BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENVOY 6F

    MDR report key: 5871884 · Received August 12, 2016

    Report

    Report Number
    3008264254-2016-00046
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    May 23, 2016
    Report Date
    August 3, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    DQY
    PMA / PMN Number
    K093184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER DEVICES USED IN THE PROCEDURE: RADIOFOCUS 0.035" HYDROPHILIC GUIDEWIRE (TERUMO, (B)(4))< ECHELON 10 MICROCATHETER (EV3, (B)(4)), TRAXCESS 0.014" MICRO GUIDEWIRE (MICROVENTION, (B)(4)), RADIOFOCUS 0.012" GT MICRO GUIDEWIRE (TERUMO), TRANSFORM BALLOON (STRYKER NEUROVASCULAR, (B)(4)), TARGET COIL (STRYKER NEUROVASCULAR), AND HYDROSOFT HYDROCOIL (MICROVENTION). UDI: THE PRODUCT NUMBER AND LOT WERE NOT PROVIDED. UDI UNKNOWN. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE MANUFACTURE DATE AND EXPIRATION DATE OF THE DEVICE WAS UNKNOWN. THE DATE OF THE EVENT WAS UNKNOWN. LITERATURE ARTICLE ATTACHED TO THIS REPORT: SHOTAR, E. BRUNO L, FLORE, B ET. AL. (2016). NON-ISCHEMIC CEREBRAL ENHANCING LESIONS SECONDARY TO ENDOVASCULAR ANEURYSM THERAPY: NICKEL ALLERGY OR FOREIGN BODY REACTION? CASE SERIES AND REVIEW OF THE LITERATURE, NEURORADIOLOGY, DOI 10.1007/S00234-016-1699-5. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE ARTICLE AUTHOR; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. CONCLUSION: IN THE CONFERENCE ABSTRACT FOUND IN A LITERATURE SEARCH ¿NON-ISCHEMIC CEREBRAL ENHANCING LESIONS SECONDARY TO ENDOVASCULAR ANEURYSM THERAPY: NICKEL ALLERGY OR FOREIGN BODY REACTION? CASE SERIES AND REVIEW OF THE LITERATURE¿ BY SHOTAR , EIMAD, BRUNO LAW-YE, FLORE BARONNET-CHAUVET, SINEAD ZEIDAN, DIMITRI PSIMARAS, FRANCK BIELLE, CATHERINE PECQUET SOLEDAD NAVARRO, CHARLOTTE ROSSO, FLEUR COHEN, JACQUES CHIRAS, FEDERICO DI MARIA, NADER SOUROUR, FRÉDÉRIC CLARENÇON, PUBLISHED NEURORADIOLOGY, DOI 10.1007/S00234-016-1699-5, IT WAS REPORTED THAT ONE PATIENT HAD NICE (NON-ISCHEMIC CEREBRAL ENHANCING LESIONS) OCCUR APPROXIMATELY 4 WEEKS POST EMBOLIC COIL EMBOLIZATION WAS PERFORMED USING A CODMAN 6F ENVOY CATHETER (CATALOG AND LOT NUMBERS NOT PROVIDED) AND OTHER CODMAN COMPETITOR DEVICES. PER THE ARTICLE: ¿A (B)(6) MALE PATIENT WITH MEDICAL HISTORY OF PENICILLIN ALLERGY HAD PRESENTED WITH A RUPTURED 4-MM ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. WITHIN 24 HOURS, ENDOVASCULAR THERAPY (EVT) WAS PERFORMED BY MEANS OF A RIGHT TRANSFEMORAL APPROACH, LEFT INTERNAL CAROTID ARTERY (ICA) CATHETERIZATION, AND BALLOON-ASSISTED ANEURYSM COILING. THE PROCEDURE WAS UNEVENTFUL. ON DAY 28, THE PATIENT PRESENTED WITH PROGRESSIVE ONSET OF RIGHT-SIDED HYPOESTHESIA AND HEADACHE. A CT SCAN ON DAY 32 SHOWED MULTIFOCAL LEFT FRONTAL AND PARIETAL HYPODENSITIES. MRI SHOWED MULTIPLE LEPTOMENINGEAL, CORTICAL AND SUBCORTICAL MICRONODULAR AND ANNULAR ENHANCING LESIONS, AND HYPERINTENSE PERI-LESION EDEMA WITH VASCULAR DISTRIBUTION IN THE TERRITORIES OF THE RIGHT ANTERIOR CEREBRAL ARTERY, LEFT ANTERIOR CEREBRAL ARTERY AND LEFT MIDDLE CEREBRAL ARTERY, SUGGESTIVE OF NICE LESIONS. SERUM AND CEREBROSPINAL FLUID ANALYSES WERE ALL NEGATIVE FOR INFECTION. THE EDEMA SIGNIFICANTLY INCREASED AND SYMPTOMS WORSENED WITHIN THE NEXT 10 DAYS WITH ONSET OF SPEECH DISTURBANCE, RIGHT ARM WEAKNESS, AND SEIZURE. THE ENVOY CATHETER WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. BRAIN EDEMA, BRAIN LESIONS, ALLERGY OR FOREIGN BODY REACTION ARE NOT LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A POSSIBLE COMPLICATION OF USE FOR THE ENVOY CATHETER. