BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 3944412 · Received July 18, 2014

    Report

    Report Number
    9616099-2014-00477
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    December 1, 2011
    Report Date
    June 30, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THIS DEVICE. THE CITATION IS AS FOLLOWS: JIANG L., LING, F., LING B., MIAO Z. (2011, DECEMBER). INSIGHT INTO THE PERIPROCEDURAL EMBOLIC EVENTS OF INTERNAL CAROTID ARTERY ANGIOPLASTY A REPORT OF FOUR CASES AND LITERATURE REVIEW. INTERVENTIONAL NEURORADIOLOGY, 17, 452-458. THE EXACT DATE OF PUBLICATION IS UNKNOWN; THEREFORE, THE EVENT DATE WAS ENTERED AS (B)(6) 2011. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00477 & 9616099-2014-00479. CONCOMITANT DEVICES: FILTERWIRE, BOSTON SCIENTIFIC DISTAL PROTECTION DEVICE, UNKNOWN CORDIS BALLOON THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00477 & 9616099-2014-00479. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY JIANG ET AL INSIGHT INTO THE PERIPROCEDURAL EMBOLIC EVENTS OF INTERNAL CAROTID ARTERY ANGIOPLASTY, INTERVENTIONAL NEURORADIOLOGY 17 (2011) 452-458; A (B)(6) MAN WITH A HISTORY OF CORONARY ARTERY DISEASE PRESENTED WITH LEFT HEMIPLEGIA (4/5). THE LABORATORY DATA WERE ALL NORMAL EXCEPT FOR A HIGH LEVEL OF BLOOD GLUCOSE AND PLATELET AGGREGATION RATE. DSA DEMONSTRATED A SEVERE STENOSIS OF THE ORIGIN OF THE RIGHT ICA. UNDER LOCAL ANESTHESIA, AN 8F GUIDING CATHETER WAS INTRODUCED INTO THE RIGHT COMMON CAROTID ARTERY, AND A NON-CORDIS DISTAL PROTECTION DEVICE WAS PLACED BEYOND THE LESION. AFTER PREDILATION WITH A 6×40MM BALLOON (CORDIS) AT 6 ATMOSPHERES, SLOW BLOOD FLOW WAS OBSERVED AND NEAR OCCLUSION DISTAL TO THE LESION. A STENT (10×40 MM, PRECISE, CORDIS) WAS RAPIDLY DEPLOYED AND THE STENOTIC ARTERY WAS RECANALIZED WITHOUT CUT-OFF OF INTRACRANIAL VESSELS ON DSA. THE RETRIEVED PROTECTION FILTER WAS FOUND TO BE FILLED WITH ATHEROSCLEROTIC PARTICLES. AND THE HISTOLOGICAL ANALYSIS DETECTED PARTICULATE, ATHEROMATOUS MATERIAL CHARACTERIZED BY LIPID-RICH MACROPHAGES, FIBRIN MATERIAL, AND CHOLESTEROL CLEFTS. THE PATIENT DEVELOPED 2/5 LEFT ARM AND LEG WEAKNESS, WHICH IMPROVED TO 4/5 OVER 12 DAYS WITHOUT ANY ADDITIONAL TREATMENT. THE DWI AFTER STENTING SHOWED NEW ISCHEMIC LESIONS ON THE IPSILATERAL HEMISPHERE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE FUNCTION OF AN EMBOLIC PROTECTION DEVICE IS TO CAPTURE DEBRIS DURING THE CAROTID PROCEDURE AND PREVENT IT FROM EMBOLIZING DOWNSTREAM INTO THE PATIENTS VASCULATURE. IF ENOUGH DEBRIS IS DISLODGED FROM THE ARTERIAL WALL DURING THE PROCEDURE IT MAY FILL THE FILTER BASKET TO THE POINT AT WHICH IT INTERFERES WITH NORMAL BLOOD FLOW THROUGH THE FILTER RESULTING IN HYPOPERFUSION. THIS IS AN INHERENT RISK OF THE PROCEDURE AND DOES NOT REPRESENT A DEVICE MALFUNCTION. NORMAL BLOOD FLOW TYPICALLY RESUMES UPON REMOVAL OF THE DEVICE OR REMOVAL OF THE DEBRIS IN THE FILTER BY MEANS OF AN ASPIRATION CATHETER. HYPOTENSION, HYPOPERFUSION, CEREBRAL ISCHEMIA AND THE RESULTANT TIA AND ASSOCIATED SYMPTOMS ARE WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. TIA SYMPTOMS ARE SIMILAR TO THOSE OF STROKE BUT DO NOT LAST AS LONG. TYPICALLY SYMPTOMS OF A TIA OFTEN LAST ONLY A FEW MINUTES, MOST SYMPTOMS RESOLVE WITHIN AN HOUR BUT THEY MAY LAST UP TO 24 HOURS. TIA OCCURS WHEN THE BLOOD SUPPLY TO PART OF THE BRAIN IS BRIEFLY INTERRUPTED. 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. CERTAIN FACTORS MAY INFLUENCE THE LIKELIHOOD OF ANTICIPATED BARO-RECEPTOR REACTIONS SUCH AS ADVANCED AGE, VENTRICULAR DYSFUNCTION AND GENDER. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY JIANG ET AL INSIGHT INTO THE PERIPROCEDURAL EMBOLIC EVENTS OF INTERNAL CAROTID ARTERY ANGIOPLASTY, INTERVENTIONAL NEURORADIOLOGY 17 (2011) 452-458; A (B)(6) MAN WITH A HISTORY OF CORONARY ARTERY DISEASE PRESENTED WITH LEFT HEMIPLEGIA (4/5). THE LABORATORY DATA WERE ALL NORMAL EXCEPT FOR A HIGH LEVEL OF BLOOD GLUCOSE AND PLATELET AGGREGATION RATE. DSA DEMONSTRATED A SEVERE STENOSIS OF THE ORIGIN OF THE RIGHT ICA. UNDER LOCAL ANESTHESIA, AN 8F GUIDING CATHETER WAS INTRODUCED INTO THE RIGHT COMMON CAROTID ARTERY, AND A DISTAL PROTECTION DEVICE (FILTERWIRE, BOSTON SCIENTIFIC) WAS PLACED BEYOND THE LESION. AFTER PREDILATION WITH A 6×40MM BALLOON (ANGIOGUARD, CORDIS) AT 6 ATM, SLOW BLOOD FLOW WAS OBSERVED AND NEAR OCCLUSION DISTAL TO THE LESION. A STENT (10×40 MM, PRECISE, CORDIS) WAS RAPIDLY DEPLOYED AND THE STENOTIC ARTERY WAS RECANALIZED WITHOUT CUT-OFF OF INTRACRANIAL VESSELS ON DSA. THE RETRIEVED PROTECTION FILTER WAS FOUND TO BE FILLED WITH ATHEROSCLEROTIC PARTICLES. AND THE HISTOLOGICAL ANALYSIS DETECTED PARTICULATE, ATHEROMATOUS MATERIAL CHARACTERIZED BY LIPID-RICH MACROPHAGES, FIBRIN MATERIAL, AND CHOLESTEROL CLEFTS. THE PATIENT DEVELOPED 2/5 LEFT ARM AND LEG WEAKNESS, WHICH IMPROVED TO 4/5 OVER 12 DAYS WITHOUT ANY ADDITIONAL TREATMENT. THE DWI AFTER STENTING SHOWED NEW ISCHEMIC LESIONS ON THE IPSILATERAL HEMISPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421693 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| S