BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 8769324 · Received July 8, 2019

    Report

    Report Number
    2029214-2019-00694
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 8, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REPORTED EVENTS ARE KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A POST PROCEDURE AND PATIENT CONDITION RELATED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THROUGH LITERATURE REVIEW OF ¿LONG-TERM VISUAL OUTCOME IN PATIENTS TREATED BY FLOW DIVERSION FOR CAROTID-OPHTHALMIC ANEURYSMS¿ (ROMAIN TOUZÉ, VALÉRIE TOUITOU, EIMAD SHOTAR, JOSEPH GABRIELI, MEHDI DRIR, BERTRAND MATHON, NADER-ANTOINE SOUROUR, FRÉDÉRIC CLARENÇON) IN 68.8% OF THE CASES (11/16), FDSS USED WERE PIPELINE EMBOLIZATION DEVICES. LONG-TERM OPHTHALMIC OUTCOME: AMONG THE 15 PATIENTS WITH 16 CAROTID-OPHTHALMIC ANEURYSMS (COAS) REVIEWED WITH FULL OPHTHALMIC EXAMINATION WITH AN AVERAGE FOLLOW-UP OF 4.14±2.03 YEARS, OPHTHALMIC ABNORMALITIES WERE DEPICTED IN 37.5% (6/16) ANEURYSMS AND 40% (6/15) PATIENTS. WE FOUND THREE CASES OF AMAUROSIS FUGAX ON THE SIDE OF THE STENT (18.8%). ONE AMAUROSIS FUGAX OCCURRED AFTER THE PROCEDURE WITHOUT ANY RECURRENCE, TWO AFTER STOPPING OF THE ANTIPLATELET THERAPY, 6 MONTHS (AFTER REMOVAL OF THE DUAL ANTIPLATELET AND ONLY WITH ASPIRIN) AND 13 MONTHS (AFTER REMOVAL OF THE ASPIRIN ONLY) AFTER STENTING. MEAN VISUAL ACUITY WERE SIMILAR BETWEEN EYES AND WAS 0.98 IN THE ¿NORMAL SIDE¿ VERSUS 0.97 IN THE ¿FDS SIDE¿. WE FOUND FOUR UNILATERAL VISUAL FIELDS DISTURBANCES WITHOUT COHERENCE OPTIC TOMOGRAPHY (OCT) ABNORMALITIES. ALL VISUAL FIELD¿S MEAN DEVIATIONS (MD) WERE COMPARED BETWEEN THE ¿FDS SIDE¿ AND THE ¿NORMAL SIDE¿. WE FOUND A SIGNIFICANT DIFFERENCE BETWEEN MEAN DEVIATION OF ¿FDS SIDE' VISUAL FIELD AND ¿NORMAL SIDE¿: -1.58±1.12 DB VS -0.67±1.16 DB (P=0.003). THERE WAS THUS A SIGNIFICANT LOSS IN MEAN DEVIATION ON THE ¿FDS SIDE¿. INTERESTINGLY, WE DID NOT OBSERVE ANY DIFFERENCE FOR THE OCCURRENCE OF VISUAL SYMPTOMS IN PATIENTS WITH ADDITIONAL COILING. ANGIOGRAPHIC OUTCOME: THE IMMEDIATE PATENCY OF OPHTHALMIC ARTERY (OA) WAS EVALUATED JUST AFTER THE FDSS IMPLANTATION: WE OBSERVED FIVE SLOW-FLOWS AND TWO OCCLUDED OAS. MEAN ANGIOGRAPHIC FOLLOW-UP WAS 12±7.6 MONTHS. IN THREE CASES (18.8%), OA WAS OCCLUDED AT LAST FOLLOW-UP, WITH RETROGRADE FILLING THROUGH COLLATERALS FROM THE ECA. WE FOUND AN ANEURYSM EXCLUSION (COMPLETE OCCLUSION OR NEAR COMPLETE OCCLUSION) RATE OF 93.7% (15/16 CASES). PROCEDURE-RELATED COMPLICATIONS/CLINICAL OUTCOME: TECHNICAL SUCCESS WAS OBTAINED IN ALL THE CASES. IN 18.8% OF THE CASES, A MALAPPOSITION OF THE FDS PROMPTED THE OPERATOR TO PERFORM AN INTRA-STENT ANGIOPLASTY. AT THE END OF THE PROCEDURES, SATISFACTORY STENT APPOSITION WAS OBSERVED IN 93.7% OF THE CASES. NO MAJOR COMPLICATION FOLLOWING THE TREATMENT WAS RECORDED, NO INTRA-STENT THROMBOSIS, AND NO OCULOMOTOR NERVE PALSY. WE NOTED TWO DELAYED MINOR COMPLICATIONS, AND ONE MINOR THROMBO- EMBOLIC EVENT TOTALLY ASYMPTOMATIC IN THE FLOW-DIVERTER TERRITORY. ONE CASE OF NON-ISCHEMIC CEREBRAL ENHANCING (NICE) LESION WAS RECORDED. ALL PATIENTS REVIEWED HAD A GOOD MODIFIED RANKIN SCALE (0¿2) (MRS) WITH A MEAN CLINICAL FOLLOW-UP OF 4.14 YEARS. IT WAS HYPOTHESIZED TWO PATHOMECHANISMS TO EXPLAIN THESE OPHTHALMIC SYMPTOMS (VISUAL FIELD DEFECTS AND AMAUROSIS FUGAX) AND THE FINDINGS OBSERVED BY THE OPHTHALMIC EXAMINATION. FIRST, AN EMBOLIC CAUSE. THIS MAY BE EXPLAINED BY THE FACT THAT EMBOLI USUALLY DISAPPEAR AFTER A FEW DAYS OF ANTIPLATELET THERAPY, WHILE THE CONSEQUENCES OF THESE DISTAL EMBOLI (SMALL VISUAL FIELD DEFECTS) REMAIN. IN OUR PATIENTS, THE MAIN OPHTHALMIC COMPLICATION OBSERVED WAS THE VISUAL FIELD DEFECT WITH PRESERVED OCT PARAMETERS SUPPORTING AN EFFECT OF FDSS ON VASCULAR AND HEMODYNAMIC OPHTHALMIC SYSTEMS RATHER THAN A COMPRESSIVE MECHANISM DUE TO THE ANEURYSM ITSELF. THE SIGNIFICANT LOSS OF VISUAL FIELD¿S MEAN DEVIATION (MD) IN PATIENTS WITH A FDS COVERING OA, WITHOUT ANY WELL-DEFINED SCOTOMA, TOGETHER WITH NON-ANATOMICALLY DISTRIBUTED VISUAL FIELD DEFECT SUGGEST POSSIBLE PERIPHERAL RETINAL OCCLUSION OR HYPOPERFUSION BY DISTAL EMBOLI. SECOND, A HEMODYNAMIC CAUSE COULD BE PROPOSED TO EXPLAIN OUR FINDINGS. IT WAS HYPOTHESIZED A NON-EFFECTIVE BALANCE BETWEEN ICA AND ECA SUPPLIES TO THE OA AFTER STENT PLACEMENT. FDSS MAY CAUSE A LOW-FLOW IN THE OPHTHALMIC SUPPLY DESPITE COLLATERAL BY THE ECA. OUR STUDY SUPPORTS THE HYPOTHESIS OF A HYPOPERFUSION AS A CAUSE OF VISUAL FIELD DEFICITS IPSILATERAL TO THE FDS. THE EXACT CAUSE OF THE OCCURRENCE OF VISUAL FIELD DEFECTS IN THESE CASES IS NOT CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562562 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other