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

Device Problem Activation Failure (3270)

Patient Problems Edema (1820); Ischemia (1942); Thrombosis (2100)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

Sack, j.(2017).Surgical resection and histopathological analysis of a thrombosed giant fusiform mca aneurysm after initial treatment with a flow diversion construct.World neurosurgery, 103, 348-354.Doi:10.1016/j.Wneu.2017.04.070 the pipeline device has not been returned for evaluation as it remains implanted in the patient.The patient anatomy condition and the pipeline model were not reported; any contributing factors from the patient anatomy and the pipeline model could not be assessed.The report of pipeline failure to open could not be confirmed, and the cause could not be conclusively determined from the provided information.In addition, the patient experienced in-stent thrombosis after pipeline implantation.The information provided does not suggest that a device defect led to the post-procedure thrombosis and ischemia; rather, the presence of the device itself and patient responsiveness to antiplatelets contributed to the event.In-stent thrombosis and ischemia are known potential complications of the pipeline device and are identified in the instructions for use.Mdrs related to this article: 2029214-2017-00795 2029214-2017-00796 2029214-2017-00797.

Event Description

Medtronic literature review found report of pipeline embolization device (ped) failure to open during a procedure as well as in-stent thrombosis after implantation of a ped construct.The patient presented to the emergency department after one week of progressive confusion and lethargy.The patient was oriented to person, but not to place or time.The patient exhibited right facial droop and right hemibody weakness.Imaging revealed a 5.4cmx5cmx4cm aneurysm in the left middle cerebral artery (mca) with significant local mass effect and perilesional edema.The patient opted to undergo endovascular treatment of the aneurysm in which overlapping flow diverters would be implanted.The patient had been receiving aspirin (therapeutic at 445 aspirin reaction units [aru] nl <(><<)>550 aru) and clopidogrel for 3 days before ped insertion.The patient was pretreated with aspirin and plavix.A p2y12 platelet inhibition assay was borderline therapeutic, and thus the patient received an additional dosage of plavix 75 mg immediately after the procedure.Activating clotting time was not monitored during ped insertion.Three overlapping peds were deployed across the body of the aneurysm from the proximal m1 segment to the distal m1 outflow tract.A stent from another manufacturer was used to anchor the most distal ped at the distal outflow tract before deploying the more proximal construct, given the calcified outflow track and the inability to gain full expansion of the ped until the team deployed the self-expanding stent.Final angiographic images demonstrated appropriate in-phase filling of the distal mca branches and marked stasis of contrast within the body of the aneurysm.The patient received an additional one-time dose of plavix 75 mg after the procedure and was started on a daily dose of aspirin 325 mg and plavix 75 mg thereafter.A postoperative head computed tomography scan did not reveal any acute pathology.One day post-implantation, sedation was weaned; left gaze preference and right hemiparesis were noted.An emergent computed tomography angiogram of the head revealed in-stent thrombosis.Emergent diagnostic cerebral angiography demonstrated complete occlusion.The occlusion was treated with intraarterial eptifibatide at the left m1 segment, and a continuous drip was subsequently administered for 24 hours.The ped construct did not recanalize.Follow-up magnetic resonance imaging of the brain demonstrated patchy left mca strokes and significant, progressive local mass effect and cerebral edema owing to the giant thrombosed aneurysm.Eight days after embolization, the patient underwent a left-sided craniotomy for en bloc resection of the aneurysm.No suitable recipient vessel for direct bypass was identified, and thus the superficial temporal artery was dissected and laid over the pial surface with the intent of inducing delayed revascularization.The patient¿s neurologic status did not deteriorate any further.The patient was subsequently discharged.Delayed follow-up cerebral angiography demonstrated engraftment of the superficial temporal artery pedicle with collateral supply to the mca territory.The patient demonstrated progressive clinical improvement.At the 1-month follow-up, the patient¿s mental status and language production were improved with a final modified rankin scale score of 4.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6652808
• MDR Text Key: 77916266
• Report Number: 2029214-2017-00795
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• 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,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• 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; Disability
• Patient Age: 75 YR