BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3103121 · Received May 9, 2013

    Report

    Report Number
    9616099-2013-00284
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 18, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT POST-PROCEDURE THE PATIENT HAD LOW BLOOD PRESSURE HE HAD IV FLUID AND LOW DOSE IV DOPAMINE FOR ABOUT 24 HRS. AS REPORTED BY THE SAPPHIRE STUD, A (B)(6) MALE PATIENT WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, DIABETES MELLITUS AND HYPERTENSION, HAD LOW BLOOD PRESSURE POST-PROCEDURE. THE PATIENT WAS TREATED WITH HE HAD IV FLUID AND LOW DOSE IV DOPAMINE FOR ABOUT 24 HRS. ON THE FOLLOWING DAY, THE PATIENT HAD A MYOCARDIAL INFARCTION WITH CK-MB ON THE FOLLOWING DAY WAS 15.6 NG/ML (UPPER LIMIT 6.6). FIRST ENZYME ELEVATION WAS ON THE FOLLOWING DAY AT 0500 AND AS SUCH THE INDEX PROCEDURE WAS ALREADY COMPLETED. CABG WAS ALREADY PLANNED PRIOR TO CAROTID PROCEDURE AND OCCURRED 4 DAYS LATER. THE PATIENT WAS DISCHARGED 8 DAYS LATER. THE PATIENT WAS SYMPTOMATIC AT STUDY INCLUSION WITH BASELINE NIH AND RANKIN SCORES AT 0. CAROTID ARTERY STENTING (CAS) WAS PERFORMED ON A 90% OCCLUDED LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY OF 30MM IN LENGTH IN A 3.65MM VESSEL DIAMETER. THE ARCH I LESION WAS ECCENTRIC AND SEVERELY CALCIFIED. A 6MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION AND IT WAS PRE-DILATED. THEN AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. 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 IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INVASIVE PROCEDURE IN WHICH MEDICAL DEVICES/PRODUCTS ARE INSERTED INTO THE PATIENTS VASCULATURE AND MANIPULATED TO VARYING DEGREES AND IS LISTED IN THE IFU AS SUCH. 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 CAUSAL RELATIONSHIP BETWEEN THE STENT IMPLANTED IN THE CAROTID ARTERY AND THE REPORTED MI. THE INHERENT RISK OF THE PROCEDURE COMBINED WITH THE PATIENT¿S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. HYPOTENSION IS A WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. THE HEMODYNAMIC INSTABILITY THAT OCCURS BOTH DURING AND AFTER CAROTID STENT IMPLANTATION IS INFLUENCED BY THE BARO-RECEPTORS, WHICH ARE LOCATED AT THE CAROTID BIFURCATION. THESE BARO-RECEPTORS ARE STIMULATED BY THE STRETCH OF INTERVENTIONAL BALLOONS, SDS (STENT DELIVERY SYSTEM) AND DISTAL PROTECTION DEVICES, INITIATING A REFLEX VIA THE GLOSSOPHARYNGEAL NERVE. THIS RESULTS IN A FALL IN BLOOD PRESSURE AND BRADYCARDIA. STENT PLACEMENT MAY PROMOTE PERSISTENT STIMULATION OF THESE BARO-RECEPTORS. THESE REACTIONS ARE ANTICIPATED RELATIVELY SHORT-TERM ADVERSE EVENTS ASSOCIATED WITH THE COMPRESSION OF THE BARO-RECEPTORS DURING BALLOON INFLATION, STENT IMPLANTATION AND FILTER DEVICE MANIPULATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS: HEPARIN AND CLOPIDOGREL WERE GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(6), A (B)(6) MALE PATIENT WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, DIABETES MELLITUS AND HYPERTENSION EXPERIENCED A MYOCARDIAL INFARCTION ON THE SAME DAY OF THE INDEX PROCEDURE. CK-MB ON THE FOLLOWING DAY WAS 15.6 NG/ML (UPPER LIMIT 6.6). FIRST ENZYME ELEVATION WAS ON THE FOLLOWING DAY AT 0500 AND AS SUCH THE INDEX PROCEDURE WAS ALREADY COMPLETED. CABG WAS ALREADY PLANNED PRIOR TO CAROTID PROCEDURE AND OCCURRED 4 DAYS LATER. THE PATIENT WAS DISCHARGED 8 DAYS LATER. THE PATIENT WAS SYMPTOMATIC AT STUDY INCLUSION WITH BASELINE NIH AND RANKIN SCORES AT 0. CAROTID ARTERY STENTING (CAS) WAS PERFORMED ON A 90% OCCLUDED LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY OF 30MM IN LENGTH IN A 3.65MM VESSEL DIAMETER. THE ARCH I LESION WAS ECCENTRIC AND SEVERELY CALCIFIED. A 6MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION AND IT WAS PRE-DILATED. THEN AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. 