MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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

Patient Problems Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982); Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

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.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure and patient condition related event.If information is provided in the future, a supplemental report will be issued.

Event Description

Letter: rerupture of a blister aneurysm after treatment with a single flow-diverting stent (leonardo b.C.Brasiliense, md, christina m.Walter, ms, mauricio j.Avila, md, mphe, travis m.Dumont, md).A (b)(6) female presented to the emergency department with a thunderclap headache (hunt and hess grade 2, world federation of neurosurgical societies grade 1) and computed tomography (ct) scan revealed diffuse subarachnoid hemorrhage.Informed consent was neither required nor sought after for the manuscript based on its retrospective nature and minimal risk for the patient.During the angiogram, a 3-mm blister-like aneurysm was identified on the ventral left supraclinoid internal carotid artery.A pipeline flex was selected, given the small aneurysm dome and high perceived risk of aneurysm rupture during catheterization.A single device was deployed from the distal internal carotid artery (ica) to the proximal cavernous ica uneventfully and final runs demonstrated adequate device apposition and no evidence of endoleak.Of note, the patient had been loaded with aspirin (650 mg) and clopidogrel (600 mg) on the morning of the procedure.She continued to complain of headache until the second day following aneurysm treatment, when she had a sudden onset of expressive aphasia, right facial droop, and right hemiplegia.Ct perfusion was obtained emergently, which revealed a new subarachnoid hemorrhage (sah) around the pipeline and complete occlusion of the device.In addition, her perfusion scan showed an infarct core involving the anterior temporal and inferior frontal lobes, without areas of penumbra in the adjacent white matter, which was likely the result of thromboembolism from the pipeline embolization device occlusion.The remaining left middle cerebral artery territory was well perfused from the contralateral ica.The patient remained clinically stable throughout hospitalization and was discharged to a rehab facility on hospital day 18 without neurological improvement (modified rankin score 4).The use of flow diversion for ruptured blister aneurysms is a relatively novel and controversial strategy.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8750624
• MDR Text Key: 149714194
• Report Number: 2029214-2019-00655
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2019
• 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): Other