BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COIL-THERMO MECHANICAL

    MDR report key: 7116544 · Received December 14, 2017

    Report

    Report Number
    2954740-2017-00505
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    October 1, 2017
    Report Date
    November 21, 2017
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    PMA / PMN Number
    K072173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #(B)(4). CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). UNKNOWN PART NUMBER, UDI UNAVAILABLE. THIS COMPLAINT WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: KOMAKI T., HIRAKI T., KANAZAWA S. (2017). BRAIN INFARCTION AFTER EMBOLIZATION OF A PULMONARY ARTERIOVENOUS MALFORMATION WITH METALLIC COILS. DIAGNOSTIC AND INTERVENTIONAL IMAGING. 98 (10), 747-748. HTTP://DX.DOI.ORG/10.1016/J.DIII.2017.02.008. THE ARTICLE WAS PUBLISHED IN OCTOBER 2017. THE EXACT DATE OF PUBLICATION IS UNKNOWN; THEREFORE, THE EVENT DATE IS BEING REPORTED AS (B)(6) 2017. 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. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE NOT AVAILABLE, DEVICE HISTORY RECORD (DHR) REVIEWS COULD NOT BE PERFORMED. PULMONARY ARTERIOVENOUS MALFORMATIONS (PAVM) ARE ABNORMAL DIRECT CONNECTIONS BETWEEN THE PULMONARY ARTERY AND PULMONARY VEIN WHICH RESULT IN A RIGHT-TO-LEFT SHUNT. POTENTIAL COMPLICATIONS INCLUDE STROKE. AS REPORTED IN THE MEDICAL LITERATURE, IF UNTREATED, 33% OF INDIVIDUALS WITH PAVM WILL HAVE A HISTORY OF STROKE AND 18% OF TRANSIENT ISCHEMIC ATTACKS. EMBOLI AND NEUROLOGICAL DEFICIT IS A KNOWN POSSIBLE ADVERSE EVENT ASSOCIATED WITH COIL EMBOLIZATION AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. HOWEVER, THE MICROCOIL DELIVERY SYSTEM IS INTENDED FOR ENDOVASCULAR EMBOLIZATION OF INTRACRANIAL ANEURYSMS. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE EVENT. THE EVENT AS DESCRIBED IN THE ARTICLE WAS MOST LIKELY RELATED TO PATIENT AND PROCEDURAL FACTORS. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEWS OF COMPLAINT HISTORIES FOR THE DEVICE. SINCE THERE IS NO EVIDENCE TO SUGGEST THE EVENT IS RELATED TO A MANUFACTURING 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE LITERATURE PUBLICATION AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 2954740-2017-00503 & 2954740-2017-00505.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE PUBLICATION (KOMAKI T., HIRAKI T., KANAZAWA S. (2017). BRAIN INFARCTION AFTER EMBOLIZATION OF A PULMONARY ARTERIOVENOUS MALFORMATION WITH METALLIC COILS. DIAGNOSTIC AND INTERVENTIONAL IMAGING. 98 (10), 747-748. HTTP://DX.DOI.ORG/10.1016/J.DIII.2017.02.008), THE PATIENT EXPERIENCED DYSARTHRIA AND THROMBOEMBOLISM AFTER IMPLANTATION OF TWO BARE CASHMERE PLATINUM DETACHABLE COILS (8 X 200 MM AND 7 X 17 MM) AND FIVE DETACH-ABLE AZUR HYDROCOILS (THREE OF 3 × 50 MM, ONE OF 6 × 100 MM, AND ONE OF 4 × 50 MM) (TERUMO, TUSTIN, CALIFORNIA, USA) FOR TREATMENT OF A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) IN THE LEFT INFERIOR LINGULAR SEGMENT. EMBOLIZATION OF PAVM WAS PERFORMED UNDER LOCAL ANESTHESIA VIA A RIGHT FEMORAL VEIN UNDER SYSTEMIC HEPARINIZATION WITH 4000 IU OF HEPARIN FOLLOWED BY ADDITIONAL ADMINISTRATION OF 1000 IU PER HOUR. SELECTIVE PULMONARY ARTERIOGRAM IMMEDIATELY AFTER EMBOLIZATION WITH METALLIC COILS DEMONSTRATED A COMPLETE OCCLUSION OF THE LESION. THE PATIENT DID NOT DEVELOP ANY NEUROLOGICAL SYMPTOMS DURING THE PROCEDURE. THE PATIENT WAS INSTRUCTED TO STAY IN BED UNTIL THE NEXT MORNING. ELEVEN HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED UNEXPLAINED DYSARTHRIA, WHICH IMMEDIATELY AND SPONTANEOUSLY IMPROVED. BRAIN ECHO-PLANAR DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING (MRI) 22 HOURS AFTER THE PROCEDURE DEMONSTRATED ¿SHOWER THROMBOEMBOLISM¿. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC, TRANSVENOUS HEPARIN AND EDARAVONE WERE INITIATED. CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) TWO DAYS AFTER THE PROCEDURE SHOWED SHRINKAGE OF THE FEEDING ARTERY AND THE DRAINING VEIN, AS WELL AS COILS IN THE SAC. COIL MIGRATION WAS NOT DEMONSTRATED. REPEATED BRAIN MRI ON DAY FIVE DID NOT DEMONSTRATE ANY NEW INFARCTION. ON DAY NINE, THE PATIENT WAS DISCHARGED WITHOUT ANY SEQUELA. COMPLETE OCCLUSION OF THE LESION WAS CONFIRMED BY PULMONARY ARTERIOGRAPHY AT ONE YEAR. THE PATIENT HAD NO SIGN OR HISTORY SUGGESTIVE OF HEREDITARY HEMORRHAGIC TELANGIAECTASIA (HHT). THE LESION WAS A SIMPLE TYPE, CONSISTING OF A SINGLE FEEDING ARTERY OF 4.0 MM IN DIAMETER, A SINGLE-DRAINING VEIN, AND AN ANEURYSMAL SAC. THE PATIENT DID NOT HAVE COAGULATION DISORDER, CARDIAC DYSRHYTHMIA, OR THROMBUS IN THE LEFT ATRIUM. MRI BEFORE EMBOLIZATION DID NOT SHOW CEREBRAL INFARCTION. OF NOTE, THE PRODUCT CODE AND LOT NUMBERS OF THE CASHMERE COILS WERE NOT PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897839 COIL-THERMO MECHANICAL NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R