BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED JR.

    MDR report key: 17495182 · Received August 9, 2023

    Report

    Report Number
    2032493-2023-00889
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    July 17, 2023
    Report Date
    July 25, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    0081236020709
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THREE RADIOGRAPHIC IMAGES WERE PROVIDED FOR REVIEW. THEY ARE NOT LABELED AS TO TIME OR DATE, SO THEIR CHRONOLOGICAL ORDER COULD NOT BE DETERMINED. THE REVIEW OF THE IMAGES IS AS FOLLOWS: IMAGE1: LEFT VERTEBRAL DSA, AP, SUBTRACTED. THE SUBTRACTION ARTIFACT OF TWO STENTS IN THE RIGHT P2 SEGMENT OF THE RIGHT PCA CAN BE OBSERVED. THERE ARE COILS IN A SUPERIORLY DIRECTED PROXIMAL P2 ANEURYSM; THE STENT, P1, AND P2 SEGMENTS ARE OCCLUDED. THERE MAY BE A BIT OF CONTRAST IN THE MEDIAL UPPER PART OF THE ANEURYSM, ADJACENT TO THE COILS. THE RIGHT SCA IS DUPLICATED WITH DECREASED FLOW IN THE MORE DISTAL DUPLICATED SCA. WITHOUT HAVING A PRE-PROCEDURE ANGIOGRAM, IT CANNOT BE DETERMINED IF THERE IS DUPLICATION OF THE RIGHT SCA AND AN OCCLUDED RIGHT PCA, OR A SINGLE RIGHT SCA AND A PARTIALLY PATENT RIGHT PCA. IMAGE2: AP UNSUBTRACTED RADIOGRAPH, NO CONTRAST. A DAC¿S DISTAL TIP IS IN THE MID PORTION OF THE STENT CONSTRUCT. IMAGE3: AP UNSUBTRACTED RADIOGRAPH, NO CONTRAST. A DAC IS SEEN IN THE DISTAL BASILAR. AN INFLATED MICRO BALLOON IS SEEN FROM THE PROXIMAL STENT CONSTRUCT ALMOST TO ITS DISTAL END. THESE IMAGES DO NOT EXPLAIN WHY THE STENT CONSTRUCT CLOTTED. WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION IS UNABLE TO DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: 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 DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. COMPLAINT SYSTEM REVIEW: BASED ON A REVIEW OF THE LAST 2 YEARS OF COMPLAINT DATA, AND AT THE TIME OF THIS INVESTIGATION, NO SYSTEMIC ISSUES HAVE BEEN IDENTIFIED FOR THIS BATCH NUMBER THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU): POTENTIAL COMPLICATIONS POSSIBLE COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: ¿ BLEEDING OR HEMORRHAGE INCLUDING INTRACEREBRAL, RETROPERITONEAL OR OTHER LOCATIONS ¿ COMPLICATIONS OF ARTERIAL PUNCTURE INCLUDING PAIN, LOCAL BLEEDING (HEMATOMA) OR INJURY TO THE ARTERY OR ADJACENT NERVES ¿ DEVICE MIGRATION ¿ DISTAL EMBOLIZATION ¿ HEADACHE ¿ INCOMPLETE ANEURYSM OCCLUSION ¿ NEUROLOGIC DEFICITS INCLUDING STROKE AND/OR DEATH ¿ PERFORATION OR DISSECTION OF THE VESSEL(S) ¿ PSEUDOANEURYSM FORMATION ¿ RUPTURE OR PERFORATION OF ANEURYSM ¿ TRANSIENT ISCHEMIC ATTACK (TIA) OR ISCHEMIC STROKE ¿ VASOSPASM ¿ VESSEL OCCLUSION ¿ VESSEL STENOSIS OR THROMBOSIS WARNINGS SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING ACCESS OR REMOVAL, THE INTRODUCER/GUIDE CATHETER/MICROCATHETER AND FRED JR. SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE DURING DELIVERY OR RETRIEVAL OF THE FRED JR. SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE DEVICE AND DELIVERY COMPONENTS. IT IS IMPERATIVE TO USE THE FRED JR. SYSTEM WITH A HEADWAY® 21 MICROCATHETER. IF REPEATED FRICTION IS ENCOUNTERED DURING FRED JR. SYSTEM