BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPAMYCIN CLINICAL 2.5 X 18 MM

    MDR report key: 843940 · Received April 26, 2007

    Report

    Report Number
    9610978-2007-00233
    Event Type
    Injury
    Date Received
    April 26, 2007
    Date of Event
    March 29, 2006
    Report Date
    February 26, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: THESE RAPAMYCIN STENTS ARE DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, THEY ARE SIMILAR TO THE UNITED STATES CYPER SIROLIMUS-ELUTING CORONARY STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 961097-2007-00233 AND 9610978-2007-00234. THIS EVENT WAS BROUGHT TO OUR ATTENTION BY THE STUDY. THE EVENT INVOLVED A MALE WITH A MEDICAL HISTORY OF PREVIOUS Q-WAVE MI AND A FAMILY HISTORY OF CORONARY ARTERY DISEASE AND SMOKING. THIS PATIENTS' HISTORY PLACES HIM AT INCREASED RISK OF MACE. THE REASON FOR INITIAL ADMISSION TO HOSPITAL IS UNK; HOWEVER, A CORONARY ANGIOGRAM REVEALED A NON-CALCIFIED AND NON-TOTUOUS 22MM LESION IN THE DISTAL CIRCUMFLEX. THE REFERENCE VESSEL DIAMETER WAS 3.0MM AND THE DEGREE OF STENOSIS WAS 90%. THE LESION WAS TREATED WITH PRE-DILATION FOLLOWED BY IMPLANTATION OF A 2.50 X 18MM CYPHER STENT AT 12 ATM. AND A 3.00 X 8MM CYPHER STENT AT 10 ATM. OVERLAPPING AND PROXIMAL TO THE FIRST. POST-DILATION WAS PERFORMED RESULTING IN A RESIDUAL STENOSIS OF 0% AND FINAL TIMI FLOW OF 3. NO OTHER INFORMATION WAS GIVEN REGARDING THE INDEX PROCEDURE. APPROXIMATELY FOUR YEARS AND TWO MONTHS POST INDEX PROCEDURE THE PATIENT WAS ADMITTED TO HOSPITAL WITH DIAPHORESIS AND THORACIC PAIN RADIATING TO THE LEFT ELBOW. THE PAIN RESOLVED WITH SUBLINGUAL NITRATES. THE FOLLOWING DAY THE PATIENT VISTED THE OUTPATIENT CLINIC AND WAS REFERRED TO HOSPITAL BASED ON ELECTROCARDIOGRAM RESULTS. IT WAS REPORTED HE WAS DIAGNOSED WITH ACUTE MYOCARDIAL INFARCTION BASED ON ST CHANGES IN THE ECG AND POSITIVE CARDIAC ENZYMES. THE PATIENT WAS STARTED ON CLOPIDOGREL, ENOXAPRIN AND ASA. A CORONARY ANGIOGRAM TWO DAYS LATER REVEALED A 75% ECCENTRIC LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND A 90% TUBULAR LESION IN THE MID LAD. THE CIRCUMFLEX HAD A 90% STENOTIC LESION DISTAL TO THE STENTS PLACED DURING THE INDEX PROCEDURE. THE PROXIMAL RIGHT CORONARY WAS LESS THAN 25% CALCIFIED. THE MID RIGHT CORONARY HAD A 75% LESION HAD A 90% STENOSIS WAS FOUND IN THE POSTERIOR DESCENDING BRANCH. TREATMENT INCLUDED IMPLANTATION OF A 2.50 X 12MM TAXUS STENT IN THE DISTAL CIRCUMFLEX AND THE PROXIMAL LAD. A 3.50 X 23MM CYPHER STENT WAS PLACED IN THE RIGHT CORONARY ARTERY. THE STENTS REMAIN IMPLANTED IN THE PATIENT AND THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT THE CLINICAL RELATIONSHIP BETWEEN THE DEVICE(S) AND THE EVENT; HOWEVER; THERE ARE PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO IT. THERE IS NOT CLEAR INDICATION THAT THIS EVENT WAS DESIGN OR MANUFACTURING RELATED.

    Description of Event or Problem · 1

    APPROXIMATELY FOUR YEARS AND TWO MONTHS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR OPPRESSIVE THORACIC PAIN AND SWEATING, RADIATING TO THE LEFT ELBOW. THE PAIN STOPPED WHILE TAKING SUB LINGUAL CANFINITRINE. THE NEXT DAY THE PATIENT VISITED THE OUTPATIENT CLINIC AND AN ELECTRO CARDIOGRAM (ECG) WAS TAKEN. THE PATIENT WAS REFERRED TO THE EMERGENCY ROOM AND AN ECG WAS PERFORMED THERE AS WELL. THE PATIENT EXPERIENCED AN ACUTE MYOCARDIAL INFARCTION THE NEXT DAY. THERE WAS ISCHEMIC PAIN FOR MORE THAN 20 MINUTES THAT COULD NOT BE RELIEVED BY NTG. NEW ST SEGMENT DEPRESSIONS OF 1MM IN V4-V6 WITH T WAVE INVERSION COULD BE DETECTED. THERE WAS POSITIVE CARDIAC ENZYME DAMAGE (CK545, MB 46.9, TRL3.68) AND THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS STARTED ON CLOPIDROGEL TREATMENT, ANTICOAGULANT WITH ENOXAPARINE, NTG, GASTRIC PROTECTORS AND STAY ESTATINED, BETA-BLOCKERS AND AAS. THE PATIENT REMAINED ASYMPTOMATIC SINCE HE WAS ADMITTED WITH STABLE HEMODYNAMICALLY TAS WITHIN RANGE 110-65 AND CCF 65-60. ENZYMATIC EVOLUTION SHOWS AN INCREASE OF TROPONIN I UP TO 4.11 AND STARTED PROGRESSIVELY DECREASE. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE TWO DAYS LATER. A CORONARY ANGIOGRAM AND RE-PTCA WAS PERFORMED. THE ANGIOGRAM REVEALED APICAL HYPOKINESIA AND DIAPHRAGMATICA. THE PROXIMAL LEFT ANTERIOR DESCENDING WAS A 75% ECCENTRIC LESION AND THE MID LEFT ANTERIOR DESCENDING WAS A 90% TUBULAR LESION WITH GOOD DISTAL BED. THE CIRCUMFLEX HAD SUPERPOSED STENTS AT PERMEABLE CIRCUMFLEX WITH 90% STENOSIS DISTAL TO SUCH, WITH GOOD DISTAL CALIBER. THE PROXIMAL RIGHT CORONARY ARTERY WAS LESS THAN 25% CALCIFIED. THE MID RIGHT CORONARY ARTERY HAD A 75% LESION AND OSTARIO OF 90% AT THE POSTERIOR DESCENDING. THE PATIENT UNDERWENT REVASCULARIZATION. A 2.5 X 12MM TAXUS STENT WAS IMPLANTED AT THE PROXIMAL LEFT ANTERIOR DESCENDING AND DISTAL CIRCUMFLEX. A 3.5 X 23MM CYPHER WAS IMPLANTED AT THE RIGHT CORONARY ARTERY. THE PATIENT HAD A TARGET LESION IN THE DISTAL CIRCUMFLEX THAT MEASURED 22MM IN LENGTH. THE LESION WAS PRE-DIALTED WITH A BALLOON AT 10ATMS. A 2.5 X 18MM RAPAMYCIN STENT WAS IMPLANTED AT 12ATMS AND A 3.0 X 8MM RAPAMYCIN STENT THAT WAS IMPLANTED AT 10ATMS PROXIMAL, OVERLAPPING THE FIRST STENT. THE LESION WAS POST-DILATED WITH A BALLOON AT 14ATMS. FINAL TIMI FLOW GRADE WAS 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPAMYCIN CLINICAL 2.5 X 18 MM * NIQ CORDIS EUROPA, N.V. NA R0501334

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R