BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2873610 · Received December 14, 2012

    Report

    Report Number
    2029214-2012-00716
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    June 21, 2011
    Report Date
    November 20, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SAME EVENT AS MDR# 2029214-2013-00858. (B)(4) FOLLOW-UP 2.

    Additional Manufacturer Narrative · 1

    UPDATING MDR WITH ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. FOR THE PROCEDURE ON (B)(6) 2011, THE INFORMATION ON THE TWO PIPELINES IMPLANTED ARE MODEL# FA-77475-20 / LOT# NOT REPORTED AND MODEL# FA-77500-20 / LOT# 9430562. PROCEDURE ANGIOGRAPHY OF LEFT ICA: (B)(6) YEAR PATIENT WITH LEFT SIDE LARGE CAVERNOUS SINUS ANEURYSM, WHO DEVELOPED 6TH CRANIAL NERVE PALSY. SHE WAS PREVIOUSLY AWARE OF ANEURYSM AND WAS UNDER OBSERVATION. FEMORAL ARTERY WAS PUNCTURED WITH 19 GAUGE NEEDLE. A 0.038 WIRE ADVANCED. NEEDLE WAS REMOVED AND A 8 FRENCH SHEATH WAS ADVANCED. THEN A 6 FRENCH WAS NAVIGATED FROM THE GROIN. ANGIOGRAM IN THE FEMORAL ARTERY DEMONSTRATED SIGNIFICANT ATHEROSCLEROTIC DISEASE AND CHRONIC FLOW LIMITATION IN ONE OF THE BRANCHES OF THE FEMORAL ARTERY. 2 PED WERE USED TO TREAT THE LARGE CAVERNOUS SINUS ANEURYSM. SIGNIFICANT STASIS WITHIN THE ANEURYSM. NO COMPLICATIONS FOR THE PROCEDURE ON (B)(6) 2011, THE INFORMATION FOR THE PIPELINE IMPLANTED IS MODEL# FA-77500-18 / LOT# 9431038 (QTY. 2). IT WAS A TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 17MM X 10MM LOCATED IN THE CAVERNOUS SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). PATIENT SYMPTOMS: FULL BLOWN LEFT CAVERNOUS SINUS SYNDROME WITH COMPROMISE OF 3RD, 4TH, 6TH AND 1ST DIVISION OF THE TRIGEMINAL NERVE. FIRST PIPELINE 5X18 DEPLOYED RIGHT ACROSS THE NECK OF THE ANEURYSM, CAUSING A SMALL AMOUNT OF STASIS. THEN WE CAPTURED THE FIRST WIRE AND DEPLOYED A SECOND STENT 5X18 WITHOUT COMPLICATIONS. WE PERFORMED A 3-D ANGIORGRAPHY AFTERWARDS TO VERIFY THE OPPOSITION OF THE STENT. THERE WAS A SMALL AREA OF STRICTURE. WE PERFORMED BALLOON ANGIOPLASTY. ON (B)(6) 2011, THE PATIENT EXPERIENCED AN INTRAPARENCHYMAL HEMORRHAGE. SEVERITY: MODERATE PATIENT BECAME LETHARGIC, HEMIPARETIC ON THE LEFT SIDE AND RESOLVED ON (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A CAVERNOUS (CAV) ANEURYSM. IT WAS REPORTED THAT A TOTAL OF TWO PIPELINES WERE IMPLANTED, BUT THE SECOND PIPELINE NEEDED BALLOON ANGIOPLASTY TO ACHIEVE FULL WALL APPOSITION (WHICH IS AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE). IT WAS REPORTED THAT THE PATIENT HAD AN INTRACRANIAL HEMORRHAGE, LEFT MIDDLE CEREBRAL ARTERY (MCA) INFARCTS, AND NO REACTION IN THE LEFT PUPIL ALL OF WHICH WAS RESOLVED ON (B)(6) 2012. UPDATED INFORMATION ON (B)(6) 2012: PATIENT WAS FOUND TO HAVE A LEFT CRANIAL NERVE3, 4, 6 PALSY RESULTING IN A FROZEN GLOBE AS WELL AS SOME EYE PAIN. SHE REMAINED ON AAOX3 AND FULL STRENGTH IN EXT. STARTED ON STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-18 (QTY 2) 9431038 (QTY 2)

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention| S