BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPAMYCIN CLINICAL 3.0 X 18 MM

    MDR report key: 1051661 · Received May 21, 2008

    Report

    Report Number
    9610978-2008-00131
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 25, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9610978-2008-00130. THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. HOWEVER, A REVIEW OF MANUFACTURING ROUTE SHEETS WAS COMPLETED AND THE RESULTS INDICATED THESE PRODUCTS MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. PULMONARY EDEMA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY DISEASE. THERE ARE MANY FACTORS THAT CAN CAUSE PULMONARY EDEMA SUCH AS HEART ARRHYTHMIAS THAT AFFECT THE PUMPING ACTION OF THE HEART AND RENDER IT INEFFECTIVE. THE INABILITY FOR THE HEART TO EFFECTIVELY PUMP BLOOD THROUGH THE SYSTEMIC CIRCULATION CAN LEAD TO FLUID CONGESTION AROUND THE LUNGS LEADING TO PULMONARY EDEMA. ATRIAL FIBRILLATION IS AN ARRHYTHMIA THAT CAN HAVE THIS EFFECT ON THE HEARTS PUMPING CAPABILITIES. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT THE PATIENTS UNDERLYING MEDICAL HISTORY OF ATRIAL FIBRILLATION MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NOTHING TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING OF THE IMPLANTED DEVICE.

    Description of Event or Problem · 1

    FOUR AND A HALF MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR A WEEK FOR A NECROTIC SKIN LESION AND SEVERE PAIN TO INFERIOR RIGHT LIMB. THE FINAL DIAGNOSIS WAS REFLEX SYMPATHETIC DYSTROPHY RELATED TO FOOT TRAUMA WHICH OCCURRED 3 MONTHS AGO. THE NECROTIC SKIN LESION WAS SECONDARY TO THE WARFARIN, NOT RULED OUT BUT VERY ATYPICAL. THE PT WAS DISCHARGED IN STABLE, IMPROVED CONDITION. RELATIONSHIP TO THE STUDY IS NOTED AS UNLIKELY. ADDENDUM EVENT DATE 2008: THE PT WAS HOSPITALIZED FOR 4 DAYS WITH ACUTE PULMONARY EDEMA AND RECEIVED MEDICAL TREATMENT. THE EVENT WAS RELATED TO AN EVENT OF ACUTE ATRIAL FIBRILLATION. THE REPORTER NOTED THE EVENT AS NOT RELATED TO THE DEVICE OR THE PROCEDURE AND THE EVENT RESOLVED. THE PT WAS A MALE WITH A HISTORY OF SMOKING, PERIPHERAL VASCULAR DISEASE, AND PREMATURE CORONARY ARTERY DISEASE IN A FIRST DEGREE RELATIVE. THE PT EXPERIENCED A NON Q-WAVE MI 4 DAYS BEFORE HOSPITALIZATION. INDICATION FOR THE INDEX PROCEDURE WAS POST MI ANGINA. THE PATIENT HAD 2 VESSELS WITH >50% STENOSIS, THE MID RIGHT CORONARY ARTERY (RCA) AND THE 1ST DIAGONAL. THE TARGET VESSEL WAS THE MID RCA. THE VESSEL DIAMETER WAS 2.75MM AND THE LESION LENGTH WAS 24MM. PRE-PROCEDURE STENOSIS WAS 90% AND TIMI FLOW WAS 1. THERE WAS NO CALCIFICATION AND NO TORTUOSITY. THE VESSEL WAS PRE-DILATED WITH A 2.5 MM BALLOON AT 10 ATM. TWO STUDY STENTS WERE DELIVERED TO THE TARGET LESION. THE FIRST STENT (3.0 X 18MM) WAS DEPLOYED AT 12 ATM. THE 2ND STENT (3.0 X 8MM) WAS PLACED PROXIMAL TO THE FIRST AND DEPLOYED AT 16 ATM. THE STENTS WERE OVERLAPPING. THE STENTS WERE POST-DILATED WITH THE DELIVERY BALLOON AT 16 ATM. AGGRASTAT AND HEPARIN WERE USED DURING THE PROCEDURE. CARDIAC ENZYMES WERE ELEVATED PRIOR TO THE PROCEDURE BUT NORMAL POST-PROCEDURE. THE HIGHEST ACT WAS 344. FINAL STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE PATIENT WAS DISCHARGED 3 DAYS LATER. AT DISCHARGE, THE PT HAD ARRHYTHMIA (1ST AV BLOCK AND INTERMITTENT ATRIAL-FLUTTER FIBRILLATION) AND A FEVER OF UNKNOWN ETIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPAMYCIN CLINICAL 3.0 X 18 MM DRUG-ELUTING STENT NIQ CORDIS EUROPA, N.V. NA S0601971

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R VERAPAMIL| TIROFIBAN| RAMIPRIL| GUIDEWIRE: CORDIS DT SUPERSOFT 0.014| PLAVIX| METOPROLOL| LORAZEPAM| FUROSEMIDE| EMPRACET| DIPHENHYDRAMINE| CIPROFLOXACIN| AGGRASTAT| DEVICES: GUIDING CATHETERS:| XYLOCAINE| CEFTAZIDIME| ASPIRIN| PRAVASTATIN| POTASSIUM| BOSTON SCIENTIFIC KIMNY 6F| NITROGLYCERIN| WARFARIN| MEDTRONIC !S JR 4 6F| HEPARIN