BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2081636 · Received May 9, 2011

    Report

    Report Number
    9616099-2011-00311
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 12, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1016427-2011-00038 AND # 9616099-2011-00311.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE FOR A PRECISE 7 X 30 CAROTID STENT IMPLANTATION THE PATIENT EXPERIENCED HYPOTENSION. THE HYPOTENSION WAS TREATED BY IV INFUSION OF ONE LITER OF CRYSTALLOID AND A PHENYLEPHRINE DRIP TO MAINTAIN A BLOOD PRESSURE ABOVE EIGHTY SYSTOLIC. THE PATIENT HAD NO REPORTED NEUROLOGICAL DEFICIT POST-PROCEDURE. THE PHYSICIAN USED A 5 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE FOR THE PROCEDURE AND THE DEVICE BECAME STRETCHED. THE PATIENT WAS ASYMPTOMATIC FOR THE STUDY INDEX PROCEDURE. THE TARGET LESION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY (RICA). THE LESION WAS REPORTED TO BE: 15 MM LENGTH, AN 81% STENOSIS, 4.5 MM REFERENCE DIAMETER, AND ABSENT OF THROMBUS. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE PATIENT'S MEDICAL HISTORY INCLUDES: CLINICAL COPD, HISTORY OF SMOKING, DIABETES MELLITUS, CORONARY ARTERY DISEASE AND HYPERTENSION. HIGH RISK CRITERIA: PREVIOUS CEA WITH RECURRENT STENOSIS. (B)(4): THE PRODUCT WAS NOT RETURNED FOR INSPECTION. 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 15290513 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. HEMODYNAMIC DEPRESSION DURING CAROTID ARTERY STENTING PROCEDURES IS A COMMON EVENT AND IS MOST LIKELY RELATED TO CORONARY SINUS REFLEX OR VAGAL RESPONSE. THE VAGUS NERVE ENTERS THE THORAX BETWEEN COMMON CAROTID ARTERY AND SUBCLAVIAN ARTERY AND DESCENDS DOWNWARD. DURING BALLOON INFLATION OR STENT DEPLOYMENT, PRESSURE CAN BE EXERTED ON THE NERVE STIMULATING A PARASYMPATHETIC RESPONSE, I.E. BRADYCARDIA, HYPOTENSION, HEART BLOCK, ASYSTOLE, ETC. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR DEFECT OF THE DEVICE, BUT IS LIKELY RELATED TO VESSEL CHARACTERISTICS, THE PATIENT'S SIGNIFICANT MEDICAL HISTORY/HIGH RISK CRITERIA AND PROCEDURAL FACTORS. 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. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT #1016427-2011-00038 AND # 9616099-2011-00311.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE FOR A PRECISE 7 X 30 CAROTID STENT IMPLANTATION THE PATIENT EXPERIENCED HYPOTENSION. THE HYPOTENSION WAS TREATED BY IV INFUSION OF ONE LITER OF CRYSTALLOID AND A PHENYLEPHRINE DRIP TO MAINTAIN A BLOOD PRESSURE ABOVE EIGHTY SYSTOLIC. THE PATIENT HAD NO REPORTED NEUROLOGICAL DEFICIT POST-PROCEDURE. THE PHYSICIAN USED A 5 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE FOR THE PROCEDURE AND THE DEVICE BECAME STRETCHED. ANOTHER ANGIOGUARD WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS ASYMPTOMATIC FOR THE STUDY INDEX PROCEDURE. THE TARGET LESION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY (RICA). THE LESION WAS REPORTED TO BE: 15 MM LENGTH, AN 81% STENOSIS, 4.5 MM REFERENCE DIAMETER, AND ABSENT OF THROMBUS. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 0%.

    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 15290513

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 5 MM ANGIOGUARD RX