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); Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Ischemia (1942); Occlusion (1984); Transient Ischemic Attack (2109); Loss of Vision (2139); Stenosis (2263); Therapeutic Response, Decreased (2271)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

Almandoz, j.E., kayan, y., tenreiro, a., wallace, a.N., scholz, j.M., fease, j.L.,.Tenreiro-picón, o.(2017).Clinical and angiographic outcomes in patients with intracranial aneurysms treated with the pipeline embolization device: intra-procedural technical difficulties, major morbidity, and neurological mortality decrease significantly with increased operator experience in device deployment and patient management.Neuroradiology, 59(12), 1291-1299.Doi.Org/10.1007/s00234-017-1930-z.The pipeline devices will not be returned for evaluation as they remain implanted in the patients.Based on the provided information, there does not appear to have been any defects of the devices during use.The events occurred in the patients post-procedure and its cause could not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2018-00220, 2029214-2018-00222, 2029214-2018-00223, and 2029214-2018-00224.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of patient complications after pipeline implantation.The purpose of this article was to determine whether outcomes after pipeline (ped) treatment improve with operator experience.The authors retrospectively reviewed 140 patients who underwent 150 ped procedures to treat 167 intracranial aneurysms.Of the patients, 109 were women and 31 were men; the mean age was 55.4 years.The article noted the following peri-operative complications: - five major ipsilateral intracerebral hemorrhages (ich).It was noted that four of the five patients had marked p2y12 receptor over-inhibition (pru = 10) at the time of ich - four major ipsilateral ischemic strokes - five minor ipsilateral ischemic strokes with transient deficits - one ipsilateral peripheral subarachnoid hemorrhage the article noted the following delayed complications: - one central retinal artery occlusion with monocular blindness after aspirin discontinuation 2.5 years after the ped procedure - two asymptomatic ped occlusions - one amaurosis fugax - one ipsilateral ischemic stroke with transient deficits the article also notes that four patients underwent retreatment in which an additional ped was placed.

• 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: 7366031
• MDR Text Key: 103322706
• Report Number: 2029214-2018-00221
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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: 02/27/2018
• 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