BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 16686637 · Received April 5, 2023

    Report

    Report Number
    2032493-2023-00649
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    March 16, 2023
    Report Date
    March 17, 2023
    Manufacturer
    MICROVENTION, INC
    Product Code
    OPR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A SEARCH FOR PRODUCTION-RELATED NCRS COULD NOT BE PERFORMED. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN AND INVESTIGATION. IF THE DEVICE IS RECEIVED LATER, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES STROKE AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    PROCEDURE NOTE MEDICAL REVIEW, PROCEDURE NOTE MEDICAL REVIEW FOR COMPLAINT (B)(4). A DETAILED PROCEDURE NOTE MEDICAL REVIEW HAS BEEN PERFORMED FOR COMPLAINT (B)(4). DATA REVIEW INDICATES TREATMENT WAS PERFORMED FOR AN IRREGULAR ANTERIOR COMMUNICATING ARTERY ANEURYSM USING STENT ASSISTED COIL EMBOLIZATION AND WEB EMBOLIZATION. DATA REVIEW INDICATES THAT A 5MM X 3 MM WEB SL DEVICE WAS UNSHEATHED WITHIN THE ANEURYSM, DUE TO THE ANEURYSM ORIENTATION AND ANGULATION THE DESIRED POSITION OF THE DEVICE COULD NOT BE OBTAINED. WEB DEVICE, VIA AND SOPHIA DEVICES WERE THUS REMOVED. PROCEDURE WAS COMPLETED USING STENT ASSISTED COILING. PROCEDURE NOTE MEDICAL REVIEW CONCLUSION FOR COMPLAINT (B)(4) A DETAILED PROCEDURE NOTE MEDICAL REVIEW HAS BEEN COMPLETED FOR COMPLAINT (B)(4). WEB DEVICE WAS SUCCESSFULLY UNSHEATHED IN THE ANEURYSM, BUT THE PHYSICIAN WAS UNABLE TO BE DEPLOY THE DEVICE IN A SATISFACTORY POSITION DUE TO THE ORIENTATION AND ANGULATION OF THE PATIENT¿S ANEURYSM. NO DEVICE MALFUNCTION WAS REPORTED FOR THE WEB DEVICE. SURGICAL REMOVAL OF THE DEVICE WAS BASED SOLELY ON THE ANEURYSM ORIENTATION AND ANGULATION. ITEMS RETURNED: N/A. VISUAL ANALYSIS: A VISUAL INSPECTION OF THE DEVICE CAPTURED IN THIS FILE COULD NOT BE PERFORMED AS A PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION, NOR WERE ANY IMAGES OF THE DEVICE PROVIDED IN PLACE OF A DEVICE RETURN. PROCEDURE AND MEDICAL IMAGING WAS NOT PROVIDED FOR THIS INVESTIGATION. INVESTIGATION FINDINGS: WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT DEFINITIVELY DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION DEFINITIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT. BASED ON A REVIEW OF THE DEVICE¿S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THERE WERE ANY POTENTIAL OR NEW MANUFACTURING, DESIGN, QUALITY, OR OTHER SYSTEMIC ISSUES, OR NON-CONFORMANCES. THE COMPLAINT CODE IS MONITORED THROUGH THE TRENDING PROCESS; CORRECTIVE ACTION IS DETERMINED, AS NEEDED, THROUGH THIS PROCESS. INVESTIGATIONS OF HISTORIC COMPLAINT FILES WITH SIMILAR COMPLAINT CATEGORY CODING ARE RECORDED IN THE COMPLAINT HANDLING SYSTEM; WITHOUT THE ABILITY TO PERFORM AND ANALYSIS OF THE DEVICE, THIS INVESTIGATION CANNOT IDENTIFY WITH CERTAINTY ANY POTENTIAL ROOT CAUSES. BATCH REVIEW: A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION COULD NOT BE PERFORMED AS THIS INFORMATION WAS NOT AVAILABLE AT THE TIME THIS INVESTIGATION WAS PERFORMED. COMPLAINT SYSTEM REVIEW: A SEARCH OF THE COMPLAINT HANDLING SYSTEM COULD NOT BE PERFORMED TO DETERMINE IF OTHER SIMILAR COMPLAINTS EXIST FOR THIS BATCH NUMBER, BECAUSE THE BATCH NUMBER WAS NOT PROVIDED FOR THE PRODUCT ON THIS COMPLAINT FILE. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU): POTENTIAL COMPLICATIONS POTENTIAL COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: VESSEL PUNCTURE SITE HEMATOMA, ANEURYSM PERFORATION OR RUPTURE, HEMORRHAGE, EDEMA, THROMBOEMBOLI, TRANSIENT ISCHEMIC ATTACK, ISCHEMIC STROKE, NEUROLOGIC DEFICITS, PARENT ARTERY OCCLUSION, ISCHEMIA, VESSEL DISSECTION OR PERFORATION, VASCULAR THROMBOSIS, VASOSPASM, DEVICE MIGRATION OR MISPLACEMENT, PREMATURE DETACHMENT, HEADACHE, POST-EMBOLIZATION SYNDROME, INFECTION AND DEATH. THE WEB EMBOLIZATION DEVICE REQUIRES THE USE OF FLUOROSCOPY. POTENTIAL COMPLICATIONS RELATED TO ANGIOGRAPHIC AND FLUOROSCOPIC RADIATION DOSES INCLUDE, BUT ARE NOT LIMITED TO, ALOPECIA, BURNS RANGING IN SEVERITY FROM SKIN REDDENING TO ULCERS, CATARACTS, AND DELAYED NEOPLASIA. THE PROBABILITY OF OCCURRENCE OF COMPLICATIONS MAY INCREASE AS PROCEDURE TIME AND NUMBER OF PROCEDURES INCREASE. OTHER PROCEDURAL COMPLICATIONS INCLUDING BUT NOT LIMITED TO ANESTHETIC AND CONTRAST MEDIA RISKS, HYPOTENSION, HYPERTENSION AND ACCESS SITE COMPLICATIONS. WEB EMBOLIZATION DEVICE SIZE SELECTION 7. THE WEB IMPLANT SHOULD BE DEPLOYED USING DEVICE DIAMETER OVER-SIZING RELATIVE TO THE DIAMETER OF THE TARGET LESION. SEE THE WARNINGS SECTION FOR ADDITIONAL INFORMATION FOR THE SAFE DEPLOYMENT OF THE WEB EMBOLIZATION DEVICE. 8. UNDERSTAND THE ANEURYSM SHAPE, WIDTH AND HEIGHT BY PERFORMING 2D-ANGIOGRAPHIC FLUOROSCOPY IN TWO ORTHOGONAL PROJECTIONS. 9. MEASURE THE ANEURYSM NECKS, DIAMETERS, AND HEIGHTS OF THE ANEURYSM IN EACH PROJECTION.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE CLINICAL WEB POST APPROVAL STUDY, THE PHYSICIAN WAS UNABLE TO PLACE THE WEB DEVICE. IT WOULD NOT STAY IN A SATISFACTORY LOCATION AND THE DEVICE DID NOT DETACH. THEREFORE, HE TRANSITIONED TO USING A DIFFERENT TREATMENT METHOD. THE PATIENT HAD APHASIA AND SLIGHT RIGHT-SIDED WEAKNESS POST TREATMENT AND THE ADVERSE EVENT IS ATTRIBUTED TO THE DEVICE AND PROCEDURE. THE PATIENT IS SCHEDULED TO BE EVALUATED AT THE 30-DAY FOLLOW-UP. NO INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869190 UNKNOWN INTRASACCULAR DEVICES OPR MICROVENTION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other