BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 3905458 · Received July 1, 2014

    Report

    Report Number
    9616099-2014-00441
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    October 1, 2010
    Report Date
    June 10, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PULSE RATE WAS INCREASED BY IV ADMINISTRATION OF 0.5MG ATROPINE IN 1ML OF SALINE, THE TARGET LESION WAS PREDILATED WITH 3.4- TO 4.0-MM-DIAMETER ANGIOPLASTY BALLOONS. PRECISE SELF-EXPANDING STENTS WERE IMPLANTED, COVERING THE CAROTID BIFURCATION. ALL STENTS WERE POSTDILATED WITH 4.5- TO 6.0-MM-DIAMETER BALLOONS AT 10 ATMOSPHERES. AFTER POSTDILATION, AN ASPIRATION METHOD WAS ROUTINELY PERFORMED IN EVERY CASE REGARDLESS OF THE ANGIOGRAPHIC FLOW STATE. A 7-F ELIMINATE ASPIRATION CATHETER OR A 7-F THROMBUSTER 3 CATHETER WITH A 30-ML VACUUM SYRINGE WAS ADVANCED TOWARD THE FILTER; BOTH CATHETERS HAD DISTAL TIP DIAMETERS OF 1.25MM. THE TIP OF THE ASPIRATION CATHETER WAS LOCATED JUST PROXIMAL TO THE ANGIOGUARD XP. APPROXIMATELY 20ML OF BLOOD WAS ASPIRATED AND THEN PASSED THROUGH A CELL STRAINER. THE OPERATOR INSPECTED THE CELL STRAINER TO EVALUATE THE MACROSCOPIC DEBRIS PRESENT. THIS PROCEDURE WAS REPEATED AT LEAST 5 TIMES OR UNTIL ALMOST NO DEBRIS WAS OBSERVED MACROSCOPICALLY IN THE CELL STRAINER. FINALLY, A RETRIEVAL SHEATH WAS ADVANCED, AND THE FILTER WAS CLOSED AND REMOVED FROM THE ARTERY. THE REPEATED BLOOD ASPIRATIONS TOOK 3 TO 5 MINUTES FROM POSTDILATION TO THE REMOVAL OF THE FILTER. ANGIOGRAPHY WAS SYSTEMATICALLY PERFORMED TO ASSESS FLOW AFTER EACH STEP OF THE PROCEDURE: FILTER DEVICE PLACEMENT, PREDILATION, STENT PLACEMENT, POSTDILATION, ASPIRATION OF THE BLOOD COLUMN, AND FILTER RETRIEVAL. THE OPERATORS CLASSIFIED BLOOD FLOW IMMEDIATELY BEFORE FILTER RETRIEVAL AS NORMAL, SLOW, OR STOPPED. STOPPED FLOW WAS DEFINED AS ANTEGRADE FLOW CESSATION, WHILE SLOW FLOW WAS DEFINED AS NEW AND DEFINITE FLOW IMPAIRMENT COMPARED WITH THE FLOW IN THE EXTERNAL CAROTID ARTERY.2 IN ADDITION TO PROSPECTIVE DATA COLLECTION ON THE INCIDENCE OF FLOW IMPAIRMENT, ALL ANGIOGRAMS WERE REVIEWED RETROSPECTIVELY BY THE EXPERIENCED INTERVENTIONISTS TO QUALITATIVELY ASSESS FLOW IN THE ICA. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THIS DEVICE. THE CITATION IS AS FOLLOWS: SORIMACHI, T ET AL. (2010, OCTOBER). OBSTRUCTION OF PORES IN DISTAL PROTECTION FILTERS AND ANGIOGRAPHICALLY-DOCUMENTED FLOW IMPAIRMENT DURING CAROTID ARTERY STENTING, J ENDOVASC THERAPY, 17, 661-670. THE EXACT DATE OF PUBLICATION IS UNKNOWN; THEREFORE, THE EVENT DATE WAS PROVIDED AS (B)(6) 2010. THE GENDER OF THE PATIENT IS UNKNOWN. CONCOMITANT MEDICATIONS: HEPARIN AND ATROPINE WERE GIVEN DURING THE PROCEDURE. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND/OR CILOSTAZOL. THIS IS THE INITIAL AND FINAL REPORT FOR THIS DEVICE. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY SORIMACHI ET AL OBSTRUCTION OF PORES IN DISTAL PROTECTION FILTERS AND ANGIOGRAPHICALLY-DOCUMENTED FLOW IMPAIRMENT DURING CAROTID ARTERY STENTING, J ENDOVASC THERAPY 17 (2010) 661-670; A PATIENT WITH NORMAL FLOW DEVELOPED HYPERPERFUSION SYNDROME WITH A MINOR VISUAL FIELD DEFECT 2 DAYS AFTER THE PROCEDURE. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO DETERMINE ANY RELATIONSHIP BETWEEN ANGIOGRAPHICALLY DOCUMENTED FLOW IMPAIRMENT ASSOCIATED WITH THE ANGIOGUARD XP CEREBRAL PROTECTION FILTER DURING CAROTID ARTERY STENTING (CAS) AND THE CONDITION OF THE PORES IN THE RETRIEVED FILTER. ANGIOGUARD XP FILTERS WERE RETRIEVED FROM 54 CONSECUTIVE PATIENTS (50 MEN; MEAN AGE WAS 71 YEARS, RANGE 53-83) WHO UNDERWENT 56 FILTER-PROTECTED CAS PROCEDURES (2 BILATERAL) UNDER AN APPROVED TREATMENT PROTOCOL. CAS WAS OFFERED TO PATIENTS WITH AN ASYMPTOMATIC CAROTID ARTERY STENOSIS GREATER THAN OR EQUAL TO 80% OR A SYMPTOMATIC CAROTID ARTERY STENOSIS GREATER THAN OR EQUAL TO 50% PATIENTS WITH A HISTORY OF A DISABLING STROKE WERE NOT ELIGIBLE FOR CAS. IN THIS COHORT, 39 LESIONS WERE SYMPTOMATIC AND 17 LESIONS WERE ASYMPTOMATIC. THE CAROTID ARTERY STENOSIS, WHICH AVERAGED 76.1% (RANGE 50%-99%), WAS LOCATED ON THE RIGHT IN 27 CASES AND ON THE LEFT IN 29. ANTIPLATELET THERAPY CONSISTING OF ASPIRIN (100MG/D) AND CLOPIDOGREL (75MG/D) OR CILOSTAZOL (200 MG/D) WAS STARTED AT LEAST 5 DAYS BEFORE THE PROCEDURE. ANGIOGRAPHY WAS PERFORMED USING HAND-INJECTED IOXAGLIC ACID AS THE CONTRAST MEDIUM. DSA IMAGES (3 FRAMES/S) WERE OBTAINED ON THE AXION ARTIS SYSTEM. PERCUTANEOUS ACCESS WAS GAINED THROUGH THE FEMORAL ARTERY. HEPARIN WAS GIVEN IV TO MAINTAIN AN ACTIVATED CLOTTING TIME (ACT) >2 TIMES BASELINE, WITH A TARGET OF AT LEAST 300 SECONDS. STENOSES WERE CROSSED WITH 5-,6-, OR 7-MM-DIAMETER ANGIOGUARD XP FILTERS SELECTED TO BE 0.5 TO 1.5MM LARGER THAN THE DISTAL VESSEL DIAMETER AS MEASURED ON DSA. AFTER THE PULSE RATE WAS INCREASED BY IV ADMINISTRATION OF 0.5MG ATROPINE IN 1ML OF SALINE, THE TARGET LESION WAS PREDILATED WITH 3.4- TO 4.0-MM-DIAMETER ANGIOPLASTY BALLOONS. PRECISE SELF-EXPANDING STENTS WERE IMPLANTED, COVERING THE CAROTID BIFURCATION. ALL STENTS WERE POSTDILATED WITH 4.5- TO 6.0-MM-DIAMETER BALLOONS AT 10 ATMOSPHERES. AFTER POSTDILATION, AN ASPIRATION METHOD WAS ROUTINELY PERFORMED IN EVERY CASE REGARDLESS OF THE ANGIOGRAPHIC FLOW STATE. A 7-F ELIMINATE ASPIRATION CATHETER OR A 7-F THROMBUSTER 3 CATHETER WITH A 30-ML VACUUM SYRINGE WAS ADVANCED TOWARD THE FILTER; BOTH CATHETERS HAD DISTAL TIP