DELIVERY, VERIFY MICROCATHETER IS NOT KINKED OR IN EXTREMELY TORTUOUS ANATOMY. CONFIRM THAT THE MICROCATHETER DOES NOT OVALIZE. CONFIRM THAT THERE IS ADEQUATE STERILE HEPARINIZED FLUSH SOLUTION. DO NOT REPOSITION THE FRED JR. SYSTEM IN THE PARENT VESSEL WITHOUT FULLY RETRIEVING THE DEVICE. THE FRED JR. SYSTEM MUST BE RETRIEVED/RESHEATHED INTO THE MICROCATHETER AND RE-DEPLOYED AT THE DESIRED TARGET LOCATION OR REMOVED COMPLETELY FROM THE PATIENT. CAUTIONS EXERCISE CAUTION WHEN CROSSING THE DEPLOYED/DETACHED FRED JR. SYSTEM WITH ADJUNCTIVE DEVICES SUCH AS GUIDEWIRES, CATHETERS, MICROCATHETERS OR BALLOON CATHETERS TO AVOID DISRUPTING THE DEVICE GEOMETRY AND DEVICE PLACEMENT. DIRECTIONS FOR USE 12. ADVANCE THE DELIVERY WIRE TO TRANSFER THE FRED JR. SYSTEM FROM WITHIN THE INTRODUCER INTO THE MICROCATHETER. WARNING: DO NOT TORQUE THE DELIVERY WIRE WHILE ADVANCING OR RETRACTING THE FRED JR. SYSTEM. 13. CONTINUE ADVANCING THE DELIVERY WIRE INTO THE MICROCATHETER UNTIL THE PROXIMAL TIP OF THE DELIVERY WIRE ENTERS THE INTRODUCER. LOOSEN THE RHV LOCKING RING, REMOVE THE INTRODUCER, AND SET IT ASIDE. WARNING: DO NOT APPLY UNDUE FORCE. IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING DELIVERY OR MANIPULATION, WITHDRAW THE UNIT AND SELECT A NEW FRED JR. SYSTEM. 15. POSITION THE FRED JR. SYSTEM FOR DEPLOYMENT BY ALIGNING THE FRED JR. SYSTEM IMPLANT DISTAL RADIOPAQUE END MARKERS APPROXIMATELY 3 MM PAST THE ANEURYSM NECK OR APPROXIMATELY HALF THE WIDTH OF THE NECK PAST THE NECK FOR LARGER ANEURYSMS. [FIGURE 7] NOTE: A SLOW, PROPER PUSH/PULL TECHNIQUE, ENCOMPASSING SUFFICIENT DELIVERY WIRE PUSH FORCE, IN ADDITION TO AN OPPOSING MICROCATHETER WITHDRAWAL FORCE, TO REMOVE EXCESS MICROCATHETER SLACK WHILE MAINTAINING THE MICROCATHETER TIP WITHIN THE CENTER OF THE PARENT VESSEL, WILL FACILITATE PROPERLY DEPLOYING THE FRED JR. SYSTEM AT THE PROPER LOCATION, TO ACHIEVE FULL EXPANSION AND GOOD VESSEL APPOSITION. CAUTION: USING A RAPID MICROCATHETER WITHDRAWAL TECHNIQUE TO DEPLOY THE FRED JR. SYSTEM IS NOT RECOMMENDED AND MAY RESULT IN DEVICE ELONGATION OR IMPROPER DEPLOYMENT. BE AWARE OF DELIVERY WIRE TIP POSITION DURING DEPLOYMENT. 16. IF FRED JR. SYSTEM POSITIONING IS NOT SATISFACTORY, THE IMPLANT MAY BE RECAPTURED AND REPOSITIONED IF IT IS NOT FULLY DEPLOYED. THE IMPLANT MAY BE RECAPTURED UNTIL THE POINT WHERE THE DISTAL-MOST WIRE MARKER, COLLOCATED DISTAL TO THE IMPLANT PROXIMAL MARKERS, IS ALIGNED APPROXIMATELY 50% OF LENGTH PROXIMAL TO THE MICROCATHETER DISTAL MARKER BAND. [FIGURE 8] CAUTION: IF RESISTANCE IS FELT WHILE RECAPTURING THE DEVICE, DO NOT CONTINUE TO RECAPTURE. WITHDRAW THE MICROCATHETER SLIGHTLY TO UNSHEATH THE DEVICE (WITHOUT EXCEEDING THE RECAPTURE LIMIT), AND THEN ATTEMPT TO RECAPTURE AGAIN. CAUTION: THE FRED JR. SYSTEM MUST NOT BE RE-DEPLOYED MORE THAN THREE TIMES. CAUTION: THE FRED JR. SYSTEM DELIVERY WIRE SHOULD NOT BE UTILIZED AS A GUIDEWIRE. DO NOT TORQUE THE FRED JR. SYSTEM. A TORQUE DEVICE SHOULD NOT BE USED. 17. IF FRED JR. SYSTEM POSITIONING IS SATISFACTORY, CAREFULLY ADVANCE THE DELIVERY WIRE WHILE RETRACTING THE MICROCATHETER AS NEEDED TO MINIMIZE SLACK, MAINTAINING THE MICROCATHETER AROUND THE