BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2062832 · Received April 19, 2011

    Report

    Report Number
    9616099-2011-00258
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    December 8, 2010
    Report Date
    March 25, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN.

    Additional Manufacturer Narrative · 1

    THE EMAIL RECEIVED FOR THE (B)(4) STUDY INDICATED THAT TWENTY-FOUR HOURS POST INDEX PROCEDURE THE PATIENT SUFFERED A MYOCARDIAL INFARCTION. THE PATIENT IS A (B)(6) MALE WHO WAS ENROLLED IN THE (B)(4) STUDY FOR STENTING OF CAROTID ARTERY. MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, CONGESTIVE HEART FAILURE, DIABETES MELLITUS, OBESITY AND HYPERTENSION. THE TARGET LESION WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (L5). THE RATE OF STENOSIS WAS 90%. THE VESSEL CHARACTERISTICS ARE UNKNOWN. THE LESION WAS PRE-DILATED. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS USED IN THE PROCEDURE AND A PRECISE STENT WAS DEPLOYED IN THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE DAY AFTER THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A NON Q-WAVE MYOCARDIAL INFARCTION. THE PATIENT'S POSTOPERATIVE COURSE WAS COMPLICATED WITH ASPIRATION PNEUMONIA AND RESPIRATORY FAILURE NECESSITATING INTUBATION AND MECHANICAL VENTILATION AND PRESSOR SUPPORT WITH LEVOPHED. HIS TROPONIN PEAKED AT 57.9 WITH NO EKG CHANGES. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. 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. 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. PLEASE NOTE THAT THE PATIENTS CORRECT DATE OF BIRTH IS (B)(6).

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FOR THE (B)(4) STUDY INDICATED THAT TWENTY-FOUR HOURS POST INDEX PROCEDURE THE PATIENT SUFFERED A MYOCARDIAL INFARCTION. THE PATIENT IS A (B)(6) MALE WHO WAS ENROLLED IN THE (B)(4) STUDY FOR STENTING OF CAROTID ARTERY. MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, CONGESTIVE HEART FAILURE, DIABETES MELLITUS, AND HYPERTENSION. THE PATIENT WEIGHED (B)(6). THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2010. THE TARGET LESION WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (L5). THE RATE OF STENOSIS WAS 90%. THE VESSEL CHARACTERISTICS ARE UNKNOWN. THE LESION WAS PRE-DILATED. AN ANGIOGUARD (701814RMC/ LOT 70710509) DISTAL PROTECTION DEVICE WAS USED IN THE PROCEDURE AND A PRECISE (PC0930RXC/ LOT 15073017) STENT WAS DEPLOYED IN THE LESION. THERE WERE NO TECHNICAL PROBLEMS WITH THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE DAY AFTER THE INDEX PROCEDURE THE PATIENT WAS DIAGNOSED WITH A NON Q-WAVE MYOCARDIAL INFARCTION. THE PATIENTS POSTOPERATIVE COARSE WAS COMPLICATED WITH ASPIRATION PNEUMONIA AND RESPIRATORY FAILURE NECESSITATING INTUBATION AND MECHANICAL VENTILATION AND PRESSOR SUPPORT WITH LOVOPHED. HIS TROPONIN PEAKED AT 57.9 WITH NO EKG CHANGES. THE PATIENT ALSO DEVELOPED UPPER GI BLEED AND REQUIRED TRANSFUSIONS. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT.

    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 15073017

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R ANGIOGUARD RX (LOT# 70710509, CAT# 701814RMC)