DIAMETERS OF 1.25MM. THE TIP OF THE ASPIRATION CATHETER WAS LOCATED JUST PROXIMAL TO THE ANGIOGUARD XP. APPROXIMATELY 20ML OF BLOOD WAS ASPIRATED AND THEN PASSED THROUGH A CELL STRAINER. THE OPERATOR INSPECTED THE CELL STRAINER TO EVALUATE THE MACROSCOPIC DEBRIS PRESENT. THIS PROCEDURE WAS REPEATED AT LEAST 5 TIMES OR UNTIL ALMOST NO DEBRIS WAS OBSERVED MACROSCOPICALLY IN THE CELL STRAINER. FINALLY, A RETRIEVAL SHEATH WAS ADVANCED, AND THE FILTER WAS CLOSED AND REMOVED FROM THE ARTERY. THE REPEATED BLOOD ASPIRATIONS TOOK 3 TO 5 MINUTES FROM POSTDILATION TO THE REMOVAL OF THE FILTER. ANGIOGRAPHY WAS SYSTEMATICALLY PERFORMED TO ASSESS FLOW AFTER EACH STEP OF THE PROCEDURE: FILTER DEVICE PLACEMENT, PREDILATION, STENT PLACEMENT, POSTDILATION, ASPIRATION OF THE BLOOD COLUMN, AND FILTER RETRIEVAL. THE OPERATORS CLASSIFIED BLOOD FLOW IMMEDIATELY BEFORE FILTER RETRIEVAL AS NORMAL, SLOW, OR STOPPED. STOPPED FLOW WAS DEFINED AS ANTEGRADE FLOW CESSATION, WHILE SLOW FLOW WAS DEFINED AS NEW AND DEFINITE FLOW IMPAIRMENT COMPARED WITH THE FLOW IN THE EXTERNAL CAROTID ARTERY. IN ADDITION TO PROSPECTIVE DATA COLLECTION ON THE INCIDENCE OF FLOW IMPAIRMENT, ALL ANGIOGRAMS WERE REVIEWED RETROSPECTIVELY BY THE EXPERIENCED INTERVENTIONISTS TO QUALITATIVELY ASSESS FLOW IN THE ICA. NO FURTHER INFORMATION COULD BE OBTAINED. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. NUMEROUS REPORTS HAVE SUBSEQUENTLY DOCUMENTED THE RISK OF HYPERPERFUSION SYNDROME AFTER CAROTID ENDARTERECTOMY, AFTER CAROTID ANGIOPLASTY AND AFTER INTRACRANIAL ANGIOPLASTY. IT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CAROTID STENT IMPLANTATION AND IS LISTED IN THE IFU AS SUCH. AFTER REVASCULARIZATION THAT ALLEVIATES A HIGH-GRADE SYMPTOMATIC STENOTIC LESION, CEREBRAL HYPERPERFUSION SYNDROME (CHS) MAY OCCUR AS A RESULT OF A SUDDEN, RAPID INCREASE IN CEREBRAL BLOOD FLOW EXCESS OF THAT REQUIRED TO MEET METABOLIC DEMANDS. THERE ARE VARIOUS FACTORS IMPLICATED AS PLAYING A ROLE IN CHS, SUCH AS CEREBRAL AUTOREGULATION, HYPERTENSION, ISCHEMIA REPERFUSION INJURY, INTRAOPERATIVE ISCHEMIA, OXYGEN DERIVED FREE RADICALS AND BARORECEPTOR DYSFUNCTION. TRANSIENT CEREBRAL HYPEREMIA CAN LEAD TO SEVERE UNILATERAL HEADACHE, FACE AND EYE PAIN, CONFUSION, SEIZURES, FOCAL NEUROLOGIC DEFICITS, AND INTRACEREBRAL HEMORRHAGES. TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POSTOPERATIVE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED 3 WEEKS AFTER REVASCULARIZATION. ANTICOAGULATION IS A KNOWN RISK FACTOR FOR BRAIN HEMORRHAGE IN PATIENTS WITH PRE-EXISTING DISEASE. THE USE OF TPA ALSO PUTS THE PATIENT AT A HIGHER RISK FOR EXPERIENCE A HEMORRHAGIC STROKE. EVIDENCE FROM OBSERVATIONAL STUDIES, IN LACK OF RANDOMIZED