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THIS EVENT. SINCE THE AUTHOR DID NOT SPECIFICALLY ATTRIBUTE THE EVENT TO THE ENVOY CATHETER, THE EVENT MAY HAVE BEEN RELATED TO THE MULTIPLE OTHER DEVICES USED IN THE PROCEDURE, INCLUDING RADIOFOCUS 0.035" HYDROPHILIC GUIDEWIRE (TERUMO, (B)(4)), ECHELON 10 MICROCATHETER (EV3, (B)(4)), TRAXCESS 0.014" MICRO GUIDEWIRE (MICROVENTION, (B)(4)), RADIOFOCUS 0.012" GT MICRO GUIDEWIRE (TERUMO), TRANSFORM BALLOON (STRYKER NEUROVASCULAR, (B)(4)), TARGET COIL (STRYKER NEURYOVASCULAR), AND HYDROSOFT HYDROCOIL (MICROVENTION). SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN THE CONFERENCE ABSTRACT FOUND IN A LITERATURE SEARCH ¿NON-ISCHEMIC CEREBRAL ENHANCING LESIONS SECONDARY TO ENDOVASCULAR ANEURYSM THERAPY: NICKEL ALLERGY OR FOREIGN BODY REACTION? CASE SERIES AND REVIEW OF THE LITERATURE¿ BY SHOTAR , EIMAD, BRUNO LAW-YE, FLORE BARONNET-CHAUVET, SINEAD ZEIDAN, DIMITRI PSIMARAS, FRANCK BIELLE, CATHERINE PECQUET SOLEDAD NAVARRO, CHARLOTTE ROSSO, FLEUR COHEN, JACQUES CHIRAS, FEDERICO DI MARIA, NADER SOUROUR, FRÉDÉRIC CLARENÇON, PUBLISHED NEURORADIOLOGY, DOI 10.1007/S00234-016-1699-5, IT WAS REPORTED THAT ONE PATIENT HAD NICE (NON-ISCHEMIC CEREBRAL ENHANCING LESIONS) OCCUR APPROXIMATELY 4 WEEKS POST EMBOLIC COIL EMBOLIZATION WAS PERFORMED USING A CODMAN 6F ENVOY CATHETER (CATALOG AND LOT NUMBERS NOT PROVIDED) AND OTHER CODMAN COMPETITOR DEVICES. PER THE ARTICLE: ¿A (B)(6) MALE PATIENT WITH MEDICAL HISTORY OF PENICILLIN ALLERGY HAD PRESENTED WITH A RUPTURED 4-MM ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. WITHIN 24 HOURS, ENDOVASCULAR THERAPY (EVT) WAS PERFORMED BY MEANS OF A RIGHT TRANSFEMORAL APPROACH, LEFT INTERNAL CAROTID ARTERY (ICA) CATHETERIZATION, AND BALLOON-ASSISTED ANEURYSM COILING. THE PROCEDURE WAS UNEVENTFUL. ON DAY 28, THE PATIENT PRESENTED WITH PROGRESSIVE ONSET OF RIGHT-SIDED HYPOESTHESIA AND HEADACHE. A CT SCAN ON DAY 32 SHOWED MULTIFOCAL LEFT FRONTAL AND PARIETAL HYPODENSITIES. MRI SHOWED MULTIPLE LEPTOMENINGEAL, CORTICAL AND SUBCORTICAL MICRONODULAR AND ANNULAR ENHANCING LESIONS, AND HYPERINTENSE PERI-LESION EDEMA WITH VASCULAR DISTRIBUTION IN THE TERRITORIES OF THE RIGHT ANTERIOR CEREBRAL ARTERY, LEFT ANTERIOR CEREBRAL ARTERY AND LEFT MIDDLE CEREBRAL ARTERY, SUGGESTIVE OF NICE LESIONS. SERUM AND CEREBROSPINAL FLUID ANALYSES WERE ALL NEGATIVE FOR INFECTION. THE EDEMA SIGNIFICANTLY INCREASED AND SYMPTOMS WORSENED WITHIN THE NEXT 10 DAYS WITH ONSET OF SPEECH DISTURBANCE, RIGHT ARM WEAKNESS, AND SEIZURE. CORTICOSTEROID TREATMENT WAS STARTED (1 G/DAY OF INTRAVENOUS METHYLPREDNISOLONE FOR 7 DAYS), FOLLOWED BY RAPID REGRESSION OF THE NICE LESIONS AND THE PERIPHERAL EDEMA AND THE RESOLUTION OF THE SYMPTOMS. FIVE MONTHS AFTER EVT, THE PATIENT WAS ASYMPTOMATIC AND THE FOLLOW-UP MRI SHOWED ONLY SLIGHT RESIDUAL NICE LESIONS AND EDEMA. TEN MONTHS AFTER EVT, THE PATIENT PRESENTED WITH RECURRENT HYPOESTHESIA. MRI DEMONSTRATED INCREASED NICE LESIONS AND PERILESIONAL EDEMA. CORTICOSTEROID TREATMENT WAS STARTED (1 G/DAY OF INTRAVENOUS METHYLPREDNISOLONE FOR 5 DAYS) AND THE PATIENT RECOVERED. SKIN PATCH TESTING WITH NICKEL AND ALL THE ENDOVASCULAR DEVICES SIMILAR TO THOSE USED DURING THE ORIGINAL PROCEDURE WAS FOUND TO BE UNREACTIVE. THE RETROSPECTIVE REVIEW OF ALL PATIENTS MANAGED BY EVT AT A SINGLE INSTITUTION BETWEEN JANUARY 1, 2012 TO DECEMBER 31,2014 FOUND 2 PATIENTS OUT OF 374 (0.5) WHICH DEMONSTRATED NICE LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525645 UNKNOWN ENVOY 6F INTRAVASCULAR GUIDING CATHETER DQY CODMAN AND SHURTLEFF, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention