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

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

Patient Problems Intimal Dissection (1333); Therapeutic Response, Decreased (2271)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Ryan, r.W., khan, a.S., barco, r., choulakian, a.(2017).Pipeline flow diversion of ruptured blister aneurysms of the supraclinoid carotid artery using a single-device strategy.Neurosurgical focus, 42(6).Doi:10.3171/2017.3.Focus1757.The pipeline devices will not be returned for evaluation as they were implanted in the patients; product analysis cannot be performed.The events reported in this article could not be confirmed.From the information provided, the events do not appear to be due to a device defect; the cause of the events could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-00852 and 2029214-2017-00853.

Event Description

Medtronic literature review found reports of intraprocedural hemorrhage and retreatment after pipeline implantation as well as pipeline braid foreshortening.The purpose of this article was to describe the experience with the use of pipeline embolization device (ped) flow diversion for treatment of ruptured blister aneurysms.The authors identified 13 patients who presented with subarachnoid hemorrhage from ruptured blister aneurysm(s).All patients were treated with pipeline flow diversion.Of the patients, 11 were women and 2 were men.Blister aneurysms were defined as small lesions occurring on the sidewall of the internal carotid artery (ica) at nonbranching sites and having a dome width equal to or great than its height.The article states that in one case, a second overlapping ped was placed after the intended single pipeline device placement resulted in unsatisfactory lesion coverage due to device foreshortening.The article also states that in case 12, the patient ((b)(6), female) experienced an intraprocedural hemorrhagic complication as a result of wire perforation during repositioning for placement of a second ped.The patient was undergoing treatment for a 2 mm x 1 mm blister aneurysm in the right ica.After perforation, the patient required reversal of anticoagulation and antiplatelets, decompressive craniectomy, as well as placement of an external ventricular drain.The patient's mrs was 5 as of the last follow-up.The article states that retreatment was required in some patients: in case 4, the patient ((b)(6), female) underwent retreatment more than a year after ped implantation.The patient had presented with sudden onset of severe headache (hunt and hess grade ii), and a head ct demonstrated right-sided sah in the basal cisterns and sylvian fissure (fisher grade 2).The patient underwent diagnostic cerebral angiography, which demonstrated 2 right-sided superior hypophyseal artery blister aneurysms measuring 1.5 mm each.Three days later, the patient underwent embolization of the aneurysms using the ped.The patient was discharged home in good condition.The 3-month follow-up cerebral angiogram showed endoleak at the proximal aspect of the pipeline with delayed filling of both aneurysms, but with contrast stagnation.Six-month, 1-year, and 15-month follow-up cerebral angiograms showed no interval occlusion of the aneurysms, and the patient subsequently underwent retreatment of the lesions with placement of a pipeline flex embolization device.A 6-month follow-up cerebral angiogram after retreatment demonstrated interval occlusion of the proximal aneurysm, with continued delayed filling of the distal aneurysm.No patient developed new neurological deficits during follow-up.

• 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: 6688119
• MDR Text Key: 79120938
• Report Number: 2029214-2017-00851
• 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
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• 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: 06/09/2017
• 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): Other; Required Intervention