BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2103363 · Received May 26, 2011

    Report

    Report Number
    9616099-2011-00363
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    January 8, 2011
    Report Date
    June 24, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2011-00362. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2011-00362. THE (B)(6) FEMALE PATIENT WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, ABNORMAL STRESS TEST, CABG, CORONARY ARTERY DISEASE AND HYPERTENSION WAS PART OF THE SAPPHIRE STUDY. AFTER HAVING A CAROTID ENDARTERECTOMY THE PATIENT RECEIVED TWO PRECISE STENTS IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE PROCEDURE WAS COMPLETED WITHOUT MISHAP. TWO DAYS AFTER THE PROCEDURE, THE PATIENT HAD A MYOCARDIAL INFARCTION. THE PATIENT HAD NON-RECONSTRUCTIBLE CORONARY ARTERY DISEASE PRE-OP AND THE MI WAS REPORTED TO BE DUE TO PHYSIOLOGIC STRESS. (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15208970 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15175104 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. MYOCARDIAL INFARCTION (MI) OR ACUTE MYOCARDIAL INFARCTION (AMI), COMMONLY KNOWN AS A HEART ATTACK IS THE INTERRUPTION OF BLOOD SUPPLY TO PART OF THE HEART, CAUSING SOME HEART CELLS TO DIE. THIS IS MOST COMMONLY DUE TO OCCLUSION (BLOCKAGE) OF A CORONARY ARTERY FOLLOWING THE RUPTURE OF A VULNERABLE ATHEROSCLEROTIC PLAQUE, WHICH IS AN UNSTABLE COLLECTION OF LIPIDS (FATTY ACIDS) AND WHITE BLOOD CELLS (ESPECIALLY MACROPHAGES) IN THE WALL OF AN ARTERY. THERE IS NO MEDICAL EVIDENCE TO SUGGEST A RELATIONSHIP BETWEEN CAROTID ARTERY STENT IMPLANTATION AND THE REPORTED MI.

    Description of Event or Problem · 1

    THE (B)(6) FEMALE PATIENT WAS PART OF THE (B)(4) STUDY. THE PATIENT RECEIVED TWO PRECISE STENTS IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. A CAROTID ENDARTERECTOMY WAS DONE PRIOR TO THE PLACEMENT OF THE STENTS. TWO ANGIOGUARD DEVICES WERE USED FOR THE STENTING PROCEDURE. DURING THE PROCEDURE, THE PATIENT COUGHED THE ANGIOGUARDS OUT OF PLACE. THE ANGIOGUARDS WERE RETRIEVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. TWO DAYS AFTER THE PROCEDURE, THE PATIENT HAD AN MI. THE PATIENT HAD NONRECONSTRUCTIBLE CORONARY DISEASE PRE-OP AND THE MI WAS DUE TO PHYSIOLOGIC STRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15208970

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention ASPIRIN, CLOPIDOGREL