BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1850342 · Received October 1, 2010

    Report

    Report Number
    9616099-2010-00734
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2010-00734 & 1016427-2010-00115 THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2010-00734 AND 1016427-2010-00115. INFORMATION RECEIVED VIA THE (B)(4) STUDY INDICATED THAT THE PATIENT EXPERIENCED A MYOCARDIAL ISCHEMIC EVENT/MYOCARDIAL INFARCTION (MI) THE SAME DAY AS TREATMENT OF A RIGHT INTERNAL CAROTID (ICA) USING THE ANGIOGUARD EMBOLIC PROTECTION DEVICE AND IMPLANTATION OF A PRECISE STENT. IT WAS INDICATED AS A NON-Q WAVE MI. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT BEGAN COMPLAINING OF CHEST PAIN AT THE END OF THE INDEX PROCEDURE. HIS PAIN WAS MILD INITIALLY BUT WORSENED AFTER THE ANGIOGUARD WAS REMOVED AND CONTINUED UNTIL HE WAS MOVED TO THE ICU. HIS PAIN COMPLETELY RESOLVED AFTER NTG AND MORPHINE WERE GIVEN. HE DIDN'T REQUIRE ANY FURTHER PAIN MEDS OR NTG. HE WAS WEANED FROM HIS DOPAMINE THAT HAD BEEN STARTED DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT THE EXACT TIME OF THE MI IS IMPOSSIBLE TO DETERMINE SINCE HE DIDN'T HAVE ABNORMAL TROPONINS UNTIL THE 8 HOUR LAB WAS DRAWN. HE RECOVERED UNEVENTFULLY AND DID NOT REQUIRE ANY FURTHER TREATMENTS OR PROCEDURES. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, ABNORMAL STRESS TEST, CABG, HISTORY OF SMOKING, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION. ADDITIONAL HIGH RISK CRITERIA WAS INDICATED AS UNSTABLE ANGINA (CCS CLASS III/IV), ABNORMAL STRESS TEST AND KNOWLEDGE OF TWO OR MORE PROXIMAL OR MAJOR DISEASED CORONARY ARTERIES WITH >70% STENOSIS THAT HAD NOT OR COULD NOT BE REVASCULARIZED. BASELINE NIH STROKE SCORE AND RANKIN STROKE SCARE WERE 0. THE PATIENT WAS ASYMPTOMATIC. THE OSTIAL RICA LESION WAS 80% STENOSED WITH A REFERENCE VESSEL DIAMETER OF 5.0MM. THERE WAS MILD LESION CALCIFICATION AND TORTUOSITY. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. A 5MM ANGIOGUARD RX BASKET WAS SUCCESSFULLY DELIVERED WITHOUT TECHNICAL PROBLEMS OR ASSOCIATED ADVERSE EVENT. THE LESION WAS PRE-DILATED WITH NO RESISTANCE DOCUMENTED. THE 8X40 PRECISE RX WAS DELIVERED TO THE TARGET LESION AND THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED WITHOUT TECHNICAL PROBLEMS. THE FINAL TARGET LESION STENOSIS WAS 0%. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE WITH STROKE SCORES UNCHANGED FROM BASELINE. ANTIPLATELET THERAPY INCLUDED PRE, INTRA, AND POST PROCEDURE CLOPIDOGREL AND PRE AND POST PROCEDURE AND DISCHARGE ASPIRIN. (B)(4): THE ANGIOGUARD IS NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01414309 WHICH CORRESPONDS TO CORDIS LOT 71109512. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. (B)(4): THE PRECISE STENT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 15016511 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH INTERVENTIONAL PROCEDURES INCLUDING CAROTID STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THIS PATIENT'S SIGNIFICANT CARDIOVASCULAR DISEASE INCLUDING UNSTABLE ANGINA AND UNTREATED KNOWN CORONARY ARTERY STENOSES PUT HIM AT A GREATER RISK FOR MYOCARDIAL INFARCTION. THE PHYSIOLOGICAL STRESS OF THE INTERVENTIONAL PROCEDURE CAN PLACE THE PATIENT AT RISK FOR ISCHEMIC EVENTS. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT AND PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION ANY DEVICE MANUFACTURING RELATED ISSUES OR TO ANY DEVICE PERFORMANCE ISSUES IMPACTING THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE (B)(6) MALE PATIENT RECEIVED A PRECISE STENT IN THE RIGHT INTERNAL CAROTID ARTERY. THE NOTIFICATION RECEIVED FOR THE (B)(4) STUDY INDICATED THAT THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION THE SAME DAY AS THE INDEX PROCEDURE. ADDENDUM (09/21/2010): THE PATIENT BEGAN HAVING CHEST PAIN AT THE END OF THE INDEX PROCEDURE. HIS PAIN WAS MILD INITIALLY BUT WORSENED AFTER THE ANGIOGUARD WAS REMOVED AND CONTINUED UNTIL HE WAS MOVED TO THE ICU. HIS PAIN COMPLETELY RESOLVED AFTER NTG AND MORPHINE WERE GIVEN. HE DIDN'T REQUIRE ANY FURTHER PAIN MEDS OR NTG. PATIENT WAS WEANED FROM HIS DOPAMINE THAT HAD BEEN STARTED DURING THE INDEX PROCEDURE. THE EXACT TIME OF THE MI IS IMPOSSIBLE TO DETERMINE SINCE PATIENT DIDN'T HAVE ABNORMAL TROPONINS UNTIL THE 8 HOUR LAB WAS DRAWN. HE RECOVERED UNEVENTFULLY AND DID NOT REQUIRE ANY FURTHER TREATMENTS OR PROCEDURES.

    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 15016511

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ANGIOGUARD DEVICE