BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3525647 · Received December 18, 2013

    Report

    Report Number
    2029214-2013-00992
    Event Type
    Injury
    Date Received
    December 18, 2013
    Report Date
    November 22, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS LIKELY DISCARDED. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: JOURNAL OF CEREBROVASCULAR AND ENDOVASCULAR NEUROSURGERY. 2013 SEPTEMBER, VOLUME 15(NUMBER 3):241-245 "MICROSURGICAL EXTRACTION OF A MALFUNCTIONED PIPELINE EMBOLIZATION DEVICE FOLLOWING COMPLETE DEPLOYMENT." TREATMENT OF A GIANT ANEURYSM LOCATED IN THE MCA (MIDDLE CEREBRAL ARTERY) THAT WAS DETECTED ON A CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) OF THE HEAD. A DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) REVEALED A PARTIALLY THROMBOSED, GIANT RIGHT MCA BIFURCATION WITH A RECANALIZED PORTION MEASURING 11.1 X 7 X 7 MM. THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING ONE PIPELINE (3.25MM X 25MM). DURING THE DEPLOYMENT OF THE PED (PIPELINE EMBOLIZATION DEVICE), ITS PROXIMAL EDGE BECAME PINCHED. BALLOON ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE, U.S.) WAS PERFORMED ON THE PROXIMAL SEGMENT OF THE PIPELINE WITHOUT SUCCESS. A CONTROL ANGIOGRAM IN THE CCA DEMONSTRATED SLOW FLOW THROUGH THE DISTAL RIGHT MCA BRANCHES AND A DECISION WAS MADE TO REMOVE THE PED . SINCE THE DELIVERY WIRE WAS ALREADY REMOVED, IT WAS NO LONGER POSSIBLE TO RETRACT THE PIPELINE. THE MARKSMAN CATHETER WAS THEN REMOVED AND ANGIOGRAM SHOWED LESS DELAY IN THE DISTAL MCA FLOW. THERE WAS NO THROMBUS FORMATION ON THE STENT AND NO EVIDENCE OF THE DISTAL EMBOLI. THE PATIENT WAS THEN TAKEN TO THE INTENSIVE CARE UNIT ON THERAPEUTIC ANTICOAGULATION WITH HEPARIN INFUSION IN ADDITION TO STANDARD DUAL ANTIPLATELET THERAPY (ASPIRIN 325 MG AND CLOPIDOGREL 75MD DAILY). THE PATIENT AWOKE WITH A LEFT PRONATOR DRIFT BUT NEUROLOGICALLY INTACT. CT STILL SHOWED DELAYED FLOW THROUGH THE RIGHT MCA. ON THE FOLLOWING DAY, DSA FOUND THROMBUS FORMATION ALONG THE PROXIMAL PED WITH SLUGGISH FILLING OF THE DISTAL MCA. AN ATTEMPTED THROMBOLYSIS WAS PERFORMED WITH INFUSION OF 10 MG OF ABCIXIMAB, BUT WAS UNSUCCESSFUL. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE PED UTILIZING A VARIETY OF DEVICES (GOOSE NECK SNARE, ALLIGATOR, MERCI RETRIEVER) BUT ALL WERE UNSUCCESSFUL. THE PROCEDURE WAS ULTIMATELY ABORTED. ANGIOGRAM SHOWED AT THIS POINT A LARGE, FLOW-LIMITING THROMBUS IN THE M1 TRUNK AND VERY SLUGGISH FLOW DISTALLY. AT THIS POINT THE PATIENT BEGAN TO DEVELOP A DENSE LEFT-SIDED HEMIPARESIS AFTER FAILED RETRIEVAL AND POST-PROCEDURE MAGNETIC RESONANCE IMAGING (MRI) DEMONSTRATED MULTIPLE ACUTE RIGHT MCA DISTRIBUTION THROMBOEMBOLIC INFARCTS. MICROSURGICAL EXTRACTION OF THE PED WAS PERFORMED TO RESTORE THE FLOW TO THE MCA. A WIDE RIGHT SIDE CRANIOTOMY WAS PERFORMED. IMMEDIATELY EVIDENT UPON DURAL OPENING, A CALCIFIED DOME WAS OPENED AND THE INTRA-ANEURYSMAL THROMBUS WAS DEBULKED. ONCE THROMBUS WAS REMOVED, THE LUMEN OF THE MCA WAS EXPOSED AND THE PED WAS EASILY REMOVED. THE PROXIMAL MCA M1 SEGMENT WAS IDENTIFIED JUST DISTAL TO THE ICA BIFURCATION AND PROXIMAL VASCULAR CONTROL WAS ACHIEVED WITH A TEMPORARY CLIP. M2 BRANCHES WERE SEEN INCORPORATED WITHIN THE ANEURYSM NECK. THE EXCESS ANEURYSM DOME WAS RESECTED BUT DUE TO THE ANATOMY OF THE NECK THE OPENED ANEURYSM DOME COULD NOT BE RE-APPROXIMATED WITH A CLIP. THE ANEURYSM WAS RESECTED, RESULTING IN DETACHMENT OF THE POSTERIOR MCA M2 DIVISION FROM M1 TRUNK. THEY ATTEMPTED TO REANASTOMOSE THE POSTERIOR M2 DIVISION TO THE M1 BUT DUE TO THE FRIABLE NATURE OF THE VESSEL WALLS, THE 8-0 NYLON SUTURE WOULD NOT HOLD. THE PROCEDURE WAS ABORTED TO PREVENT HYPERPERFUSION INJURY. THE CLIPS WERE LEFT IN PLACE AND THE BONE FLAP WAS LEFT OFF TO ALLOW FOR INFARCT-RELATED EDEMA. PATIENT AWOKE FROM SURGERY WITH A DENSE LEFT-SIDED HEMIPLEGIA. THE PATIENT UNDERWENT PERCUTANEOUS GASTROSTOMY AND DISCHARGED 1 WEEK LATER. SHE ALSO UNDERWENT CRANIOPLASTY TWO MONTHS LATER WITH AN UNCHANGED NEUROLOGICAL EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661635 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71325-25 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention| S