TRIALS, SUGGESTS THAT A NUMBER OF FACTORS-ALL REFERABLE TO HEMODYNAMIC EXHAUSTION OF THE CEREBRAL CIRCULATION-PLAY A ROLE, SUCH AS RECENT STROKE, SURGERY FOR VERY TIGHT INTERNAL CAROTID ARTERY STENOSIS, CONCOMITANT CONTRALATERAL TIGHT LESION, IMPAIRED CEREBROVASCULAR RESERVE (CEREBRAL HYPOPERFUSION), AND MARKED POSTOPERATIVE INCREASE OF IN IPSILATERAL PEAK MIDDLE CEREBRAL ARTERY FLOW VELOCITY IN ADDITION TO PRE- AND POSTOPERATIVE HYPERTENSION. CEREBRAL HYPERPERFUSION SYNDROME (CHS) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CAROTID STENTS. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE EVENT REPORTED DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY SORIMACHI ET AL OBSTRUCTION OF PORES IN DISTAL PROTECTION FILTERS AND ANGIOGRAPHICALLY-DOCUMENTED FLOW IMPAIRMENT DURING CAROTID ARTERY STENTING, J ENDOVASC THERAPY 17 (2010) 661-670; A PATIENT WITH NORMAL FLOW DEVELOPED HYPERPERFUSION SYNDROME WITH A MINOR VISUAL FIELD DEFECT 2 DAYS AFTER THE PROCEDURE. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO DETERMINE ANY RELATIONSHIP BETWEEN ANGIOGRAPHICALLY DOCUMENTED FLOW IMPAIRMENT ASSOCIATED WITH THE ANGIOGUARD XP CEREBRAL PROTECTION FILTER DURING CAROTID ARTERY STENTING (CAS) AND THE CONDITION OF THE PORES IN THE RETRIEVED FILTER. ANGIOGUARD XP FILTERS WERE RETRIEVED FROM 54 CONSECUTIVE PATIENTS (50 MEN; MEAN AGE WAS 71 YEARS, RANGE 53-83) WHO UNDERWENT 56 FILTER-PROTECTED CAS PROCEDURES (2 BILATERAL) UNDER AN APPROVED TREATMENT PROTOCOL. CAS WAS OFFERED TO PATIENTS WITH AN ASYMPTOMATIC CAROTID ARTERY STENOSIS GREATER THAN OR EQUAL TO 80% OR A SYMPTOMATIC CAROTID ARTERY STENOSIS GREATER THAN OR EQUAL TO 50% PATIENTS WITH A HISTORY OF A DISABLING STROKE WERE NOT ELIGIBLE FOR CAS. IN THIS COHORT, 39 LESIONS WERE SYMPTOMATIC AND 17 LESIONS WERE ASYMPTOMATIC. THE CAROTID ARTERY STENOSIS, WHICH AVERAGED 76.1% (RANGE 50%-99%), WAS LOCATED ON THE RIGHT IN 27 CASES AND ON THE LEFT IN 29. ANTIPLATELET THERAPY CONSISTING OF ASPIRIN (100MG/D) AND CLOPIDOGREL (75MG/D) OR CILOSTAZOL (200 MG/D) WAS STARTED AT LEAST 5 DAYS BEFORE THE PROCEDURE. ANGIOGRAPHY WAS PERFORMED USING HAND-INJECTED IOXAGLIC ACID AS THE CONTRAST MEDIUM. DSA IMAGES (3 FRAMES/S) WERE OBTAINED ON THE AXION ARTIS SYSTEM. PERCUTANEOUS ACCESS WAS GAINED THROUGH THE FEMORAL ARTERY. HEPARIN WAS GIVEN IV TO MAINTAIN AN ACTIVATED CLOTTING TIME (ACT) >2 TIMES BASELINE, WITH A TARGET OF AT LEAST 300 SECONDS. STENOSES WERE CROSSED WITH 5-,6-, OR 7-MM-DIAMETER ANGIOGUARD XP FILTERS SELECTED TO BE 0.5 TO 1.5MM LARGER THAN THE DISTAL VESSEL DIAMETER AS MEASURED ON DSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384221 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| S