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 Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Therapeutic Response, Decreased (2271); Thromboembolism (2654); Hydrocephalus (3272)

Event Date 11/26/2015

Event Type  Injury  

Manufacturer Narrative

Daou, b.Et al.(2015).Pipeline embolization device in the treatment of recurrent previously stented cerebral aneurysms.American journal of neuroradiology, 37(5), 849-855.Doi:10.3174/ajnr.A4613 the pipeline devices will not be returned for evaluation as they remain implanted in the patients.Based on the information provided in the article, there did not appear to have been any defects of the devices during use.The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-00521 2029214-2017-00522 2029214-2017-00523.

Event Description

Medtronic literature review found reports of patient complications during or after pipeline implantation.The purpose of this article was to evaluate the efficacy and safety of the pipeline embolization device (ped) in the treatment of recurrent, previously-stented aneurysms.The authors identified 21 patients with previously-stented recurrent aneurysms who underwent retreatment with ped.These patients were compared with 63 patients who had treatment with the ped without prior stent placement.Of the previously-stented group, two previously-stented aneurysms managed with the ped required another retreatment, with placement of another ped.In patients with no prior stents, four patients required retreatment post-ped placement.Of the previously-stented group, four patients had an unfavorable outcome (19%), which included one patient with an mrs score of 3, one patient with an mrs of 4, and one patient with an mrs of 5.In patients with no prior stent placement, 6.8% of patients had a ¿poor clinical outcome.¿ the article states that three patients in the previously-stented group experienced complications within 30 days of treatment: - one patient with a giant vertebrobasilar artery aneurysm had a posterior cerebral artery territory infarct and later developed hydrocephalus requiring ventriculoperitoneal shunting and then developed multiple shunt infections (mrs 5).- one patient had retinal emboli causing visual changes (mrs 1) after ped treatment of a carotid ophthalmic aneurysm.The article states that six patients in the ped-only group experienced complications within 30 days of treatment.The complications included two intracerebral hemorrhages, one mca infarcts, and one basal ganglia stroke.

• 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: 6517579
• MDR Text Key: 73557656
• Report Number: 2029214-2017-00522
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• 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: 03/28/2017
• 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