BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 7512243 · Received May 14, 2018

    Report

    Report Number
    1226348-2018-00591
    Event Type
    Injury
    Date Received
    May 14, 2018
    Date of Event
    July 21, 2015
    Report Date
    April 19, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WORLD NEUROSURG. (2016) 91: 218-227. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.04.024 ¿MAGNETIC RESONANCE IMAGING FOLLOW-UP OF LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS AFTER TOTAL EMBOLIZATION ON ANGIOGRAPHY.¿ DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBER PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. (B)(6). [COMPLAINT CONCLUSION]: THE EVENT WAS CAPTURED IN THE LITERATURE PUBLICATION WORLD NEUROSURG. (2016) 91: 218-227. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.04.024 ¿MAGNETIC RESONANCE IMAGING FOLLOW-UP OF LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS AFTER TOTAL EMBOLIZATION ON ANGIOGRAPHY.¿ IT WAS REPORTED THAT A (B)(6) MALE PATIENT FROM ¿CASE 4¿ WHO HAD A RECURRENT VERTEBRAL ARTERY DISSECTING ANEURYSM WAS ADMITTED TO THE STUDY INSTITUTION (DEPARTMENT OF NEUROSURGERY, (B)(6) HOSPITAL OF (B)(6)) ON (B)(6) 2015. THE PATIENT REPORTED HOARSENESS AND DYSPHAGIA FOR 4 YEARS AND HAVE BEEN HAVING AN UNSTABLE GAIT FOR 1 YEAR. HIGH-RESOLUTION MAGNETIC RESONANCE (MRI) IMAGES WERE OBTAINED FROM 2 YEARS EARLIER SHOWED A DISSECTING ANEURYSM ON THE V4 SEGMENT OF THE RIGHT VERTEBRAL ARTERY, WHICH PROMPTED THE RECONSTRUCTIVE ENDOVASCULAR REPAIR PROCEDURE WITH 2 OVERLAPPED STENTS (ENTERPRISE 4.5 X 37 MM AND SOLITAIRE AB, 6 X 30 MM). ON (B)(6) 2015, THE PATIENT UNDERWENT THE INTERNAL TRAPPING WITH COILS AFTER WHICH THE UNSTABLE GAIT SYMPTOM WAS PARTIALLY ALLEVIATED FOR APPROXIMATELY 1 MONTH; HOWEVER, IT WORSENED AND THE PATIENT PRESENTED WITH NUMBNESS OF THE LIMBS 3 MONTHS AFTER THE SECOND PROCEDURE. PERSISTENT HEMORRHAGIC SIGNALS IN THE DISSECTING WALL WERE OBSERVED ON THE HIGH-RESOLUTION MRI AT FOLLOW-UP. CONSERVATIVE THERAPY WAS ELECTED BUT THE PATIENT¿S SYMPTOMS DID NOT IMPROVE. THERE WAS NO DEVICE SPECIFIC INFORMATION (INCLUDING DEVICE CATALOG AND LOT NUMBER) PROVIDED IN THE ARTICLE. THE STUDY RETROSPECTIVELY ANALYZED AND EVALUATED 4 PATIENTS WHO HAD UNRUPTURED LARGE OR GIANT VBDAS THAT WERE TREATED WITH ENDOVASCULAR TECHNIQUES WITH TOTAL EMBOLIZATION OF THE ANEURYSMS BETWEEN NOVEMBER 2011 AND JULY 2015, CONFIRMED ON FOLLOW-UP ANGIOGRAPHY, BUT HAD UNRELIEVED OR WORSENED SYMPTOMS. 3T HIGH-RESOLUTION MRS IMAGES OF BEFORE AND AFTER TREATMENT WERE EVALUATED TO ASSESS ARTERIAL WALL EVOLUTION. PATIENTS MEDICATION WAS DETERMINED DEPENDING ON THE ENDOVASCULAR PROCEDURE PERFORMED. IF RECONSTRUCTIVE ENDOVASCULAR PROCEDURES WERE CHOSEN, THE PATIENT WAS PRE-MEDICATED WITH A DUAL ANTIPLATELET REGIMEN OF 75 MG CLOPIDOGREL AND 100 MG ASPIRIN DAILY FOR 5 DAYS BEFORE THE TREATMENT PROCEDURE THEN RECEIVED THE STENT-ASSISTED COILING OR PLACEMENT OF A STENT WITHOUT COILS. BOTH THE DISSECTING ANEURYSM AND THE PARENT ARTERY WERE OCCLUDED WITH COILS IF THE INTERNAL TRAPPING TECHNIQUE WAS CHOSEN. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND MAGNETIC RESONANCE ANGIOGRAPHY (MRA) WERE USED TO ANALYZE LUMEN EVOLUTION. MRI OR HIGH-RESOLUTION MRI OF BEFORE AND AFTER TREATMENT WAS USED TO ANALYZE VESSEL WALL EVOLUTION. HETEROGENOUS SIGNAL INTENSITIES IN THE ANEURYSM WALL AND THE ¿ONION SKIN-LIKE¿ ASPECT OF THE ANEURYSM WITH THICKENING WALL SUGGEST THE PRESENCE OF A PARTIALLY THROMBOSED IMH AT DIFFERENT STAGES OF EVOLUTION. DURING FOLLOW-UP, THE PRESENCE OF AN INCREASED DIAMETER OF THE DISSECTING ANEURYSM WAS NOTED AND COMPARED WITH THE DIAMETER OF THE ANEURYSM BEFORE THE ENDOVASCULAR PROCEDURE. LESION ENHANCEMENT PATTERNS WERE ANALYZED IF GADOLINIUM WAS USED. RESULTS OF ARTERY LUMEN ASSESSMENT BY ANGIOGRAPHY SHOWED THAT ALL 4 PATIENTS SHOWED RELATIVELY SATISFACTORY RESULTS DURING FOLLOW-UP. THE (B)(6) MALE PATIENT FROM ¿CASE 4¿ TREATED BY INTERNAL TRAPPING WITH COILS AT 3 MONTHS FOLLOW-UP SHOWED THAT ANEURYSM AND DISSECTING ARTERIES WERE COMPLETELY OCCLUDED. CLINICAL RESULTS FOR THE PATIENT IN ¿CASE 4¿ AT 3-MONTH FOLLOW-UP IMAGING WAS WORSENED AFTER THE PATIENT HAD UNDERGONE THE INTERNAL TRAPPING WITH COILS PROCEDURE. THE RESULT OF ARTERIAL WALL ASSESSMENT BY HIGH-RESOLUTION MRI FOR THE PATIENT IN ¿CASE 4¿ AT 3 MONTHS SHOWED AN ENLARGED ANEURYSM. LUMINAL RECONSTRUCTION OR OCCLUSION HAVE BEEN THE FOCUS OF MOST REPORTS FOLLOWING PROCEDURES. HOWEVER, IT IS NOT KNOWN WHETHER ARTERIAL WALL REMAINS STABLE, RECOVERS, OR BECAME PROGRESSIVELY WORSEN AFTER SUCCESSFUL ENDOVASCULAR TREATMENT. THE 4 CASES IN THIS STUDY HAD FOLLOW-UP ANGIOGRAPHY THAT CONFIRMED SATISFACTORY LUMINAL RESULTS, BUT FOLLOW-UP WITH HIGH-RESOLUTION MRI SHOWED NEW HEMATOMA OR PERSISTENT EXISTENCE OF HEMORRHAGIC SIGNALS IN THE DISSECTING WALL AND IN 3 OF THE 4 CASES ¿ INCREASED ANEURYSM SIZE. THE RESULTS CAPTURE A DISCREPANCY BETWEEN THE ARTERIAL WALL AND THE LUMEN AFTER ENDOVASCULAR TREATMENT THAT MIGHT BE A REASON TO RE-EVALUATE THE EFFICACY OF THE TREATMENT FOR THESE LESIONS. THE FORMATION OF AN IMH IS A CRITICAL EVENT NECESSARY FOR A DISSECTING ANEURYSM TO PROGRESS; THIS CAN BE MONITORED ON MRI. RECURRENT IMH CAN CAUSE DISSECTING ANEURYSMS