BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3354872 · Received September 18, 2013

    Report

    Report Number
    9616099-2013-00591
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    August 24, 2013
    Report Date
    August 26, 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/ADJUDICATION MINUTES WERE RECEIVED AND REVIEWED. THE COMMITTEE INDICATED: NON-Q WAVE MI THE DAY AFTER THE INDEX PROCEDURE AS PROCEDURE-RELATED/AGREE. AS SUCH, THERE IS NO CHANGE TO THE ADVERSE EVENT OR CODING OF THE FILE AND NO CHANGE TO THE COMPLAINT CONCLUSION. ADDITIONAL INFORMATION INCLUDED IN THE ADJUDICATION MINUTES: THE PATIENT IS A (B)(6) MAN WITH A HISTORY OF CONTRALATERAL CAROTID ARTERY OCCLUSION, CAD, ANGINA, CABG SURGERY IN 1995 AND 2003, PTCA IN 2003, CHF, ABNORMAL STRESS TEST, DYSLIPIDEMIA, HYPERTENSION AND RENAL INSUFFICIENCY. THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DELIVERY OF THE ANGIOGUARD¿ RX ECGW, PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF ONE PRECISE® PRO RX STENT IN THE LEFT PROXIMAL ICA. THE SITE REPORTED A 10% FINAL RESIDUAL STENOSIS. PRE-PROCEDURE THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN SCORE WAS 0. POST-PROCEDURE THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN SCORE WAS 0. THE SITE REPORTED A NON-Q WAVE MI EVENT THE DAY AFTER THE PROCEDURE. THE PATIENT HAD AN INCREASED BLOOD PRESSURE AND 4 EPISODES OF CHEST PAIN WITH 1 EPISODE GOING DOWN THE RIGHT ARM. THE PATIENT REQUESTED NITROGLYCERIN AS HE USES FOR ANGINA AT HOME. EACH EPISODE WAS TREATED WITH A NITROGLYCERIN TABLET; SYMPTOMS RESOLVED WITH EACH NITROGLYCERIN. THE CHEST PAIN REPORTEDLY BEGAN AFTER BREAKFAST. HE WAS PLACED ON HEPARIN AND NITROGLYCERIN DRIPS. A BETA BLOCKER WAS TITRATED. ON (B)(6) 2013 AT 05:30 THE CK WAS 27 (NL 170, RATIO <1) WITH A CKMB OF 1 (NL 6.6, RATIO <1). NO FURTHER CK OR CKMB LABS WERE DRAWN. ON (B)(6) 2013 AT 11:57 THE TROPONIN I WAS 0.04 (NL 0.03, RATIO 1.3). ON (B)(6) 2013 AT 17:52 THE TROPONIN I WAS 0.08 (RATIO 2.66). ON (B)(6) 2013 AT 23:47 THE TROPONIN I WAS 0.25 (RATIO 8.33). ON (B)(6) 2013 AT 12:02 THE TROPONIN I WAS 0.25 (RATIO 8.33). ON (B)(6) 2013 AT 07:15 THE TROPONIN I WAS 0.36 (RATIO 12). ON (B)(6) 2013 AT 15:03 THE TROPONIN I WAS 0.29 (RATIO 9.66). ON (B)(6) 2013 AT 22:55 THE TROPONIN I PEAKED AT 0.39 (RATIO 13). ON (B)(6) 2013 AT 06:20 THE TROPONIN I WAS 0.34 (RATIO 11.33). ECGS SHOWED A SITE-REPORTED RIGHT BUNDLE BRANCH BLOCK PRE-PROCEDURE AND POST-PROCEDURE. THE BASELINE ECG, AND ECGS FROM THE DAY AFTER THE PROCEDURE AND THE NEXT DAY ARE AVAILABLE FOR VIEWING. A CORONARY ANGIOGRAM WAS DISCUSSED FOR A POSSIBLE PCI, BUT THE PATIENT WAS RELUCTANT TO UNDERGO DUE TO HIS RENAL INSUFFICIENCY AND CONCERN FOR WORSENING RENAL FUNCTION. HIS RENAL FUNCTION REPORTEDLY IMPROVED DURING THE HOSPITALIZATION. THE PATIENT DECIDED ON MEDICAL THERAPY AND IF ANGINA SYMPTOMS CONTINUED, AN ANGIOGRAM WOULD BE PLANNED USING CONTRAST-LIMITING TECHNIQUES. THE PATIENT WAS DISCHARGED FOUR DAYS AFTER THE PROCEDURE ON ASA AND CLOPIDOGREL. ON THE 30-DAY FOLLOW-UP VISIT WAS COMPLETED. THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN SCORE WAS 0. THE PATIENT WAS TAKING ASA AND CLOPIDOGREL. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE DAY AFTER THE STUDY INDEX PROCEDURE FOR CAROTID STENT IMPLANTATION, THE PATIENT EXPERIENCED A NON-Q WAVE MYOCARDIAL INFARCTION (MI). THE EVENT WAS NOT RELATED TO THE STUDY INDEX OR A CORDIS PRODUCT. NO CORONARY ANGIOGRAPHY WAS PERFORMED. ECG¿S WERE ASSOCIATED. NO NEW ST ELEVATION WAS DOCUMENTED. NO CK¿S WERE ASSOCIATED. THE PATIENT WAS DISCHARGED FOUR DAYS AFTER THE PROCEDURE. THE TARGET LESION FOR THE INDEX PROCEDURE WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (LICA). THE LESION WAS REPORTED TO BE: A 90% STENOSIS, 18 MM. IN LENGTH, ABSENT OF THROMBUS, 5.8 MM. REFERENCE DIAMETER, MODERATELY CALCIFIED, NOT TORTUOUS, AND ECCENTRIC. THE LESION WAS PRE-DILATED. A PRECISE 10 X 40 STENT WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION. A 7 MM. ANGIOGUARD WAS USED. THE RESIDUAL STENOSIS WAS 10%. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, OR DEVICE DEVIATIONS REPORTED DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. 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 15825378 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE INFORMATION PROVIDED AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MYOCARDIAL INFARCTION IS A KNOWN ADVERSE EVENT THAT MAY OCCUR DURING INVASIVE PROCEDURES. THERE IS NO INFORMATION AVAILABLE THAT WOULD RELATE THIS EVENT TO CAROTID STENT IMPLANTATION. THERE ARE PATIENT FACTORS: PREVIOUS/RECENT MI, PREVIOUS PCI, HYPERTENSION, AND KNOWN SEVERE LEFT VENTRICULAR DYSFUNCTION LVEF<35%; AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. WITHOUT THE RETURN OF THE ACTUAL COMPLAINT PRODUCT THE EVENT REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED, NOR CAN ANY CONCLUSION REGARDING A ROOT CAUSE BE DRAWN. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    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 15825378 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(6) STUDY INDICATED THE DAY AFTER THE STUDY INDEX PROCEDURE FOR CAROTID STENT IMPLANTATION, THE PATIENT EXPERIENCED A NON-Q WAVE MYOCARDIAL INFARCTION (MI). THE EVENT WAS NOT RELATED TO THE STUDY INDEX OR A CORDIS PRODUCT. NO CORONARY ANGIOGRAPHY WAS PERFORMED. ECG¿S WERE ASSOCIATED. NO NEW ST ELEVATION WAS DOCUMENTED. NO CK¿S WERE ASSOCIATED. THE PATIENT WAS DISCHARGED FOUR DAYS AFTER THE PROCEDURE. THE TARGET LESION FOR THE INDEX PROCEDURE WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (LICA). THE LESION WAS REPORTED TO BE: A 90% STENOSIS, 18 MM. IN LENGTH, ABSENT OF THROMBUS, 5.8 MM. REFERENCE DIAMETER, MODERATELY CALCIFIED, NOT TORTUOUS, AND ECCENTRIC. THE LESION WAS PRE-DILATED. A PRECISE 10 X 40 STENT WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION. A 7 MM. ANGIOGUARD WAS USED. THE RESIDUAL STENOSIS WAS 10%. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, OR DEVICE DEVIATIONS REPORTED DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470082 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15825378

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L 7 MM ANGIOGUARD