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 IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INVASIVE PROCEDURE IN WHICH MEDICAL DEVICES/PRODUCTS ARE INSERTED INTO THE PATIENTS VASCULATURE AND MANIPULATED TO VARYING DEGREES AND IS LISTED IN THE IFU AS SUCH. 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 CAUSAL RELATIONSHIP BETWEEN THE STENT IMPLANTED IN THE CAROTID ARTERY AND THE REPORTED MI. THE INHERENT RISK OF THE PROCEDURE COMBINED WITH THE PATIENT¿S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THE FIRST PARAGRAPH OF THE PREVIOUS REPORT WAS CORRECTED AND IS HEREIN INCLUDED. THE PREVIOUS CODES REMAIN UNCHANGED. AS REPORTED BY THE (B)(6) STUDY, A (B)(6) MALE PATIENT WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, DIABETES MELLITUS AND HYPERTENSION, HAD LOW BLOOD PRESSURE POST-PROCEDURE. THE PATIENT WAS TREATED WITH IV FLUID AND LOW DOSE IV DOPAMINE FOR ABOUT 24 HRS. ON THE FOLLOWING DAY, THE PATIENT HAD A MYOCARDIAL INFARCTION WITH CK-MB AT15.6 NG/ML (UPPER LIMIT 6.6). FIRST ENZYME ELEVATION WAS ON THE FOLLOWING DAY AT 0500 AND AS SUCH THE INDEX PROCEDURE WAS ALREADY COMPLETED. CABG WAS ALREADY PLANNED PRIOR TO CAROTID PROCEDURE AND OCCURRED 4 DAYS LATER. THE PATIENT WAS DISCHARGED 8 DAYS LATER. THE PATIENT WAS SYMPTOMATIC AT STUDY INCLUSION WITH BASELINE NIH AND RANKIN SCORES AT 0. CAROTID ARTERY STENTING (CAS) WAS PERFORMED ON A 90% OCCLUDED LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY OF 30MM IN LENGTH IN A 3.65MM VESSEL DIAMETER. THE ARCH I LESION WAS ECCENTRIC AND SEVERELY CALCIFIED. A 6MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION AND IT WAS PRE-DILATED. THEN AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. 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 IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INVASIVE PROCEDURE IN WHICH MEDICAL DEVICES/PRODUCTS ARE INSERTED INTO THE PATIENTS VASCULATURE AND MANIPULATED TO VARYING DEGREES AND IS LISTED IN THE IFU AS SUCH. 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 CAUSAL RELATIONSHIP BETWEEN THE STENT IMPLANTED IN THE CAROTID ARTERY AND THE REPORTED MI. THE INHERENT RISK OF THE PROCEDURE COMBINED WITH THE PATIENT¿S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. HYPOTENSION IS A WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. THE HEMODYNAMIC INSTABILITY THAT OCCURS BOTH DURING AND AFTER CAROTID STENT IMPLANTATION IS INFLUENCED BY THE BARO-RECEPTORS, WHICH ARE LOCATED AT THE CAROTID BIFURCATION. THESE BARO-RECEPTORS ARE STIMULATED BY THE STRETCH OF INTERVENTIONAL BALLOONS, SDS (STENT DELIVERY SYSTEM) AND DISTAL PROTECTION DEVICES, INITIATING A REFLEX VIA THE GLOSSOPHARYNGEAL NERVE. THIS RESULTS IN A FALL IN BLOOD PRESSURE AND BRADYCARDIA. STENT PLACEMENT MAY PROMOTE PERSISTENT STIMULATION OF THESE BARO-RECEPTORS. THESE REACTIONS ARE ANTICIPATED RELATIVELY SHORT-TERM ADVERSE EVENTS ASSOCIATED WITH THE COMPRESSION OF THE BARO-RECEPTORS DURING BALLOON INFLATION, STENT IMPLANTATION AND FILTER DEVICE MANIPULATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, INDICATED THAT ON THE SAME DAY OF THE INDEX PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. CK-MB ON THE FOLLOWING DAY WAS 15.6 NG/ML (UPPER LIMIT 6.6). FIRST ENZYME ELEVATION WAS ON THE FOLLOWING DAY AT 0500 AND AS SUCH THE INDEX PROCEDURE WAS ALREADY COMPLETED. CABG WAS ALREADY PLANNED PRIOR TO CAROTID PROCEDURE AND OCCURRED 4 DAYS LATER. THE PATIENT WAS DISCHARGED 8 DAYS LATER. THE PATIENT WAS SYMPTOMATIC AT STUDY INCLUSION WITH BASELINE NIH AND RANKIN SCORES AT 0. CAROTID ARTERY STENTING (CAS) WAS PERFORMED ON A 90% OCCLUDED LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY OF 30MM IN LENGTH IN A 3.65MM VESSEL DIAMETER. THE ARCH I LESION WAS ECCENTRIC AND SEVERELY CALCIFIED. A 6MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION AND IT WAS PRE-DILATED. THEN AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204438 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15802118

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization 6MM ANGIOGUARD EMBOLIC PROTECTION DEVICE