TO GROW OR RUPTURE, BUT THE MECHANISM IS UNCLEAR. ONE OF THE HYPOTHESES APPLICABLE TO THE PATIENT IN ¿CASE 4¿ WHERE THE ANEURYSM CONTINUED TO GROW DUE TO THE PERSISTENT IMH EVEN AFTER THEIR PARENT VESSELS HAVE BEEN SACRIFICED IS THE RUPTURE OF THE VASA VASORUM IN THE ANEURYSM WALL. WHEN A SUFFICIENT LEVEL OF INTIMAL THICKENING IS REACHED, THAT PREVENT FURTHER MEDIAL DISSECTION AND NEOVASCULARIZATION BEGINS WITHIN THE THICKENED INTIMAE. NEW VESSELS IN THE INTIMAE APPEAR TO BE FRAGILE AND RESULT IN REPETITIVE IMH, WHICH IN TURN LEADS TO CHRONICALLY ENLARGING ANEURYSMS. INTERNAL TRAPPING WITH COILS HAS BEEN PROVEN TO BE A STABLE AND DURABLE TREATMENT FOR CLOSURE OF VBDAS, BUT IT REQUIRES ADEQUATE COLLATERAL FLOW AND INVOLVEMENT OF AN IMPORTANT PERFORATING BRANCH ARTERY IS A CONTRAINDICATION. THE DISSECTING ARTERY IN THE PATIENT IN ¿CASE 4¿ WAS COMPLETELY OCCLUDED AFTER UNDERGOING INTERNAL TRAPPING WITH COILS, BUT THE PATIENT HAD AN INCREASED IN ANEURYSM SIZE AND WORSEN SYMPTOMS AT FOLLOW-UP. THE PATIENT IN ¿CASE 4¿ WAS INITIALLY TREATED WITH STENT-ASSISTED COILING, WHICH IS WIDELY USED IN THE TREATMENT OF VBDAS, HOWEVER, FOR LARGE OR GIANT VBDAS, THE RECURRENCE RATE OF STENT-ASSISTED COILING IS RELATIVELY HIGH. AS A RESULT, THE PATIENT HAD RECANALIZATION AND UNDERWENT INTERNAL TRAPPING WITH COILS; THE PATIENT MIGHT HAVE HAD A FAVORABLE OUTCOME IF THE INITIAL PROCEDURE WAS INTERNAL TRAPPING WITH COILS. THE RARITY OF LARGE OR GIANT VBDAS IS THE LIMITATION OF THIS STUDY AS IT RESULTED IN ONLY 4 CASES ANALYZED. A PROSPECTIVE, MULTICENTER INVESTIGATION WITH A LARGE SAMPLE SIZE IS WARRANTED. THE STUDY CONCLUDED THAT THE EFFICACY OF CONVENTIONAL ENDOVASCULAR TREATMENT FOR LARGE OR GIANT VBDAS IS UNCERTAIN. ANGIOGRAPHY-ONLY AT FOLLOW-UP DOES NOT PROVIDE ADEQUATE PREDICTION OF OUTCOME. A WORTHWHILE ADJUNCT TO FOLLOW THESE LESIONS IS HIGH-RESOLUTION MRI. THE ENTERPRISE STENT REMAINED IMPLANTED AND IS THUS NOT AVAILABLE TO BE RETURNED 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. NEUROLOGICAL DEFICIT IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE ENTERPRISE VRD AND STENT-ASSISTED COIL EMBOLIZATION PROCEDURES. THE PUBLICATION STATES THAT PATIENTS WITH LARGE OR GIANT VBDAS ARE CLINICALLY CHALLENGING. THE NATURAL HISTORY IS POOR, ESPECIALLY WHEN THE ANEURYSM IS SYMPTOMATIC BY MASS EFFECT. DISSECTING ANEURYSMS MAY CONTINUE TO GROW BECAUSE OF THE PERSISTENT IMH EVEN AFTER THEIR PARENT VESSELS HAVE BEEN SACRIFICED. ANOTHER HYPOTHESIS FOR RECURRENT IMH IS RUPTURE OF THE VASA VASORUM IN THE ANEURYSM WALL. WHEN INTIMAL THICKENING REACHES A SUFFICIENT LEVEL TO PREVENT FURTHER MEDIAL DISSECTION, NEOVASCULARIZATION BEGINS WITHIN THE THICKENED INTIMAE. THE NEW VESSELS WITHIN THE INTIMAE APPEAR TO BE FRAGILE AND CAUSE REPETITIVE IMH, WHICH LEADS TO CHRONICALLY ENLARGING ANEURYSMS. THIS HYPOTHESIS CAN EXPLAIN WHY CONTINUOUS IMH WAS PRESENT IN THIS CASE. DESPITE ENDOVASCULAR TREATMENT, THE ANEURYSM ENLARGED AND SYMPTOMS WORSENED. 