BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 2123478 · Received June 14, 2011

    Report

    Report Number
    9616099-2011-00417
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    January 1, 2007
    Report Date
    May 18, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EXACT DATES FOR THE INDEX PROCEDURE AND EVENT DATE ARE NOT KNOWN-ONLY THE YEAR FOR EACH WAS PROVIDED. THE DATE WAS DEFAULTED TO THE FIRST MONTH AND FIRST DAY OF THE MONTH FOR EACH FOR REPORTING PURPOSES. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE MEDICAL AFFAIRS DEPARTMENT INDICATED THAT THE PATIENT CALLED TO INQUIRE ABOUT THE SAFETY OF HAVING AN MRI EXAM IN RELATION TO A PREVIOUSLY IMPLANTED PRECISE 8 X 40 STENT IN THE RIGHT CAROTID ARTERY. THE PATIENT HAD THE PRECISE 8 X 40 STENT IMPLANTED TWO YEARS AFTER EXPERIENCING A MILD HEART ATTACK. APPROXIMATELY THREE YEARS AFTER IMPLANTATION OF THE PRECISE STENT, THE PATIENT EXPERIENCED TIGHTNESS UP AND DOWN HIS THROAT. A BRUIT WAS NOTED ON A PHYSICAL EXAMINATION AND AN ULTRASOUND WAS PERFORMED WHICH INDICATED THAT THE PRECISE STENT HAD RESTENOSED. THE PATIENT WAS HOSPITALIZED AND HAD AN ADDITIONAL NON-CORDIS STENT IMPLANTED INSIDE THE PRECISE STENT TO TREAT THE RESTENOSIS. THE PATIENT'S MEDICAL HISTORY INCLUDES: MILD HEART ATTACK, CANCER AT THE BASE OF THE TONGUE, REMOVAL OF LYMPH NODES, TROUBLE SWALLOWING, PAIN BEHIND RIGHT EAR, VERTEBRAE COMPRESSION FRACTURES AND UNSPECIFIED ULCER. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE MEDICAL AFFAIRS DEPARTMENT INDICATED THAT THE PATIENT CALLED TO INQUIRE ABOUT THE SAFETY OF HAVING AN MRI EXAM IN RELATION TO A PREVIOUSLY IMPLANTED PRECISE 8 X 40 STENT IN THE RIGHT CAROTID ARTERY. THE PATIENT HAD THE PRECISE 8 X 40 STENT IMPLANTED TWO YEARS AFTER EXPERIENCING A MILD HEART ATTACK. APPROXIMATELY THREE YEARS AFTER IMPLANTATION OF THE PRECISE STENT, THE PATIENT EXPERIENCED TIGHTNESS UP AND DOWN HIS THROAT. A BRUIT WAS NOTED ON A PHYSICAL EXAMINATION AND AN ULTRASOUND WAS PERFORMED WHICH INDICATED THAT THE PRECISE STENT HAD RESTENOSED. THE PATIENT WAS HOSPITALIZED AND HAD AN ADDITIONAL NON-CORDIS STENT IMPLANTED INSIDE THE PRECISE STENT TO TREAT THE RESTENOSIS. DURING THE CONVERSATION, THE PATIENT ALSO RELATED SEVERAL ADDITIONAL ADVERSE MEDICAL EVENTS THAT WERE CAPTURED AS NON-COMPLAINTS INCLUDING: PROSTATE CANCER, PROBLEMS WITH HIS NERVE RESPONSES AND MUSCLE REFLEXES, AND BLADDER TROUBLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R