BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3145673 · Received June 4, 2013

    Report

    Report Number
    9616099-2013-00344
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    November 19, 2012
    Report Date
    January 4, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 6 MM ANGIOGUARD, 142 CM. AVIATOR PLUS 5 MM. X 2 CM. PTA BALLOON CATHETER. ADDENDUM: ADDITIONAL INFORMATION/ADJUDICATION MINUTES RECEIVED INDICATED THE COMMITTEE AGREED WITH THE ADVERSE EVENT (AE) AS CAPTURED-PROCEDURE/DEVICE RELATED. FOLLOWING POST-DILATION AND REMOVAL OF THE ANGIOGUARD, THE PATIENT COMPLAINED OF RIGHT ARM NUMBNESS/RIGHT FACIAL TIGHTNESS. THE SYMPTOMS WERE TREATED BY ADMINISTRATION OF NITROGLYCERIN (NTG) FOR VASODILATION. THERE WAS NO REPORT OF VASOSPASM. THE ANGIOGUARD WAS IN PLACE AT THE TIME OF THE EVENT. NO VASOSPASM WAS NOTED. THE BALLOON CATHETER USED FOR POST-DILATION OF THE PRECISE STENT WAS A 142 CM. AVIATOR PLUS 5 MM. X 2 CM. PTA BALLOON CATHETER. DURING THE STUDY INDEX PROCEDURE, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK/TIA. THE EVENT OCCURRED DURING POST-DILATION USING AN AVIATOR PLUS 5 MM. X 2 CM. BALLOON CATHETER. THE ONSET OF THE EVENT WAS SUDDEN. THE PATIENT¿S RECOVERY WAS FULL WITH NO DEFICIT. THE DURATION OF THE EVENT WAS LESS THAN TWENTY-FOUR HOURS AND WAS NOT RELATED TO A CORDIS PRODUCT/WAS RELATED TO THE PROCEDURE. THE PATIENT WAS DISCHARGED THE DAY OF THE PROCEDURE. THE PATIENT WAS ASYMPTOMATIC FOR THE PROCEDURE. THE TARGET LESION WAS THE OSTIAL LEFT INTERNAL CAROTID ARTERY/LICA. A 6 MM. ANGIOGUARD WAS USED FOR THE PROCEDURE. DEBRIS WAS NOTED TO BE IN THE DISTAL EMBOLIC PROTECTION DEVICE AFTER REMOVAL. A PRECISE 8 X 30 STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE EVENT WAS ORIGINALLY CAPTURED AS A NOT REPORTABLE COMPLAINT. ADDITIONAL INFORMATION/ADJUDICATION MINUTES RECEIVED INDICATED THE COMMITTEE AGREED WITH THE ADVERSE EVENT (AE) AS CAPTURED-PROCEDURE/DEVICE RELATED. FOLLOWING POST-DILATION AND REMOVAL OF THE ANGIOGUARD, THE PATIENT COMPLAINED OF RIGHT ARM NUMBNESS/RIGHT FACIAL TIGHTNESS. THE SYMPTOMS WERE TREATED BY ADMINISTRATION OF NITROGLYCERIN (NTG) FOR VASODILATION. THERE WAS NO REPORT OF VASOSPASM. THE ANGIOGUARD WAS IN PLACE AT THE TIME OF THE EVENT. NO VASOSPASM WAS NOTED. THE BALLOON CATHETER USED FOR POST-DILATION OF THE PRECISE STENT WAS A 142 CM. AVIATOR PLUS 5 MM. X 2 CM. PTA BALLOON CATHETER. THE PRODUCTS WERE NOT AVAILABLE FOR INSPECTION. (B)(4): 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 15595288 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. TIA IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU AS SUCH. TIA IS OFTEN ASSOCIATED WITH A TEMPORARY STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY COLLECT IN THE EMBOLIC PROTECTION DEVICE OR FLOW DOWNSTREAM POTENTIALLY DISRUPTING PERFUSION BOTH DURING AND AFTER CAROTID STENT IMPLANTATION. BY DEFINITION (MAYOCLINIC.ORG), THE SYMPTOMS OF A TIA MAY LAST UP TO 24 HOURS, BUT THEY OFTEN LAST ONLY A FEW MINUTES. TIA OCCURS WHEN THE BLOOD SUPPLY TO PART OF THE BRAIN IS BRIEFLY INTERRUPTED. TIA SYMPTOMS ARE SIMILAR TO THOSE OF STROKE BUT DO NOT LAST AS LONG. MOST SYMPTOMS OF A TIA DISAPPEAR WITHIN AN HOUR. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2013-00344, # 1016427-2013-00093 AND # 9616099-2013-00493.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDENDUM: ADDITIONAL INFORMATION INDICATED THAT THE ANGIOGUARD WAS IN PLACE AT THE TIME OF THE EVENT. NO VASOSPASM WAS NOTED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2013-00344 AND # 1016427-2013-00093.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM (B)(6) INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND THAT DURING THE STUDY INDEX PROCEDURE, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK/TIA. THE EVENT OCCURRED DURING POST-DILATION. THE ONSET OF THE EVENT WAS SUDDEN. THE PATIENT¿S RECOVERY WAS FULL WITH NO DEFICIT. THE DURATION OF THE EVENT WAS LESS THAN TWENTY-FOUR HOURS AND WAS NOT RELATED TO A CORDIS PRODUCT/WAS RELATED TO THE PROCEDURE. THE PATIENT WAS DISCHARGED THE DAY OF THE PROCEDURE. THE PATIENT WAS ASYMPTOMATIC FOR THE PROCEDURE. THE TARGET LESION WAS THE OSTIAL LEFT INTERNAL CAROTID ARTERY/LICA. A 6 MM. ANGIOGUARD WAS USED FOR THE PROCEDURE. A PRECISE 8 X 30 STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL STENOSIS WAS 0%. THE PROXIMAL LICA TARGET LESION WAS REPORTED TO BE: AN 80% STENOSIS, 22 MM. IN LENGTH, ABSENT OF THROMBUS, 6 MM. REFERENCE DIAMETER, AND ECCENTRIC. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. ADDENDUM: ADDITIONAL INFORMATION/ADJUDICATION MINUTES RECEIVED INDICATED THE COMMITTEE AGREED WITH THE ADVERSE EVENT (AE) AS CAPTURED-PROCEDURE/DEVICE RELATED. FOLLOWING POST-DILATION AND REMOVAL OF THE ANGIOGUARD, THE PATIENT COMPLAINED OF RIGHT ARM NUMBNESS/RIGHT FACIAL TIGHTNESS. THE SYMPTOMS WERE TREATED BY ADMINISTRATION OF NITROGLYCERIN (NTG) FOR VASODILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247206 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15595288

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 6 MM ANGIOGUARD