BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2180182 · Received July 27, 2011

    Report

    Report Number
    3003742446-2011-00375
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 27, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT A (B)(6) MALE PATIENT HAD TWO CYPHER STENTS PLACED IN UNSPECIFIED VESSELS FOR AN UNSPECIFIED REASON. THE FOLLOWING YEAR, THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE, WHICH WAS TREATED WITH CLONIDINE. APPROXIMATELY TWO YEARS AND FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED SEVERE CHEST PAIN, WHICH WAS TREATED WITH NITROGLYCERIN AND MORPHINE. APPROXIMATELY FIVE MONTHS LATER, THE PATIENT REPORTED HAVING EXPERIENCED "THREE HEART ATTACKS BECAUSE THE TWO CYPHER STENTS HAD TOTALLY COLLAPSED CLOSING UP HIS ARTERIES". THE PATIENT WAS HOSPITALIZED AND AN ANGIOPLASTY WAS PERFORMED. THE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED SEVEN DAYS LATER. THE PATIENT'S PAST MEDICAL HISTORY IS UNKNOWN. MULTIPLE ATTEMPTS REQUESTING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS HAVE BEEN MADE. THE CARDIOLOGIST OFFICE INDICATED THAT THE PATIENT HAD NOT BEEN EVALUATED IN THEIR OFFICE AND TO FORWARD THE INFORMATION REQUEST TO HIS PRIMARY CARE MANAGER. MULTIPLE ATTEMPTS TO OBTAIN MEDICAL RECORDS FROM THE PRIMARY CARE PHYSICIAN'S OFFICE WERE MADE UNSUCCESSFULLY. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROCESSED ACCORDINGLY. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER OF WAS NOT PROVIDED THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. RESTENOSIS AND MYOCARDIAL INFARCTION ARE A KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE EVENTS REPORTED BY THE PATIENT. NEITHER THE DHR CONDUCTED NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2011-00374 AND 3003742446-2011-00375.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURER REPORT NUMBERS 3003742446-2011-00374 AND 3003742446-2011-00375. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD TWO CYPHER STENTS PLACED IN UNSPECIFIED VESSELS FOR AN UNSPECIFIED REASON. THE FOLLOWING YEAR, THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE, WHICH WAS TREATED WITH CLONIDINE. APPROXIMATELY TWO YEARS AND FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED SEVERE CHEST PAIN, WHICH WAS TREATED WITH NITROGLYCERIN AND MORPHINE. APPROXIMATELY FIVE MONTHS LATER, THE PATIENT EXPERIENCED "THREE HEART ATTACKS," BECAUSE THE TWO CYPHER STENTS HAD TOTALLY COLLAPSED CLOSING UP HIS ARTERIES. ADDITIONALLY, THE PATIENT REPORTED THAT HIS PHYSICIAN STATED "THE HEART ATTACKS WERE THE DIRECT RESULT OF THE STENTS COLLAPSING." THE PATIENT WAS HOSPITALIZED AND AN ANGIOPLASTY WAS PERFORMED. THE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED SEVEN DAYS LATER.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R ASPIRIN AND PLAVIX