BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2000672 · Received February 24, 2011

    Report

    Report Number
    9616099-2011-00130
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 2, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2011-00019, 9616099-2011-00128, AND 9616099-2011-00130. UPON FURTHER REVIEW, SINCE THE THROMBUS WAS PRESENT PRIOR TO STENT DEPLOYMENT AND IT WAS UNKNOWN IF THERE WAS THROMBUS PRESENT INSIDE THE STENT AFTER DEPLOYMENT, THE CODE THROMBUS WAS REMOVED FROM (B)(4) (MDR REPORT 9616099-2011-00130). SINCE THE TRANSIENT ISCHEMIC ATTACK (TIA) FULLY RESOLVED WITH NO NEUROLOGICAL DEFICIT, THE TIA WAS DETERMINED TO BE NON-REPORTABLE. THE THROMBOSIS AND TIA WILL BE UNREPORTED AS THEY WILL NO LONGER BE DEEMED MDR REPORTABLE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2011-00019, 9616099-2011-00128, AND 9616099-2011-00130. THE LEFT HEMISPHERIC TIA OCCURRED AT THE TIME OF THE ANGIOGUARD RX PLACEMENT IN THE DISTAL LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION IN THE LEFT ICA WAS VERY TIGHT AND THE PHYSICIAN FELT THAT CROSSING THE LESION WITH THE ANGIOGUARD RX WAS THE SOURCE OF THE EMBOLUS. NO INTRA-ARTERIAL TPA WAS USED, AND THE FILTER HAD NO DEBRIS OR THROMBUS AFTER RETRIEVAL. THE PATIENT FULLY RECOVERED WITH RIGHT ARM WEAKNESS IN TWO HOURS. THERE WERE NO RESIDUAL NEUROLOGICAL DEFICITS AND THE PATIENT HAD NO NEUROLOGICAL SEQUELAE DEFICITS. THE PATIENT IS CURRENTLY DOING WELL WITH NO NEUROLOGICAL DEFICITS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION :(RECEIVED ON (B)(4) 2012) THE CHANGE IN REPORTABILITY ON A PREVIOUSLY TIA EVENT CODED IS TO REFLECT THE ADJUDICATION MINUTES RECEIVED AGREES WITH THE ASSESSMENT OF CVA-MINOR, IPSILATERAL, ISCHEMIC/EMBOLIC, AND RELATED TO THE DEVICE AND THE PROCEDURE. THIS EVENT WAS PREVIOUSLY CAPTURED AS A TIA THAT FULLY RESOLVED WITHIN TWENTY FOUR HOURS. THE EVENT WAS CAPTURED AS A COMPLAINT, NOT REPORTABLE. THE NEW INFORMATION WILL BE CAPTURED AS AN ISCHEMIC STROKE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE SAPPHIRE STUDY, A (B)(6) MALE WITH A HISTORY OF LEFT-SIDED CAROTID ENDARTERECTOMY (CEA), SEVERE PULMONARY DISEASE, HYPERLIPIDEMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, SMOKING, CORONARY ARTERY DISEASE, CORONARY REVASCULARIZATION, HYPERTENSION, RECURRENT STENOSIS, AND RESTENOSIS AT SITE OF PREVIOUS CEA) EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) POST STENT DEPLOYMENT. THE TARGET LESION WAS LOCATED IN THE BIFURCATION OF THE LEFT COMMON CAROTID ARTERY. THE LESION WAS PREVIOUSLY REVASCULARIZED VIA CAROTID ENDARTERECTOMY. THE LESION WAS DESCRIBED AS 90% STENOSED, THROMBOSED, 40MMM IN LENGTH, ARCH TYPE II, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER AND NON-TORTUOUS. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. PRE-DILATION WAS NOT PERFORMED. A 5MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. A 6X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED FOLLOWED BY A 6X20MM PRECISE PRO RX STENT OVERLAPPING THE FIRST STENT. IT WAS UNKNOWN IF THE LESION WAS POST-DILATED. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. FOLLOWING STENT DEPLOYMENT, THE PATIENT EXPERIENCED APHASIA AND RIGHT-SIDED HEMIPARESIS AND WAS DIAGNOSED WITH A TIA. THERE WAS NO VISUAL FIELD LOSS, HEMINEGLECT, OR HEMITAXIA. THE EVENT LASTED APPROXIMATELY TWO HOURS. THE PATIENT IS CURRENTLY DOING WELL WITH NO NEUROLOGICAL DEFICITS. THROMBUS WAS PRESENT IN THE LESION BEFORE STENTING, AND AFTER THE FIRST PRECISE PRO RX STENT WAS APPROPRIATELY TRAPPED AGAINST THE WALL OF THE ARTERY. THE LEFT HEMISPHERIC TIA OCCURRED AT THE TIME OF THE ANGIOGUARD RX PLACEMENT IN THE DISTAL LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION IN THE LEFT ICA WAS VERY TIGHT AND THE PHYSICIAN FELT THAT CROSSING THE LESION WITH THE ANGIOGUARD RX WAS THE SOURCE OF THE EMBOLUS. NO INTRA-ARTERIAL TPA WAS USED, AND THE FILTER HAD NO DEBRIS OR THROMBUS AFTER RETRIEVAL. THE PATIENT FULLY RECOVERED WITH RESIDUAL MILD HAND NUMBNESS. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IS NOT AVAILABLE FOR ANALYSIS. HOWEVER, 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. CEREBROVASCULAR ACCIDENT IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. IT CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH. 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. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00130, 9616099-2011-00128 AND 1016427-2011-00019.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) POST STENT DEPLOYMENT. THE TARGET LESION WAS LOCATED IN THE BIFURCATION OF THE LEFT COMMON CAROTID ARTERY. THE LESION WAS PREVIOUSLY REVASCULARIZED VIA CAROTID ENDARTERECTOMY. THE LESION WAS DESCRIBED AS 90% STENOSED, THROMBOSED, 40MMM IN LENGTH, ARCH TYPE II, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER AND NON-TORTUOUS. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. PRE-DILATION WAS NOT PERFORMED. A 5MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. A 6X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. AN ADDITIONAL 6X20MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED OVERLAPPING THE FIRST STENT. IT WAS UNKNOWN IF THE LESION WAS POST-DILATED. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. FOLLOWING STENT DEPLOYMENT, THE PATIENT EXPERIENCED APHASIA AND RIGHT-SIDED HEMIPARESIS AND WAS DIAGNOSED WITH A TIA. THERE WAS NO VISUAL FIELD LOSS, HEMINEGLECT, OR HEMIATAXIA. THE EVENT LASTED LESS THAN TWENTY-FOUR HOURS AND THE PATIENT FULLY RECOVERED. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. THE EVENT WAS RELATED TO THE INDEX PROCEDURE. THE PATIENT DID NOT HAVE ANY KNOWN ALLERGIES TO NITINOL, NICKEL, OR TITANIUM. A 6FR SHEATH WAS USED. ALL CONNECTIONS WERE TIGHT AND WELL SEALED DURING ASPIRATION, AND THERE WAS NO EVIDENCE OF AIR EMBOLI. ASPIRATION WAS PERFORMED PRIOR TO ALL CONTRAST INJECTIONS, AND NO AIR OR CLOTS WERE NOTED. THROMBUS WAS PRESENT IN THE LESION BEFORE STENTING, AND AFTER THE FIRST PRECISE PRO RX STENT WAS APPROPRIATELY TRAPPED AGAINST THE WALL OF THE ARTERY. THERE WAS NO THROMBUS OF THE STENT AND NO THROMBUS IN THE LESION WITH THE SECOND STENT PLACEMENT. THE PATIENT HAD A LEFT HEMISPHERIC TIA WITH RESULTANT RIGHT HEMIPARESIS WHICH WAS TRANSIENT.

    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 NA 15112462

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O 5MM ANGIOGUARD RX