CENTER OF THE PARENT VESSEL, TO ALLOW THE IMPLANT TO DEPLOY ACROSS THE NECK OF THE ANEURYSM. ENSURE THE IMPLANT PROXIMAL RADIOPAQUE END MARKERS ARE APPROXIMATELY 3 MM OR APPROXIMATELY HALF THE WIDTH OF THE NECK PROXIMAL TO THE ANEURYSM NECK FOR ADEQUATE COVERAGE. NOTE: THE FRED JR. SYSTEM WILL EXPAND AND MAY FORESHORTEN UP TO 50% FROM ITS UNDEPLOYED LENGTH. VISUALLY VERIFY OPENING OF THE PROXIMAL END, ENSURING THAT THE MICROCATHETER DISTAL TIP MARKER IS PULLED BACK, ADEQUATELY AWAY FROM THE IMPLANT PROXIMAL END, TO ALLOW THE PROXIMAL END TO FREELY OPEN. NOTE: VISUALIZE AND REFER TO IMPLANT RADIOPAQUE END MARKERS TO MAINTAIN ADEQUATE IMPLANT LENGTH OF APPROXIMATELY 3 MM OR APPROXIMATELY HALF THE WIDTH OF THE NECK ON EACH SIDE OF THE ANEURYSM NECK/TARGET LOCATION TO ENSURE APPROPRIATE COVERAGE. [FIGURE 7] WARNING: DO NOT DETACH THE FRED JR. SYSTEM IF IT IS NOT PROPERLY POSITIONED IN THE PARENT VESSEL. WARNING: IF APPLICABLE, OBSERVE FRED JR. SYSTEM MARKER POSITION DURING COILING PROCEDURE TO ENSURE THAT THE DEVICE DOES NOT MIGRATE. 19. CAREFULLY INSPECT THE DEPLOYED FRED JR. IMPLANT UNDER FLUOROSCOPY TO CONFIRM THAT IT IS COMPLETELY APPOSED TO THE VESSEL WALL AND NOT KINKED. IF THE IMPLANT IS NOT FULLY APPOSED OR IS KINKED, CONSIDER UTILIZING A SUITABLE MICROGUIDEWIRE AND/OR OCCLUSION BALLOON CATHETER TO FULLY OPEN THE IMPLANT. 20. VERIFY THAT THE IMPLANT REMAINS PATENT AND PROPERLY POSITIONED. NOTE: THE JAILED MICROCATHETER SHOULD BE CAREFULLY REMOVED TO AVOID DISLODGING THE FRED JR. IMPLANT. 21. CAUTION: CAREFULLY WATCH THE FRED JR. IMPLANT DISTAL AND PROXIMAL MARKERS WHEN PASSING THROUGH THE IMPLANTED DEVICE WITH OTHER DEVICES TO AVOID DISPLACING THE IMPLANT. INVESTIGATION CONCLUSION THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO EVENT. SUPPLEMENTAL IMAGING WAS ALSO UNAVAILABLE FOR REVIEW; WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION DEFINITIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT. THIS INFORMATION MAY BE UPDATED IF ADDITIONAL INFORMATION IS PROVIDED AT A LATER DATE.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS AND PROCEDURE IMAGES WERE NOT PROVIDED. THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A BLISTERING ANEURYSM IN RIGHT P2 SEGMENT OF THE POSTERIOR CEREBRAL ARTERY (PCA) WAS PREVIOUSLY TREATED, BEFORE AND AFTER 2005, WITH COILS AND STENTS OF UNSPECIFIED BRAND. THE FLOW DIVERTER FRED JR. STENT WAS SUCCESSFULLY IMPLANTED IN THE PATIENT TO TREAT A RECURRENCE OF THE RIGHT P2 ANEURYSM. THIS WAS THE FIRST FLOW DIVERTER USED IN THE PATIENT. ANTICOAGULATION WAS STILL THE SAME SINCE MONTHS AGO. THE INTERVENTION HAS BEEN SUCCESSFUL AND THE CONTROL POST PROCEDURE WAS GOOD. REPORTEDLY, FOUR DAYS POST IMPLANTATION, THE STENT COMPLETELY OCCLUDED. A THROMBECTOMY WAS ATTEMPTED TO RE-CANALIZE BUT WAS UNSUCCESSFUL. AT THE OUTCOME THE STENT REMAINED OCCLUDED AND THE PATIENT HAD HEMIPARESIS AND NIH: 11. THE PATIENT IS CURRENTLY IN REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892122 FRED JR. INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICROVENTION, INC. FREDJR2513 0000283358 0081236020709

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention