BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 7603941 · Received June 14, 2018

    Report

    Report Number
    1226348-2018-00614
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    January 1, 2016
    Report Date
    May 23, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LITERATURE COMPLAINT WAS FOUND DURING A RECENT POST-MARKET SURVEILLANCE REVIEW OF THIS DEVICE. THE CITATION OF THE PUBLICATION IS AS FOLLOWS: OTA, TAKAHIRO, ET AL. ¿RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF RUPTURED VERTEBRAL ARTERY DISSECTION INVOLVING THE POSTERIOR INFERIOR CEREBELLAR ARTERY.¿ ACTA NEUROCHIRURGICA, VOL. 158, NO. 6, JAN. 2016, PP. 1089¿1093., DOI:10.1007/S00701-016-2788-2. DUE TO THE NATURE OF THE COMPLAINT, THE STERILE LOT NUMBER WAS NOT PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. DATE OF EVENT: THE ARTICLE WAS PUBLISHED IN (B)(6) 2016; THEREFORE, THE DATE OF THE EVENT WAS ENTERED AS (B)(6) 2016. (B)(6). MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF RUPTURED VERTEBRAL ARTERY DISSECTION INVOLVING THE POSTERIOR INFERIOR CEREBELLAR ARTERY¿, A (B)(6) MALE PRESENTED WITH SUDDEN SEVERE HEADACHE AND VOMITING. COMPUTED TOMOGRAPHY (CT) ON ADMISSION REVEALED MASSIVE SUBARACHNOID HEMORRHAGE (SAH), WORLD FEDERATION OF NEUROSURGICAL SOCIETIES (WFNS) GRADE II. CEREBRAL ANGIOGRAPHY DEMONSTRATED FUSIFORM DILATION OF THE RIGHT VERTEBRAL ARTERY (VA) ASSOCIATED WITH THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ORIGIN. ENDOVASCULAR COIL OCCLUSION OF THE LEFT VA PROXIMAL TO THE ORIGIN OF THE PICA WAS PERFORMED ON DAY 0, AND POSTOPERATIVE MAGNETIC RESONANCE (MRI) SHOWED NO INFARCTION IN THE MEDULLA OR CEREBELLUM. FOLLOW-UP ANGIOGRAPHY SHOWED ENLARGEMENT OF THE RESIDUAL DISSECTION, SO A SECOND ENDOVASCULAR THERAPY WAS PERFORMED ON DAY 25. AN ENTERPRISE 4.5 MM× 14 MM STENT WAS PLACED FROM THE RIGHT PICA TO THE RIGHT VA FROM A CONTRALATERAL APPROACH. THE SITE EXPECTED A FLOW-DIVERSION EFFECT ON STENT PLACEMENT, SO COIL EMBOLIZATION WAS NOT ADDED. HOWEVER, THE DOME SHOWED GRADUAL ENLARGEMENT OVER 6 MONTHS, SO BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED. FOLLOW-UP ANGIOGRAPHY 10 MONTHS AFTER ONSET SHOWED COIL COMPACTION, SO DUAL ANTIPLATELET THERAPY WAS CHANGED TO SINGLE ANTIPLATELET THERAPY. ANGIOGRAPHY AFTER 16 MONTHS SHOWED THE ANEURYSM WAS STABLE. THE PURPOSE OF THE STUDY WAS TO REVIEW THE SAFETY AND LONG-TERM EFFICACY OF ENDOVASCULAR TREATMENT FOR PICA INVOLVING VA DISSECTION, WITH SPECIAL EMPHASIS ON MANAGEMENT OUTCOMES OF OUR NOVEL STAGED, COMBINED THERAPY COMPRISING PROXIMAL OCCLUSION OF THE VA IN THE ACUTE STAGE AND PICA-TO-VA STENTING WITH COIL EMBOLIZATION FROM THE CONTRALATERAL APPROACH IN THE CHRONIC STAGE. THE STUDY CONCLUDED THAT IN THE TREATMENT OF RUPTURED PICA INVOLVING VA DISSECTION, STAGED, COMBINED THERAPY USING PROXIMAL OCCLUSION OF THE VA IN THE ACUTE STAGE AND PICA-TO-VA STENTING WITH COIL EMBOLIZATION FROM A CONTRALATERAL APPROACH IN THE CHRONIC STAGE MIGHT OFFER A VALUABLE TREATMENT OPTION TO PRESERVE PICA PATENCY. THERE WAS NO DEVICE-SPECIFIC INFORMATION PROVIDED IN THE ARTICLE, INCLUDING DEVICE CATALOG AND LOT NUMBER. NO FURTHER INFORMATION WAS PROVIDED. THE ENTERPRISE STENT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE STERILE LOT NUMBER IS NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. ANEURYSM RECANALIZATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE ENTERPRISE VRD AND STENT-ASSISTED COIL EMBOLIZATION PROCEDURES. AS OUTLINED IN THE IFU, THE INDICATED USE OF THE ENTERPRISE VRD IS TO PREVENT COILS FROM PROTRUDING OUT OF THE ANEURYSM INTO THE PARENT ARTERY. IT IS LISTED IN THE PRECAUTIONS THAT THE ENTERPRISE VRD IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E. WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM. THE RECOMMENDED PARENT VESSEL DIAMETER OR USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE IS 2.5MM ¿ 4.0MM. RECURRENCE HAS POSED A GREAT CHALLENGE TO RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF INTRACRANIAL VADAS. THERE IS A 13¿33% RECURRENCE RATE AFTER ENDOVASCULAR TREATMENT OF VBDAS. ON FOLLOW UP ANGIOGRAPHY FOR 97 VBDAS IN 89 PATIENTS AFTER ENDOVASCULAR TREATMENT, KIM ET AL. FOUND THAT PICA ORIGIN INVOLVEMENT WAS THE ONLY INDEPENDENT RISK FACTOR FOR RECURRENCE. PERSISTENT BLOOD FLOW THROUGH THE UNPROTECTED REMNANT DISSECTING ANEURYSM TOWARD THE PICA WAS BELIEVED TO BE THE REASON OF RECURRENCE. DIFFERING FROM DECONSTRUCTIVE TREATMENT THAT OBLITERATES THE PARENT ARTERY, SAC, AS A RECONSTRUCTIVE TREATMENT MODALITY, MAINTAINS THE BLOOD FLOW OF PARENT ARTERY INCREASING THE POSSIBILITY OF RECURRENCE. WITH THE INCREASE OF BLOOD FLOW, FROM THE DEFECTS OF THE INTIMA, DISSECTING ANEURYSMS CAN GROW CONTINUOUSLY. THE ROOT CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT THE GEOMETRIC COMPLEXITY AND FLOW DYNAMICS CHANGES IN DISSECTING ANEURYSMS MAY HAVE CONTRIBUTED TO THE EVENT. ADEQUATE FLOW DIVERSION AND DENSE PACKING ARE EQUALLY SIGNIFICANT TO AVOID RECURRENCE. DENSE COIL PACKING IS CRUCIAL TO DECREASE THE RATE OF RECURRENCE. HOWEVER, FOR DISSECTING ANEURYSM WITH IRREGULAR SHAPE AND COMPLEX GEOMETRY, PLUS FRAGILE VESSEL WALL, AND WITHOUT DEFINITE ANEURYSM NECK, IT IS DIFFICULT AND CHALLENGING TO PERFORM COMPLETE OCCLUSION. PERSISTENT BLOOD FLOW INTO DISSECTING ANEURYSM, NOT COMPLETELY OBLITERATED, WILL RESULT IN RECURRENCE OF THE DISSECTING ANEURYSMS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF RUPTURED VERTEBRAL ARTERY DISSECTION INVOLVING THE POSTERIOR INFERIOR CEREBELLAR ARTERY¿, A(B)(6) MALE PRESENTED WITH SUDDEN SEVERE HEADACHE AND VOMITING. COMPUTED TOMOGRAPHY (CT) ON ADMISSION REVEALED MASSIVE SUBARACHNOID HEMORRHAGE (SAH), WORLD FEDERATION OF NEUROSURGICAL SOCIETIES (WFNS) GRADE II. CEREBRAL ANGIOGRAPHY DEMONSTRATED FUSIFORM DILATION OF THE RIGHT VERTEBRAL ARTERY (VA) ASSOCIATED WITH THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ORIGIN. ENDOVASCULAR COIL OCCLUSION OF THE LEFT VA PROXIMAL TO THE ORIGIN OF THE PICA WAS PERFORMED ON DAY 0, AND POSTOPERATIVE MAGNETIC RESONANCE (MRI) SHOWED NO INFARCTION IN THE MEDULLA OR CEREBELLUM. FOLLOW-UP ANGIOGRAPHY SHOWED ENLARGEMENT OF THE RESIDUAL DISSECTION, SO A SECOND ENDOVASCULAR THERAPY WAS PERFORMED ON DAY 25. AN ENTERPRISE 4.5 MM× 14 MM STENT WAS PLACED FROM THE RIGHT PICA TO THE RIGHT VA FROM A CONTRALATERAL APPROACH. THE SITE EXPECTED A FLOW-DIVERSION EFFECT ON STENT PLACEMENT, SO COIL EMBOLIZATION WAS NOT ADDED. HOWEVER, THE DOME SHOWED GRADUAL ENLARGEMENT OVER 6 MONTHS, SO BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED. FOLLOW-UP ANGIOGRAPHY 10 MONTHS AFTER ONSET SHOWED COIL COMPACTION, SO DUAL ANTIPLATELET THERAPY WAS CHANGED TO SINGLE ANTIPLATELET THERAPY. ANGIOGRAPHY AFTER 16 MONTHS SHOWED THE ANEURYSM WAS STABLE. THE PURPOSE OF THE STUDY WAS TO REVIEW THE SAFETY AND LONG-TERM EFFICACY OF ENDOVASCULAR TREATMENT FOR PICA INVOLVING VA DISSECTION, WITH SPECIAL EMPHASIS ON MANAGEMENT OUTCOMES OF OUR NOVEL STAGED, COMBINED THERAPY COMPRISING PROXIMAL OCCLUSION OF THE VA IN THE ACUTE STAGE AND PICA-TO-VA STENTING WITH COIL EMBOLIZATION FROM THE CONTRALATERAL APPROACH IN THE CHRONIC STAGE. THE STUDY CONCLUDED THAT IN THE TREATMENT OF RUPTURED PICA INVOLVING VA DISSECTION, STAGED, COMBINED THERAPY USING PROXIMAL OCCLUSION OF THE VA IN THE ACUTE STAGE AND PICA-TO-VA STENTING WITH COIL EMBOLIZATION FROM A CONTRALATERAL APPROACH IN THE CHRONIC STAGE MIGHT OFFER A VALUABLE TREATMENT OPTION TO PRESERVE PICA PATENCY. THERE WAS NO DEVICE-SPECIFIC INFORMATION PROVIDED IN THE ARTICLE, INCLUDING DEVICE CATALOG AND LOT NUMBER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445291 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R