS TREATED WITH A 3.0 X 18MM CYPHER RX AT 16ATM BY DIRECT STENTING WITHOUT POST-DILATION. THERE WERE NO PROCEDURAL AND ANGIOGRAPHIC COMPLICATIONS AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY TWENTY-FIVE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED CARDIAC CHEST PAIN AND UNDERWENT REVASCULARIZATION OF THE MID RIGHT CORONARY ARTERY (TARGET VESSEL, NON-TARGET LESION). THE EVENT WAS RESOLVED WITHOUT SEQUELAE AFTER SUCCESSFUL REVASCULARIZATION. IT WAS REPORTED THAT THE STENTS IMPLANTED IN THE 1ST OM, RAMUS, AND MID RCA DURING INDEX PROCEDURE WERE NOTED TO BE PATENT AT THE TIME OF REVASCULARIZATION. ACCORDING TO THE INVESTIGATOR, A CARDIAC CHEST PAIN WAS NOT RELATED TO THE CYPHER STENT, INDEX PROCEDURE OR STUDY DRUG. ADDITIONAL INFORMATION RECEIVED REGARDING (B)(6) 2012 PROCEDURE THROUGH CEC ADJUDICATION MINUTES. REPEAT ANGIOGRAPHY REVEALED 53% MARGINAL ISR IN THE MRCA AS NOTED BY THE ANGIOGRAPHIC CORE LAB. TARGET LESION REVASCULARIZATION WAS CONDUCTED. THE CATH NOTES NOTED PATENT STENTS IN THE RAMUS, 1OM, AND MRCA, WITH A NEW FOCAL 80% LESION JUST DISTAL TO THE RCA STENT. A BALLOON ANGIOPLASTY + STENTING WERE CONDUCTED. THE CYPHER 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 15109288 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. 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. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND SMOKING.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6) STUDY, A PATIENT EXPERIENCED CARDIAC CHEST PAIN APPROXIMATELY TWENTY-FIVE MONTHS AFTER THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED THREE VESSELS DISEASED. THE INDICATION FOR THE PROCEDURE WAS AN ANGINA PECTORIS. THE PROXIMAL EDGE OF THE RAMUS WAS DESCRIBED AS 10MM IN LENGTH, ECCENTRIC, CLASS A, AND DE NOVO WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. THE LESION WAS TREATED WITH A 2.5 X 18MM CYPHER RX AT 12ATM BY DIRECT STENTING. THE STENT WAS POST-DILATED WITH A 3.0 X 12MM BALLOON AT 16ATM TO FULLY EXPAND THE STENT. THE PROXIMAL EDGE OF THE 1ST OBTUSE MARGINAL WAS DESCRIBED AS 8MM IN LENGTH, ECCENTRIC, CLASS A, AND DE NOVO WITH 90% STENOSIS. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE LESION WAS TREATED WITH A 3.0 X 13MM CYPHER RX AT 14ATM BY DIRECT STENTING WITHOUT POST-DILATION. THE MID RIGHT CORONARY ARTERY WAS DESCRIBED AS 14MM IN LENGTH, ECCENTRIC, CLASS A, DE NOVO WITH 80% STENOSIS. THE LESION WAS TREATED WITH A 3.0 X 18MM CYPHER RX AT 16ATM BY DIRECT STENTING WITHOUT POST-DILATION. THERE WERE NO PROCEDURAL AND ANGIOGRAPHIC COMPLICATIONS AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY TWENTY-FIVE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED CARDIAC CHEST PAIN AND UNDERWENT REVASCULARIZATION OF THE MID RIGHT CORONARY ARTERY (TARGET VESSEL, NON-TARGET LESION). THE EVENT WAS RESOLVED WITHOUT SEQUELAE AFTER SUCCESSFUL REVASCULARIZATION. IT WAS REPORTED THAT THE NEW LESION WAS NOT WITHIN 5MM OF THE MID RCA STENT IMPLANTED DURING INDEX PROCEDURE BASED ON THE PI. THE LENGTH OF THE LESION NOTED WAS 12MM AT THE TIME OF THE REVASCULARIZATION. IT WAS REPORTED THAT THE STENTS IMPLANTED IN THE 1ST OM, RAMUS, AND MID RCA DURING INDEX PROCEDURE WERE NOTED TO BE PATENT AT THE TIME OF REVASCULARIZATION. ACCORDING TO THE INVESTIGATOR, A CARDIAC CHEST PAIN WAS NOT RELATED TO THE CYPHER STENT, INDEX PROCEDURE OR STUDY DRUG.

    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 15109288

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R