BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2082458 · Received May 10, 2011

    Report

    Report Number
    1058196-2011-00217
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    December 3, 2010
    Report Date
    April 11, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) AND CORDIS LOT NUMBER 01425608. PER (B)(6) REPORT (B)(4), (B)(6) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425608. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH (B)(6) INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THIS PACKAGING LOT CONTAINED 50 UNITS, WHICH WERE SHIPPED FROM (B)(6) ON (B)(6) 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(6) AND WAS DETERMINED TO BE ACCEPTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED THAT REPORTING THAT POST THROMBECTOMY, ANGIOPLASTY, THROMBOLYSIS, AND OFF-LABEL USE OF THE ENTERPRISE VRD FOR EMERGENCY STROKE TREATMENT WITHOUT SUCCESSFUL SUSTAINED REVASCULARIZATION, THE PATIENT DIED. THERE IS NO FURTHER INFORMATION REGARDING THE PATIENT'S DEATH. THE (B)(6) MALE HAD A HISTORY OF AORTIC DISSECTION AND TWO ARTIFICIAL VALVES; HOWEVER WAS NOT THERAPEUTIC ON COUMADIN AND MAY NOT HAVE BEEN TAKING IT AT ALL. THE PATIENT PRESENTED WITH ACUTE LEFT MCA SYNDROME WITH AN (B)(6) SCORE OF 20 AND WAS TRANSFERRED TO THE TREATING FACILITY WHERE A FULL DOSE OF IV TPA WAS GIVEN. DIAGNOSTIC IMAGES 80 MINUTES AFTER INITIAL PRESENTATION OF SYMPTOMS DEMONSTRATED LEFT M1 OCCLUSION, LEFT ANTERIOR 1/3 INFARCT, WITH MOST OF THE REMAINING MCA TERRITORY STILL VIABLE. ENDOVASCULAR INTERVENTION (DELAYED SECONDARY TO FAMILY INDECISION) WAS STARTED FOUR HOURS POST INITIAL SYMPTOMS. INITIAL ANGIOGRAPHY DEMONSTRATED AN M1 MCA OCCLUSION WITH POOR COLLATERAL. MECHANICAL THROMBECTOMY TO THE LEFT M1 MCA WAS PERFORMED MULTIPLE TIMES WITH A 041 PENUMBRA SYSTEM FOLLOWED BY ANGIOPLASTY WITH A 2MMX8MM APEX BALLOON MULTIPLE TIMES WITH NO SIGNIFICANT CHANGE IN FLOW NOTED. THE CLOT WAS HARD AND FIBROUS. POST ANGIOPLASTY #2 REPORTED M1 MCA OCCLUDED WITH POOR COLLATERAL AND THAT THERE MAY BE A SLIGHT AMOUNT OF EXTRAVASATION VS. CONTRAST IN AN OCCLUDED VESSEL THAT IS NOT WASHING OUT. THERE WAS PATENCY OF THE M2 MCA POSTERIOR DIVISION. THIS WAS FOLLOWED BY ADMINISTRATION OF 4MG OF TPA VIA AN SL-10 MICROCATHETER. A PROWLER PLUS WAS THEN NAVIGATED INTO THE LEFT MCA POSTERIOR DIVISION. STENT THROMBECTOMY WAS PERFORMED; THE ENTERPRISE VRD WAS PARTIALLY DEPLOYED. MINIMAL BLOOD FLOW WAS RESTORED. IT WAS ELECTED NOT TO IMPLANT THE STENT PERMANENTLY DUE TO THE HIGH RISK OF HEMORRHAGE. CONTROL ANGIOGRAPHY DEMONSTRATED NO SUSTAINED FLOW. POST STENT PARTIAL DEPLOYMENT REPORTED M1 MCA NOW SUPPLIED THE LEFT M2 POSTERIOR DIVISION WITH POOR DIRECT FLOW. POST STENT RETRIEVAL ANGIOGRAPHY DEMONSTRATED THE M1 MCA IS OCCLUDED WITH POOR COLLATERAL AND NO CHANGE IN THE FINAL ANGIOGRAPHY. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425608. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS OUTLINED IN THE INSTRUCTIONS FOR USE, THE ENTERPRISE VRD IS INTENDED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF WIDE-NECK, INTRACRANIAL, SACCULAR OR FUSIFORM ANEURYSMS. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. THE PATIENT'S BASELINE PRESENTATION, PRESENCE OF THROMBUS AND ATTEMPTED THROMBECTOMY USING MULTIPLE MODALITIES ARE ALL FACTORS POSSIBLY IMPACTING THE OUTCOME ASSOCIATED WITH THE OFF-LABEL USE OF THE ENTERPRISE VRD. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE, BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING OR PERFORMANCE ISSUES RELATED TO THE PATIENT PROCEDURAL OUTCOME AND SUBSEQUENT DEATH. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    TIMI FLOW PRE AND POST WAS 0. # PENUMBRA PRODUCTS WERE UTILIZED DURING THE PROCEDURE. THE PATIENT WAS ADMITTED FROM THE EMERGENCY DEPARTMENT WITH CHIEF COMPLAINT OF SUDDEN-ONSET RIGHT-SIDED WEAKNESS AND INABILITY TO SPEAK. THE PATIENT HAD A HISTORY OF DEPRESSION; ASCENDING THORACIC AORTA ANEURYSM, STATUS POST REPAIR ALONG WITH AORTIC VALVE REPAIR, PRESENTED IN ER ON (B)(6) 2010 EVENING WITH SUDDEN-ONSET APHASIA AND RIGHT-SIDED HEMIPLEGIA. PER THE PATIENT'S FIANCÉE, THE PATIENT WAS WATCHING TV ON BED AT 9:50 P.M. WHEN HE SUDDENLY DEVELOPED APHASIA AND HE TRIPPED LOWER TO GO TO THE BATHROOM AND FELL AND COULD NOT MOVE HIS RIGHT SIDE OF THE BODY. HIS FIANCEE CALLED 911, EMS SENT THE PATIENT TO (B)(6) HOSPITAL. CT SCAN WITH NO POSITIVE FINDINGS. THE PATIENT WAS TRANSFERRED TO (B)(6) FOR FURTHER STROKE MANAGEMENT, EMERGENCY DEPARTMENT, AND THE INITIAL (B)(6) WAS 21 AT 11:35, AND IV TPA WAS GIVEN AND WAS IMMEDIATELY EVALUATED BY NEURO-INTERVENTION ATTENDING FOR POSSIBLE INTRA-ARTERIAL THROMBOLYSIS. ON PREVIOUS HISTORY, THE PATIENT WAS SUPPOSED TO TAKE COUMADIN 10 MG Q. DAY, BUT (B)(6) IN THE EMERGENCY DEPARTMENT WAS NORMAL AT 1. PAST MEDICAL HISTORY: MVD. ANXIETY. 10S. HISTORY OF ASCENDING AORTA ANEURYSM WITH AORTIC VALVE REPAIR, ON COUMADIN, 2003. ALLERGIES: NO ALLERGY HISTORY. SOCIAL HISTORY: WORKED IN HOSPITAL ADMINISTRATION. QUIT SMOKING 2 YEARS AGO. DRANK BEER OCCASIONALLY. FAMILY HISTORY: SISTER HAD HEART DISEASE AT THE AGE OF (B)(6). REVIEW OF SYSTEMS: COULD NOT BE OBTAINED BECAUSE THE PATIENT WAS APHASIC. PHYSICAL EXAMINATION: VITAL SIGNS: BLOOD PRESSURE 182/81, PULSE 83, RESPIRATION 25, WEIGHT (B)(6). GENERAL: THE PATIENT WAS IN OBVIOUS DISTRESS WITH NO SKIN RASHES. EYES: RIGHT VISION FIELD CUT WITH PARTIAL GAZE. PARESIS (___) TO HAVE RIGHT FACIAL DROOP. NECK: SUPPLE. CHEST: CLEAR TO AUSCULTATION ALL OVER. CARDIOVASCULAR: REGULAR RATE AND RHYTHM. 216 SYSTOLIC MURMUR. ABDOMEN: SOFT, NONTENDER. BOWEL SOUNDS PRESENT ON ABDOMINAL EXAMINATION. NEUROLOGIC: THE PATIENT WAS ALERT, APHASIC, MORE EXPRESSIVE APHASIA THAN COMPREHENSION. FOLLOWED I -STEP SIMPLE COMMANDS. RIGHT FACIAL DROOP. RIGHT VISUAL FIELD CUT. RIGHT GAZE PREFERENCE. PARTIAL PARESIS OF THE RIGHT GAZE, RIGHT HEMIPLEGIA AND DECREASED PINPRICK SENSATION ON THE RIGHT SIDE. (B)(6) OF 21. PLEASE SEE FULL (B)(6) FORM FOR DETAILS. IMAGING: EMERGENCY CAT SCAN WITH BRAIN DEATH PROTOCOL WITH CTA AND CTP SHOWED THE PATIENT HAD LEFT MCA OCCLUSION WITH AT LEAST 20% TO 30% COMPLETED INFARCT AND WHOLE MCA TERRITORY AT RISK WITH INCREASED MEAN TRANSIT TIME AND NORMAL BLOOD VOLUME. INR WAS 1.08. PT WAS 14.4, PTT 32.2. OTHER ELECTROLYTES AND CBC WERE NORMAL. HOSPITAL COURSE: THE PATIENT UNDERWENT URGENT INTRA ARTERIAL THROMBOLYSIS BY DR. (B)(6) IN NEURO INTERVENTION SUITE WITHOUT SUCCESSFUL THROMBOLYSIS. THE PATIENT WAS INTUBATED FOR THE PROCEDURE AND REMAINED INTUBATED. AFTER THE PROCEDURE, THE PATIENT WAS AUTOMATICALLY TRANSFERRED TO THE (B)(6) FOR FURTHER MANAGEMENT. DURING HIS TREATMENT IN (B)(6), THE PATIENT WAS OBSERVED WITH CLOSE VITALS AND NEURO CHECKS FOR POSSIBLY DEVELOPING MALIGNANT LEFT MCA INFARCT. THE PATIENT WAS SOMEHOW STABLE IN INITIAL FEW DAYS; HOWEVER, ON THE DAY 6 MORNING POST-STROKE, THE PATIENT HAD SIGNS OF INCREASED INTRACRANIAL PRESSURE WITH DILATATION OF PUPIL IN THE LEFT SIDE AND NOT BEING FOLLOWING COMMANDS ON LEFT UPPER AND LOWER EXTREMITIES WHICH THE PATIENT WAS MOVING BEFORE THAT< FAMILY MADE TO PURSUE WITH MAXIMUM MEDICAL CARE AND NOT SURGERY HEMICRANIECTORNY AS HE HAD LEFT MCA TERRITORY STROKE WITH APHASIA. THE PATIENT WAS FURTHER MANAGED WITH MAXIMAL MEDICAL CARE FOR INCREASED INTRACRANIAL PRESSURE. ME WAS STARTED ON IV MANNITOL, 3% HYPERTONIC SALINE, AND HE WAS ALSO STARTED ON HYPOTHERMIA PROTOCOL. HE WAS COOLED FOR 4 DAYS AND GRADUALLY RE-WARMED. ICU TEAM HAD SEVERAL FAMILY MEETINGS REGARDING THE PROGNOSIS AND FURTHER CARE. FAMILY MEMBERS INCLUDING 2 SISTER, BROTHER AND FIANCÉ MADE THE DECISION FOR WITHDRAWAL CARE AFTER RE-WARMING. THE PATIENT WAS SLOWLY RE-WARMED. ON THE DAY THE PATIENT BECAME NORMOTHERMIC PATIENT, THE PATIENT REMAINED COMATOSE WITH ABSENT BRAIN STEM REFLEXES, HE DID NOT HAVE ANY SPONTANEOUS BREATHING, HIS BP DROPPED OFF PRESSORS, AND HIS PULSE STOPPED WITH ABSENCE OF HEART SOUNDS ON (B)(6) 2010, AT 1553, HENCE DEATH WAS DECLARED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MINIMAL BLOOD FLOW WAS RESTORED. IT WAS ELECTED NOT TO IMPLANT THE STENT PERMANENTLY DUE TO THE HIGH RISK OF HEMORRHAGE. CONTROL ANGIOGRAPHY DEMONSTRATED NO SUSTAINED FLOW. POST STENT PARTIAL DEPLOYMENT REPORTED M1 MCA NOW SUPPLIED THE LEFT M2 POSTERIOR DIVISION WITH POOR DIRECT FLOW. POST STENT RETRIEVAL ANGIOGRAPHY DEMONSTRATED THE M1 MCA IS OCCLUDED WITH POOR COLLATERAL AND NO CHANGE IN THE FINAL ANGIOGRAPHY. A 6 FRECNH SHEATH, 6 FRENCH DIAGNOSTIC CATHETER, APEX 2C8MM BALLOON, SL 10 MICROCATHETER, TRAXCESS MICROWIRE, AND PROWLER PLUS CATHETER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT POST THROMBECTOMY, ANGIOPLASTY, THROMBOLYSIS, AND OFF-LABEL USE OF THE ENTERPRISE VRD FOR EMERGENCY STROKE TREATMENT WITHOUT SUCCESSFUL SUSTAINED REVASCULARIZATION, THE PATIENT DIED. THERE IS NO FURTHER INFORMATION REGARDING THE PATIENT'S DEATH. THE (B)(6) MALE HAD A HISTORY OF AORTIC DISSECTION AND TWO ARTIFICIAL VALVES; HOWEVER WAS NOT THERAPEUTIC ON COUMADIN AND MAY NOT HAVE BEEN TAKING IT AT ALL. THE PATIENT PRESENTED WITH ACUTE LEFT MCA SYNDROME WITH AN NIHSS SCORE OF 20 AND WAS TRANSFERRED TO THE TREATING FACILITY WHERE A FULL DOSE OF IV TPA WAS GIVEN. DIAGNOSTIC IMAGES 80 MINUTES AFTER INITIAL PRESENTATION OF SYMPTOMS DEMONSTRATED LEFT M1 OCCLUSION, LEFT ANTERIOR 1/3 INFARCT, WITH MOST OF THE REMAINING MCA TERRITORY STILL VIABLE. ENDOVASCULAR INTERVENTION (DELAYED SECONDARY TO FAMILY INDECISION) WAS STARTED FOUR HOURS POST INITIAL SYMPTOMS. INITIAL ANGIOGRAPHY DEMONSTRATED AN M1 MCA OCCLUSION WITH POOR COLLATERAL. MECHANICAL THROMBECTOMY TO THE LEFT M1 MCA WAS PERFORMED MULTIPLE TIMES WITH A (B)(4) PENUMBRA SYSTEM FOLLOWED BY ANGIOPLASTY WITH A 2MMX8MM APEX BALLOON MULTIPLE TIMES WITH NO SIGNIFICANT CHANGE IN FLOW NOTED. THE CLOT WAS HARD AND FIBROUS. POST ANGIOPLASTY #2 REPORTED M1 MCA OCCLUDED WITH POOR COLLATERAL AND THAT THERE MAY BE A SLIGHT AMOUNT OF EXTRAVASATION VS CONTRAST IN AN OCCLUDED VESSEL THAT IS NOT WASHING OUT. THERE WAS PATENCY OF THE M2 MCA POSTERIOR DIVISION. THIS WAS FOLLOWED BY ADMINISTRATION OF 4MG OF TPA VIA AN SL-10 MICROCATHETER. A PROWLER PLUS WAS THEN NAVIGATED INTO THE LEFT MCA POSTERIOR DIVISION. STENT THROMBECTOMY WAS PERFORMED; THE ENTERPRISE VRD WAS PARTIALLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 01425608

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death