BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2820238 · Received November 6, 2012

    Report

    Report Number
    9616099-2012-00648
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    August 11, 2012
    Report Date
    October 10, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT EXACT IMPLANT DATE OF A CYPHER SELECT DEVICE IS UNKNOWN. COMPLAINT CONCLUSION: AS REPORTED FROM THE AFFILIATE, A (B)(6) MALE PATIENT EXPERIENCED STENT FRACTURE INVOLVING RESTENOSIS OF CYPHER SELECT IMPLANTED IN THE LEFT ANTERIOR DESCENDING. AT THE TIME OF INITIAL STENT PLACEMENT, THE LAD WAS DESCRIBED AS 72 MM IN LENGTH AND CLASS C. THE INDICATION FOR THE PROCEDURE WAS REPORTED AS UNSTABLE ANGINA PECTORIS. THE LESION WAS TREATED WITH A 2.75 X 18 MM CYPHER SELECT AT 14 ATMS. IT WAS UNKNOWN HOW MANY STENTS (UNKNOWN BRANDS) WERE IMPLANTED; HOWEVER IT WAS REPORTED THAT AN UNKNOWN STENT WAS IMPLANTED OVERLAPPING THE INITIAL CYPHER SELECT STENT. NO FURTHER INFO IS AVAILABLE. AFTER UNSPECIFIED TIME, THE PATIENT RETURNED WITH STABLE ANGINA PECTORIS AND THE IMPLANTED CYPHER SELECT WAS DIAGNOSED TO BE FRACTURED. THE TYPE OF FRACTURE WAS "P". THIS WAS TREATED WITH A POBA. NO ADDITIONAL INFORMATION IS AVAILABLE. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE HAS BEEN NO STERILE LOT NUMBER INFORMATION AVAILABLE TO DATE THUS NO DHR COULD BE PERFORMED. STENT FRACTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CYPHER STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE ARE MULTIPLE FACTORS THAT CAN CONTRIBUTE TO STENT FRACTURE IN THE CORONARY ARTERIES. THE CORONARY ARTERIES ARE VERY DYNAMIC VESSELS THAT UNDERGO BIOMECHANICAL FORCES SUCH AS FLEXION, TORSION, COMPRESSION, AND ELONGATION. STUDIES HAVE ALSO REVEALED THAT STENT FRACTURES OCCUR IN CASES OF MULTIPLE STENTS AND OVERLAP RELATED TO AN ABNORMAL STRESS AREA THAT IS CREATED. 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. IN THIS CASE, VESSEL/LESION CHARACTERISTICS, PROCEDURAL FACTORS AND/OR BIOMECHANICAL FORCES LIKELY CONTRIBUTED TO THE REPORTED 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 (B)(4) FROM (B)(4) 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; IE, HYPERTENSION AND SMOKING.

    Description of Event or Problem · 1

    AS REPORTED FROM THE AFFILIATE, A (B)(6) MALE PATIENT EXPERIENCED STENT FRACTURE INVOLVING RESTENOSIS OF CYPHER SELECT IMPLANTED IN THE LEFT ANTERIOR DESCENDING. AT THE TIME OF INITIAL STENT PLACEMENT, THE LAD WAS DESCRIBED AS 72 MM IN LENGTH AND CLASS C. THE INDICATION FOR THE PROCEDURE WAS REPORTED AS UNSTABLE ANGINA PECTORIS. THE LESION WAS TREATED WITH A 2.75 X 18 MM CYPHER SELECT AT 14 ATMS. IT WAS UNKNOWN HOW MANY STENTS (UNKNOWN BRANDS) WERE IMPLANTED; HOWEVER IT WAS REPORTED THAT AN UNKNOWN STENT WAS IMPLANTED OVERLAPPING THE INITIAL CYPHER SELECT STENT. NO FURTHER INFO IS AVAILABLE. AFTER UNSPECIFIED TIME, THE PATIENT RETURNED WITH STABLE ANGINA PECTORIS AND THE IMPLANTED CYPHER SELECT WAS DIAGNOSED TO BE FRACTURED. THE TYPE OF FRACTURE WAS "P". THIS WAS TREATED WITH A POBA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention