BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2081545 · Received May 9, 2011

    Report

    Report Number
    9616099-2011-00308
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: ASPIRIN AND CLOPIDOGREL WERE ADMINISTERED PRE AND POST-PROCEDURE AS WELL AS AT DISCHARGE. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE DISCHARGE FORM WAS RECEIVED AND THE DISCHARGE DATE WAS ON (B)(6) 2011. ASPIRIN AND CLOPIDOGREL WERE ADMINISTERED PRE AND POST-PROCEDURE AS WELL AS AT DISCHARGE. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. NIH STROKE SCALE AND SCORE WERE 0, RESPECTIVELY. THE PATIENT WAS DISCHARGED WITH A MAJOR ADVERSE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AND NO FURTHER REPORTS WILL BE FORTHCOMING FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: ANGIOGUARD RX EMBOLIC PROTECTION DEVICE CATALOG NUMBER 601814RMC, LOT NUMBER 71210506 CONCOMITANT MEDICATIONS ARE CURRENTLY NOT KNOWN. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A (B)(6) MALE PATIENT ENROLLED IN THE STUDY WITH MEDICAL HISTORY INCLUDING FIRST-DEGREE RELATIVE WITH PREMATURE CAD (FEMALE 5PACKS OF CIGARETTES) AND DIABETES MELLITUS. PTA WAS PERFORMED ON A LESION IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID THAT WAS SUCCESSFULLY TREATED WITH A 6MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE AND DEPLOYMENT OF A 9X40MM PRECISE PRO STENT. APPROXIMATELY FIVE (5) DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. PATIENT HAD PCI AND STENT OF THE LEFT MAIN TRUNK AND PROXIMAL LAD ON (B)(6) 2011 THEN REPEAT LEFT HEART CATH WITH PCI AND STENTING OF A PROXIMAL RCA LESION. THE PATIENT WAS DISCHARGED 9 DAYS LATER. THE EVENT WAS CLASSIFIED AS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THERE IS NO MEDICAL EVIDENCE THAT THIS EVENT WAS RELATED TO THE STUDY DEVICE AND IS ATTRIBUTED TO CARDIAC CAUSES. THEREFORE, THIS EVENT WILL BE CLASSIFIED AS A NON-COMPLAINT AND PROCESSED ACCORDINGLY. 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 15007526 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MI IS A WELL-KNOWN DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU AS SUCH. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE THE PATIENT'S PRE-EXISTING SIGNIFICANT CARDIAC HISTORY, PROCEDURAL, PHARMACOLOGICAL AND LESION. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE DEVICE OR THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FROM THE (B)(4) STUDY INDICATED THAT APPROXIMATELY FIVE (5) DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. TOTAL CK-MB WAS 164 (UNL 5.0 NG/ML) AND CK 1779 (UPPER LIMIT 397). CORONARY ANGIOGRAPHY WAS PERFORMED. PATIENT HAD PCI AND STENT OF THE LEFT MAIN TRUNK AND PROXIMAL LAD ON (B)(6) 2011 THEN REPEAT LEFT HEART CATH WITH PCI AND STENTING OF A PROXIMAL RCA LESION. THE PATIENT WAS DISCHARGED 9 DAYS LATER. THE EVENT WAS CLASSIFIED AS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. AT BASELINE THE NIH STOKE SCALE SCORE WAS 0. PTA WAS PERFORMED ON A 95% OCCLUDED LESION IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID OF 24MM IN LENGTH IN A 5.5MM VESSEL DIAMETER. THE ARCH I LESION WAS ULCERATED. A 6MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED AND THE LESION WAS PRE-DILATED, FOLLOWED BY DEPLOYMENT OF A 9X40MM PRECISE PRO RX STENT. THE RESIDUAL DIAMETER STENOSIS MEASURED 15%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED. THE PATIENT HAD NO NEUROLOGICAL DEFICITS UPON LEAVING THE ANGIO SUITE.

    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 15007526

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R