BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER CLINICAL 3.0 X 23MM

    MDR report key: 741508 · Received July 28, 2006

    Report

    Report Number
    9610978-2006-00277
    Event Type
    Injury
    Date Received
    July 28, 2006
    Date of Event
    January 21, 2006
    Report Date
    July 25, 2006
    Manufacturer
    CORDIS RODEN
    Product Code
    NIQ
    PMA / PMN Number
    na
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE FOR ANALYSIS; A REVIEW OF THE MANUFACTURING ROUTE SHEETS CONFIRMED THAT THIS PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. PLEASE NOTE, THIS REPORT REFLECT TWO PRODUCTS WITH THE SAME CATALOG AND LOT NUMBER. THE DEVICE IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US PRODUCT. THIS IS AN INITIAL/FINAL REPORT. PLEASE NOTE THE FOLLOWING FINAL ASPECTS ON THE FILE: IN SUMMARY, THIS MALE PATIENT WITH A HISTORY OF MI, PRIOR STENT PLACEMENT, HTN, HIGH CHOLESTEROL AND SMOKING HAD CYPHER STENT IMPLANTATION. THESE ARE PRE-MORBID CONDITIONS WHICH INCREASE THE RISK FOR A MACE. THE LESION LOCATED IN THE PROXIMAL LAD WAS AN INSTENT RESTENOSIS OF PREVIOUSLY PLACED STENT AND GREATER THAN 40MM LONG. THE CYPHER STENT IS INDICATED FOR DISCRETE DE NOVO LESIONS AND LESIONS OF LENGTH OF 30MM OR LESS. THE LESION WAS PRE-DILATED. TWO CYPHER STENTS 3.0MM X 23MM WERE DEPLOYED COVERING THE PREVIOUSLY PLACED STENT. A DISSECTION WAS NOTED AT THE DISTAL EDGE OF THE STENTED SEGMENT AND WAS TREATED WITH ANOTHER CYPHER STENT. THE SAFETY AND EFFECTIVENESS OF PLACING MORE THAN TWO CYPHER STENTS IN THE PATIENT HAS NOT BEEN ESTABLISHED. APPROXIMATELY 35 MONTHS LATER, CAG REVEALED A 90% RESTENOSIS WITHIN THE PROXIMAL LAD, A 60% STENOSIS IN THE FIRST OM, AND A 70% STENOSIS IN THE PDA. THIS WAS TREATED WITH CABG 10 DAYS LATER. IN CONCLUSION, THERE ARE PATIENT, LESION, AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #'S: 9610978-2006-00277 AND -00278.

    Description of Event or Problem · 1

    THIS PATIENT WAS ADMITTED TO THE HOSPITAL FOR CORONARY INTERVENTION OF AN 85%, LONG (40MM), ECCENTRIC, SMOOTH, INSTENT RESTENOSIS IN THE PROXIMAL LAD. SEVENTY-FIVE HUNDRED UNITS OF HEPARIN WERE ADMINISTERED VIA IV. THE LESION WAS PREDILATED WITH A 2.5 X 20 AQUA T3 BALLOON, A 2.0 X 20 CROSSSAIL BALLOON, AND A 3.0 X 20MM AQUA T3 BALLOON. TWO 3.0 X 23MM CYPHER STENTS WERE DEPLOYED WITHIN THE LESION AND COVERING THE PREVIOUS STENT. FOLLOWING STENT DEPLOYMENT, A TYPE A DISSECTION WAS NOTED AT THE DISTAL EDGE OF THE STENTED SEGMENT. THIS WAS TREATED WITH THE PLACEMENT OF A 2.5 X 8MM CYPHER STENT. POST PROCEDURAL STENOSIS WAS 0%. CK AND CK-MB VALUES MEASURED UP TO 24 HOURS POST PROCEDURE WERE WITHIN NORMAL LIMITS. THE PATIENT WAS DISCHARGED AFTER TWO DAYS WITH ORDERS FOR ASPIRIN, TICLID, BETA-BLOCKERS, ACE INHIBITORS, STATINS, AND OMERPRAZOLE. APPROXIMATELY 35 MONTHS LATER, THE PATIENT RETURNED TO THE HOSPITAL FOR UNSTABLE ANGINA. AFTER ONE WEEK, THE PATIENT WAS TAKEN FOR ANGIOGRAPHIC EVALUATION, WHICH REVEALED A 90% RESTENOSIS WITHIN THE PROXIMAL LAD, A 60% STENOSIS IN THE FIRST OM, AND A 70% STENOSIS IN THE PDA. BASED ON THE FINDINGS, THE PATIENT WAS TAKEN FOR CORONARY BYPASS SURGERY 10 DAYS LATER. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION FIVE DAYS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER CLINICAL 3.0 X 23MM DRUG-ELUTING STENT NIQ CORDIS RODEN NA S0902023

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R TICLID| ACE INHIBITOR NOS| ASPIRIN| OMEPRAZOLE| BETA BLOCKING AGENTS| HMG COA REDUCTASE INHIBITORS| HEPARIN