MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-475-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paresis (1998)

Event Type  Injury  

Manufacturer Narrative

Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure related event.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received the following report through literature review of ¿progressive edematous lesions in subacute phase after neuroendovascular therapy¿ (tomoyoshi kuribara, koichi haraguchi, shunya ohtaki, tadakazu shimizu, nobuki matsuura, kazumi ogane, yasunori maruo, noriyuki yokoyama, takeshi mikami, takeo itou, and nobuhiro mikuni).A (b)(6) female with a history of nephrotic syndrome and hypertension presented with a persistent headache at her local clinic.A right thrombosed cavernous internal carotid artery aneurysm measuring 22.5 × 19.7 × 19.2 mm was detected on computed tomography angiography (cta).She was introduced to our hospital and underwent flow diverter deployment for the aneurysm with a pipeline embolization device (ped).Under general anesthesia, a 5 fr navien 058 intracranial support catheter and a marksman catheter were advanced over the neck of the aneurysm using a 0.014-inch asahi chikai microguidewire through the shuttle sheath.A 4.75/20 mm ped was deployed to cover the neck of the aneurysm through the triaxial system, and the stent was re-sheathed twice.The procedure was performed in 61 min without any complications, though diffusion weighted imaging (dwi) after the procedure revealed a few scattered hyperintensities in the right hemisphere.Fifteen days after the procedure, left hemiparesis developed and multiple edematous lesions were revealed in the right hemisphere on magnetic resonance imaging (mri) 28 days after the procedure.The hemiparesis gradually progressed, and the edematous lesions were enlarged on mri.At this time, white blood cell count was 149 × 102 cells/mm, c-reactive protein was 2.37 mg/dl, and creatinine was 1.28 mg/dl.Three courses of steroid pulse therapy (intravenous administration of methylprednisolone 1000 mg daily × 3 days and oral prednisolone 50 mg daily × 4 days) were then performed.Subsequently, hemiparesis was improved in association with the improvement of edemas.Eighty-one days after the procedure, the edemas were diminished, though nodular enhancing lesions were persistent on contrast-enhanced mri.During the 6-month follow-up periods, there has been no recurrence and no neurological deficits.Delayed allergic reactions might be associated to the complications, although there is no finding to support this.In terms of embolic sources, cotton fibers have been reported in previous studies, though hydrophilic polymers applied as a surface coating on endovascular catheters are the most common cause in recent years.From dwi findings, the scattered hyperintensities after the procedure are thought to be foreign body emboli and inflammatory cells surrounding them rather than acute cerebral infarctions, because their locations seem to be atypical for ischemic lesions and are at center of each edematous lesion.Moreover, the edematous lesions surrounding them are considered to be vasogenic edemas, and steroid therapy should be theoretically appropriate for such lesions.Steroid therapy is reported to result in relatively good prognoses.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8776627
• MDR Text Key: 150580813
• Report Number: 2029214-2019-00712
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED-475-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR