BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1871427 · Received October 15, 2010

    Report

    Report Number
    9616099-2010-00800
    Event Type
    Death
    Date Received
    October 15, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 20, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT PRESENTED WITH SUDDEN ONSET OF LEFT-SIDED HEMIPLEGIA AND WAS FOUND DOWN IN THE FIELD. TWO SUBSEQUENTLY BROUGHT TO MALE EMERGENCY DEPARTMENT FOR FURTHER EVALUATION. UPON ARRIVAL, SHE WAS EVALUATED BY THE EMERGENCY ROOM STAFF UROLOGY SERVICES UNDERWENT CT ANGIOGRAM WITH PERFUSION WHICH DEMONSTRATED ACUTE CLOT IN THE RIGHT MI SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PATIENT WAS DIAGNOSED WITH AN ACUTE ISCHEMIC STROKE WITH (B)(6) STROKE SCALE OF 22. GIVEN THE SEVERITY OF THE STROKE, CONSENT WAS OBTAINED FROM THE PATIENT'S DAUGHTER FOR EMERGENCY MECHANICAL THROMBECTOMY. SHE WAS NOT CONSIDERED> CANDIDATE FOR (LV) INTRAVENOUS TPA GIVEN THE EXACT TIME OTHER ONSET WAS UNKNOWN. A 5FRENCH INTRODUCER SHEATH WAS PLACED INTO THE RIGHT COMMON FEMORAL ARTERY. THEN A 5 FRENCH DAV CATHETER WAS INTRODUCED INTO THE SYSTEM OVER A 35 GLIDEWIRE AND NAVIGATED THROUGH THE NORMAL VASCULAR CHANNELS AND ADVANCED SELECTIVELY INTO THE FOLLOWING VESSELS: RIGHT COMMON CAROTID ARTERY. CERVICAL AND INTRACRANIAL VIEWS WERE OBTAINED. AT THIS POINT, THE FILMS WERE CAREFULLY REVIEWED, SHOWING COMPLETE OCCLUSION THE RIGHT (MCA) MIDDLE CEREBRAL ARTERY DISTAL TO THE M-1 SEGMENT. AT THIS POINT, 2000 UNITS INTRAVENOUS HEPARIN WAS GIVEN. A TAD-II EXCHANGE WIRE WAS ADVANCED AND THE DAV CATHETER WAS REMOVED. AN 8 FRENCH CONCENTRIC BALLOON GUIDE CATHETER WAS ADVANCED INTO THE SYSTEM AND PARKED INTO THE DISTAL SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. AN 18 L MICROCATHETER WAS NAVIGATED OVER SYNCHRO 14 MICROWIRE, AND THIS WAS USED TO GO ACROSS THE CLOT ON THE DISTAL RIGHT INTERNAL CAROTID ARTERY INTO THE DISTAL RIGHT MIDDLE CEREBRAL ARTERY. THE WIRE WAS THEN REMOVED AND MICRO INJECTION DEMONSTRATED THE PRESENCE OF THE MICROCATHETER INTO THE LUMEN OF THE DISTAL MIDDLE CEREBRAL ARTERY WITH NO EVIDENCE OF ANY CONTRAST EXTRAVASATION. A V2.5 MERCL CLOT RETRIEVER WAS ADVANCED INTO THE SYSTEM AND DEPLOYED INTO THE CLOT ON THE RIGHT MIDDLE CEREBRAL ARTERY. WITH INFLATION OF THE BALLOON ON THE TIP OF THE GUIDE CATHETER AND UNDER-ASPIRATION AND FLOW ARREST, THE V2.5 RETRIEVER AND MICROCATHETER SYSTEM WERE SLOWLY PULLED BACK WITH OPENING OF THE MI SEGMENT. THE SYSTEM WAS REMOVED AND AGAIN RE-ADVANCED INTO THE M2 BRANCH OVER THE MICROWIRE. TWO ADDITIONAL ATTEMPTS WERE MADE TO ATTEMPT TO RETRIEVE CLOT USING A DAC CATHETER TO PROVIDE ADDITIONAL STABILITY. THERE WAS PERSISTENT CLOT BURDEN IN THE M2 SEGMENT. THE DAC CATHETER WAS REMOVED AND A PROWLER SELECT PLUS MICROCATHETER WAS ADVANCED INTO THE SUPERIOR M2 BRANCH. A 4.5X22 MM ENTERPRISE STENT WAS DEPLOYED ACROSS THE CLOTS. ANGIOGRAMS OF PERFORMED FOLLOWING STENT DEPLOYMENT DEMONSTRATE RECONSTITUTION OF FLOW INTO THAT DIVISION. ANTERIOR DIVISION AND A PERSISTENT CLOT BURDEN, THIS WAS CROSSED USING THE MICROCATHETER. WE THEN INSTILLED 6 MG OF REOPRO THROMBOLYSIS IN TO THE CLOT. IV REOPRO WAS ALSO GIVEN. THE MICROCATHETER WAS REMOVED OVER AN EXCHANGE LENGTH TRANSCEND WIRE. GUIDE CATHETER WAS DRAWN PROXIMALLY. CERVICAL CAROTID ANGIOGRAMS WERE PERFORMED. A 5 X 30 PRECISE RX STENT WAS THEN DEPLOYED ACROSS THE CERVICAL CAROTID DISSECTION. FINAL AP LATERAL CERVICAL CEREBRAL ANGIOGRAMS WERE PERFORMED. GUIDING CATHETER WAS THEN REMOVED. FEMORAL SHEATH WAS SECURED USING SILK SUTURE. THE PATIENT WAS TAKEN TO THE CT SCANNER FOR ADDITIONAL POST PROCEDURAL IMAGING. THE PATIENT WAS THEN TAKEN TO THE (ICU) INTENSIVE CARE UNIT FOR ADDITIONAL CARE. INTERPRETATION OF THE FILMS: RIGHT COMMON CAROTID ARTERY: (AP) ANTERIOR-POSTERIOR, LATERAL AND OBLIQUE VIEWS. CERVICAL INJECTIONS. INJECTION INTO THE RIGHT COMMON CAROTID ARTERY DEMONSTRATES NO EVIDENCE OF CAROTID STENOSIS OR DISSECTION. LNTRACRANIAL VIEWS: AP, LATERAL AND AP LATERAL AND OBLIQUE ANGIOGRAMS PERFORMED FROM THE RIGHT INTERNAL CAROTID ARTERY DEMONSTRATES OCCLUSION OF THE MI SEGMENT. THERE IS NO FLOW DISTAL TO THIS. THERE IS EVIDENCE OF (ACA) ANTERIOR COMMUNICATING ARTERY/(MCA) MIDDLE CEREBRAL ARTERY COLLATERALIZATION PIAL COLLATERALIZATION. THERE IS FLOW POSSIBLE SMALL POSTER COMMUNICATING ARTERY TO THE TOP OF THE BASILAR SYSTEM. THERE IS EVIDENCE OF SOME FLOW DEFICIT IN THE DISTAL PERICALLOSAL ARTERY CONSISTENT WITH EMBOLUS. RIGHT INTERNAL CAROTID ARTERY: AP LATERAL AND OBLIQUE ANGIOGRAMS PERFORMED FROM THE RIGHT INTERNAL CAROTID ARTERY COMPLETED FOLLOWING THE FIRST PASS OF THE BURSA CLOT RETRIEVER DEMONSTRATE OPENING OF THE MI BRANCH WITH CLOT NOW RESTING IN THE M2 BRANCHES. RIGHT INTERNAL CAROTID ARTERY: OBLIQUE ANGIOGRAMS PERFORMED FROM THE RIGHT INTERNAL CAROTID ARTERY FOLLOWING COMPLETION OF PASSING OF MERCI Y FOR THE SECOND RETRIEVAL DEMONSTRATES SOME RECONSTITUTION OF THE SUPERIOR BRANCH OF THE MCA. OBLIQUE AND LATERAL CEREBRAL ANGIOGRAMS PERFORMED FROM THE RIGHT INTERNAL CAROTID ARTERY DEMONSTRATE RECONSTITUTION INTO THE DISTAL PORTION OF THE MCA CIRCULATION FOLLOWING THE THIRD PASS OF THE CLOT RETRIEVER. AP LATERAL AND ANGIOGRAMS PERFORMED FROM THE RIGHT INTERNAL CAROTID ARTERY DEMONSTRATE PLACEMENT OF THE MICROWIRE ACROSS THE INFERIOR BRANCH OF THE M2 DIVISION FOR STENT PLACEMENT. AP AND LATERAL CEREBRAL ANGIOGRAMS PERFORMED FOLLOWING DEPLOYMENT OF ENTERPRISE STENTS DEMONSTRATE FLOW RESTORATION TO THE M3 BRANCHES DISTAL TO THE STENT. THERE IS CONTINUED FLOW RESTRICTION IN THE SUPERIOR DIVISION. AP AND LATERAL CEREBRAL ANGIOGRAMS PERFORMED FROM THE RIGHT INTERNAL CAROTID ARTERY FOLLOWING INFUSION OF REOPRO THROMBOLYSIS DEMONSTRATE FILLING DISTAL TO THE INTRA-LUMINAL THROMBUS. THERE IS SOME IMPROVEMENT IN FLOW. THE PREVIOUSLY IDENTIFIED FILLING DEFECT IN THE ACA CIRCULATION REMAINS PRESENT. THERE IS REASONABLE RESTORATION OF FLOW TIMI II GRADE. RIGHT COMMON CAROTID ARTERY: AP, LATERAL CERVICAL ANGIOGRAMS DEMONSTRATE A DISSECTION OF THE CERVICAL INTERNAL CAROTID ARTERY AT THE LEVEL OF THE GUIDING CATHETER BALLOON. FINAL CERVICAL ANGIOGRAMS DEMONSTRATE PLACEMENT OF A STENT ACROSS THE CERVICAL DISSECTION. THERE IS NO EVIDENCE OF STENOSIS. IMPRESSION OF THE CASE INDICATED AN ACUTE EMBOLIC STROKE WITH M-1 OCCLUSION AND DISTAL (ACA) ANTERIOR COMMUNICATING ARTERY EMBOLUS STATUS POST MERCI CLOT RETRIEVAL WITH INTRACRANIAL STENTING AND THROMBOLYSIS AS WELL AS CERVICAL CAROTID STENTING WITH TIMI II RESTORATION OF FLOW. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00297 & 9616099-2010-00800. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT OFF LABEL USE OF A 4.5X22 ENTERPRISE STENT AS SALVAGE FOR FAILED OCCLUSIVE STROKE INTERVENTION ACHIEVED THE DESIRED EFFECT. IN ADDITION, A 5X30 PRECISE RX STENT WAS USED TO TREAT A CERVICAL INTERNAL CAROTID DISSECTION WHICH OCCURRED AFTER NONCORDIS MERCI GUIDE CATHETER BALLOON WAS INFLATED. THE PATIENT STATUS AFTER THE PROCEDURE WAS UNCHANGED. AFTER THE PROCEDURE, THE PATIENT WAS DISCHARGED TO REHABILITATION FOR 7 DAYS. FURTHER INFORMATION WAS RECEIVED BY THE SITE THAT THE PATIENT EXPIRED APPROXIMATELY ONE MONTH AFTER THE INDEX PROCEDURE. THE DEATH CERTIFICATE IS NOT AVAILABLE, AND THE CAUSE OF DEATH IS UNKNOWN. THE INFORMATION REPORTED FROM THE ACCOUNT WAS RECEIVED VIA AN OBITUARY COLUMN OF LOCAL NEWSPAPER; NO FURTHER INFORMATION REGARDING THE DEATH IS AVAILABLE. IT WAS REPORTED THAT THE PATIENT DIED AFTER LEAVING THE HOSPITAL AND WAS LIKELY UNRELATED TO THE INTERVENTION. THE PATIENT WAS COMPLIANT WITH DISCHARGED MEDICATIONS. PRIOR TO INDEX PROCEDURE, THE PATIENT WAS FOUND DOWN IN THE FIELD AND ADMITTED WITH AN ACUTE STROKE WITH RIGHT MCA M1 OCCLUSION, PRESENTING WITH SUDDEN ONSET OF LEFT-SIDED HEMIPLEGIA. THE EXACT TIME OF ONSET WAS NOT KNOWN. NIH STROKE SCALE SCORE WAS 22. ANGIOGRAPHY DEMONSTRATED COMPLETE OCCLUSION OF THE RIGHT MCA DISTAL TO THE M1 SEGMENT. USING AN 8 FR CONCENTRIC BALLOON GUIDECATHETER, AN 18 L MICROCATHETER OVER A SYNCHRO 14 MICROWIRE, AND DAC CATHETER, THREE PASSES OF A MERCI CLOT RETRIEVER WERE MADE. THERE WAS PERSISTENT CLOT BURDEN IN THE M2 SEGMENT. ADDITIONALLY, THERE WAS A RIGHT INTERNAL CAROTID (ICA) DISSECTION NOTED. THE DAC CATHETER WAS REMOVED AND A PROWLER SELECT PLUS MICROCATHETER WAS ADVANCED INTO THE SUPERIOR M2 BRANCH. A 4.5X22 MM ENTERPRISE STENT WAS DEPLOYED ACROSS THE CLOTS. ANGIOGRAMS OF PERFORMED FOLLOWING STENT DEPLOYMENT DEMONSTRATE RECONSTITUTION OF FLOW INTO THAT DIVISION. THE ANTERIOR DIVISION SHOWED A PERSISTENT CLOT BURDEN. THIS WAS CROSSED USING THE MICROCATHETER WITH INSTILLATION OF 6 MG OF REOPRO THROMBOLYSIS IN TO THE CLOT. IV REOPRO WAS ALSO GIVEN. THE MICROCATHETER WAS REMOVED OVER AN EXCHANGE LENGTH TRANSCEND WIRE. GUIDE CATHETER WAS DRAWN PROXIMALLY. CERVICAL CAROTID ANGIOGRAMS WERE PERFORMED. A 5 X 30 PRECISE RX STENT WAS THEN DEPLOYED ACROSS THE CERVICAL CAROTID DISSECTION. THERE WAS NO EVIDENCE OF STENOSIS POST STENT PLACEMENT. ANGIOGRAMS FOLLOWING THE INFUSION OF REOPRO DEMONSTRATED FILLING DISTAL TO THE INTRA-LUMINAL THROMBUS. THERE IS SOME IMPROVEMENT IN FLOW. THE PREVIOUSLY IDENTIFIED FILLING DEFECT IN THE ANTERIOR CEREBRAL ARTERY CIRCULATION REMAINED PRESENT. THERE WAS REASONABLE RESTORATION OF FLOW TIMI II GRADE. AFTER POST PROCEDURAL CT IMAGING, THE PATIENT WAS TAKEN TO THE ICU FOR ADDITIONAL CARE. THE DEVICES REMAIN IMPLANTED AND, THEREFORE, ARE NOT AVAILABLE FOR ANALYSIS. THE LOT NUMBER OF THE PRECISE IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. BASED ON THE LACK OF INFORMATION PERTAINING TO THE PATIENT'S DEATH ONE MONTH POST OFF-LABEL USE OF THE ENTERPRISE VRD AND USE OF PRECISE STENT TO TREAT A DISSECTION, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE DEVICES TO THE REPORTED DEATH. AS REPORTED, THERE IS NO INDICATION OF ANY INTRA OR POST PROCEDURE COMPLICATIONS OR DEVICE PERFORMANCE ISSUES RELATED TO THE USE OF THE CORDIS PRODUCTS OR CONTRIBUTING TO THE EVENT. IT IS POSSIBLE THAT THE PATIENT COMORBIDITIES AND BASELINE STATUS CONTRIBUTED; HOWEVER, NO CONCLUSION CAN BE MADE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2010-00297 AND 9616099-2010-00800.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT A PATIENT WHO RECEIVED AN ENTERPRISE STENT ( 4.5 X 22 ENTERPRISE STENT, (B)(4), LOT # 1422400) EXPIRED APPROXIMATELY A MONTH AFTER THE INDEX PROCEDURE. THE DEATH CERTIFICATE IS NOT AVAILABLE, AND THE CAUSE OF DEATH IS UNKNOWN. THE INFORMATION REPORTED FROM THE ACCOUNT WAS RECEIVED VIA AN OBITUARY COLUMN OF LOCAL NEWSPAPER. AFTER THE PROCEDURE, THE PATIENT WAS DISCHARGED TO REHABILITATION FOR 7 DAYS AFTER INTERVENTION. DEATH HAPPENED AFTER SHE LEFT THE HOSPITAL, LIKELY UNRELATED TO INTERVENTION. THE INDEX PROCEDURE WAS CONDUCTED FOR ACUTE (RMCA) RIGHT MIDDLE CEREBRAL ARTERY OCCLUSION, REFRACTORY TO MERCI DEVICE, AND ENTERPRISE USE AS OFF LABEL AS SALVAGE FOR FAILED STROKE INTERVENTION. ADDITIONALLY, CERVICAL INTERNAL CAROTID STENT (PRECISE RX STENT 5X30) WAS CONDUCTED TO TREAT A DISSECTION. THE PATIENT WAS COMPLIANT WITH DISCHARGED MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death