BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2121160 · Received June 13, 2011

    Report

    Report Number
    3003742446-2011-00301
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 31, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT POST INDEX PROCEDURE, THIS (B)(4) STUDY PATIENT HAD ELEVATED CARDIAC ENZYMES AND APPROXIMATELY SIX MONTHS POST INDEX HAD IN-STENT RESTENOSIS. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING ANGINA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, ANGINA PECTORIS, PERIPHERAL ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, ATRIAL FIBRILLATION, DIABETES MELLITUS (DIABETES MELLITUS WITH RETINOPATHY, NEUROPATHY, OR NEPHROPATHY AND TYPE II), CURRENT SMOKER, ALLERGY (SULFA, PENICILLIN, RESTASIS, ACE INHIBITOR AND ERYTHROMYCIN ALLERGY), HYPOTHYROID, STATUS POST THYROIDECTOMY, SJOGRENS SYNDROME, CHRONIC OSTEOMYELITIS RIGHT ANKLE FOOT AND STATUS POST RENAL TRANSPLANT. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA. A LEFT HEART CATHETERIZATION REVEALED MODERATE LEFT CIRCUMFLEX (LCX) DISEASE AND AN 80% STENOSIS OF THE MID LEFT ANTERIOR DESCENDING (LAD). THE INDEX PROCEDURE WAS PERFORMED TO THE MID LAD WITH A 2.5 X 18MM CYPHER DES (CXS18225/ LOT 15247942). THE STENT WAS NOT POST DILATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. POST INDEX PROCEDURE, THE PATIENT'S TROPONIN WAS ELEVATED. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH AN ASPIRIN AND CLOPIDOGREL REGIMEN PRESCRIBED. APPROXIMATELY SIX MONTHS POST INDEX PROCEDURE, THE PATIENT HAD COMPLAINTS OF CHEST PAIN WITH A RECENT ADMISSION FOR UNSTABLE ANGINA. A DIAGNOSTIC CATHETERIZATION WAS PERFORMED TO RULE OUT ONGOING ISCHEMIA. THE ANGIOGRAM REVEALED A TUBULAR, ECCENTRIC, MILDLY CALCIFIED, 90% IN-STENT RESTENOSIS IN THE PREVIOUSLY DEPLOYED STENT TO THE MID-LAD WITH DISTAL TIMI3 FLOW. CORONARY INTERVENTION WAS PERFORMED WITH PRE-DILATION OF THE LESION WITH 1.5 X 8MM APEX BALLOON AND PLACEMENT OF A 2.5 X 8MM ENDEAVOR DES. POST-INTERVENTION THERE IS NO RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. THE INDEX STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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. ELEVATED CARDIAC ENZYMES ARE A 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. 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. 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 IN-STENT 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. 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 DIABETES.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, APPROXIMATELY SIX MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED IN-STENT RESTENOSIS. THE PATIENT IS A (B)(6) FEMALE PATIENT WHO WAS ENROLLED IN THE (B)(4) STUDY. MEDICAL HISTORY INCLUDES CORONARY ARTERY DISEASE (CAD), RENAL TRANSPLANTATION IN 2009, PAROXYSMAL ATRIAL FIB, THROMBOCYTOPENIA, HYPERTENSION, AND TYPE II DIABETES. THE REASON FOR INTERVENTION WAS UNSTABLE ANGINA. A LEFT HEART CATHETERIZATION REVEALED MODERATE LEFT CIRCUMFLEX (LCX) DISEASE AND AN 80% STENOSIS OF THE MID LEFT ANTERIOR DESCENDING (LAD). INTERVENTION WAS PERFORMED TO THE MID LAD WITH A 2.5 X 18MM CYPHER DES (CXS18225/ LOT 15247942). THE STENT WAS NOT POST DILATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. POST INDEX PROCEDURE, THE PATIENT TROPONIN WAS ELEVATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE, THE PATIENT HAD COMPLAINTS OF CHEST PAIN WITH A RECENT ADMISSION FOR UNSTABLE ANGINA. A DIAGNOSTIC CATHETERIZATION WAS PERFORMED TO RULE OUT ONGOING ISCHEMIA. THE ANGIOGRAM REVEALED A TUBULAR, ECCENTRIC, MILDLY CALCIFIED, 90% IN-STENT RESTENOSIS IN THE PREVIOUSLY DEPLOYED STENT TO THE MID-LAD WITH DISTAL TIMI 3 FLOW. CORONARY INTERVENTION WAS PERFORMED WITH PRE-DILATION OF THE LESION WITH 1.5 X 8MM APEX BALLOON AND PLACEMENT OF A 2.5 X 8MM ENDEAVOR DES. POST-INTERVENTION THERE IS NO RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PATIENT TOLERATED THE PATIENT WELL WITH NO COMPLICATIONS.

    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 15247942

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R