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. IN ADDITION, IT PRECAUTIONS THAT THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPED STENTS HAS NOT BEEN ESTABLISHED. THE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL FACTORS AND THE COMPLEX NATURE OF THE PATIENT¿S UNDERLYING DISEASE MAY HAVE CONTRIBUTED TO THE EVENT. THE NEUROLOGICAL DEFICIT IS SERIOUS/LIFE-THREATENING, REQUIRED CONSERVATIVE TREATMENT, AND THE RELATIONSHIP OF THE EVENT TO THE DEVICE OR PROCEDURE CANNOT BE EXCLUDED. THUS, THE EVENT MEETS THE CRITERIA FOR MDR REPORTING AS A SERIOUS INJURY. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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

    THE EVENT WAS CAPTURED IN THE LITERATURE PUBLICATION WORLD NEUROSURG. (2016) 91: 218-227. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.04.024 ¿MAGNETIC RESONANCE IMAGING FOLLOW-UP OF LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS AFTER TOTAL EMBOLIZATION ON ANGIOGRAPHY.¿ IT WAS REPORTED THAT A (B)(6) MALE PATIENT FROM ¿CASE 4¿ WHO HAD A RECURRENT VERTEBRAL ARTERY DISSECTING ANEURYSM WAS ADMITTED TO THE STUDY INSTITUTION (DEPARTMENT OF NEUROSURGERY, (B)(6) HOSPITAL OF (B)(6)) ON (B)(6) 2015. THE PATIENT REPORTED HOARSENESS AND DYSPHAGIA FOR 4 YEARS AND HAVE BEEN HAVING AN UNSTABLE GAIT FOR 1 YEAR. HIGH-RESOLUTION MAGNETIC RESONANCE (MRI) IMAGES WERE OBTAINED FROM 2 YEARS EARLIER SHOWED A DISSECTING ANEURYSM ON THE V4 SEGMENT OF THE RIGHT VERTEBRAL ARTERY, WHICH PROMPTED THE RECONSTRUCTIVE ENDOVASCULAR REPAIR PROCEDURE WITH 2 OVERLAPPED STENTS (ENTERPRISE 4.5 X 37 MM AND SOLITAIRE AB, 6 X 30 MM). ON (B)(6) 2015, THE PATIENT UNDERWENT THE INTERNAL TRAPPING WITH COILS AFTER WHICH THE UNSTABLE GAIT SYMPTOM WAS PARTIALLY ALLEVIATED FOR APPROXIMATELY 1 MONTH; HOWEVER, IT WORSENED AND THE PATIENT PRESENTED WITH NUMBNESS OF THE LIMBS 3 MONTHS AFTER THE SECOND PROCEDURE. PERSISTENT HEMORRHAGIC SIGNALS IN THE DISSECTING WALL WERE OBSERVED ON THE HIGH-RESOLUTION MRI AT FOLLOW-UP. CONSERVATIVE THERAPY WAS ELECTED BUT THE PATIENT¿S SYMPTOMS DID NOT IMPROVE. THERE WAS NO DEVICE SPECIFIC INFORMATION (INCLUDING DEVICE CATALOG AND LOT NUMBER) PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355201 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR