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 Problem Therapeutic Response, Decreased (2271)

Event Date 09/16/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned as it was implanted in the patient.The purpose of this article was to report the outcome of patients with cerebral aneurysms that incorporated an end vessel at the aneurysm neck or dome, which were treated by flow diversion using the pipeline embolization device.All patients either had post treatment dynact showing good wall apposition or had pta, and therefore it is unlikely that a persistent flow between the device and parent vessel was a contributing factor to the patency of the artery.There was also consistent antiplatelet regimen on the patients including clopidogrel for 6 months and aspirin dose reduction to 81 mg at 6 months.As a result, persistent patency was not likely to be related to dual antiplatelet therapy.The authors conclude that the use of flow diversion for treatment of aneurysms incorporating an end vessel is not recommended as it appears ineffective for complete aneurysm occlusion.In this case, the patient did require retreatment via surgical clipping.Based on the information discussed in the article, the reported events are not related to a malfunction of the pipeline device, but rather related to the patient conditions and subset of cerebral aneurysm that was treated.Citation: akil patel,timothy r miller, ravi shivashankar, gaurav jindal, dheeraj gandhi.Early angiographic signs of acute thrombus formation following cerebral aneurysm treatment with the pipeline embolization device.J neurointervent surg 2016.Mdrs from this literature review: 2029214-2017-00206 and 2029214-2017-00207.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through literature that the aneurysm did not achieve significant occlusion at the last follow-up evaluation.The patient had raymond scale scores of 3 (no occlusion) and szikora scale scores of 0 (no stasis of flow after flow diverter placement).The aneurysm required retreatment.The (b)(6) patient presented with an aneurysm in the right ophthalmic artery (opha) measuring 4.1 mm.The end vessel was the right opha.The aneurysm was treated with a pipeline 3.75 x 14.Post treatment dynact showed good wall apposition.The patient was placed on a dual antiplatelet therapy including clopidogrel for 6 months and aspirin dose reduction to 81 mg at 6 months.At the follow up after 12 months, the aneurysm showed no occlusion and no stasis of flow after flow diverter placement.This patient underwent retreatment by surgical clipping of the right opha aneurysm.

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 ; 9498373700
• MDR Report Key: 6420778
• MDR Text Key: 70448016
• Report Number: 2029214-2017-00207
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• 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: 03/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 50 YR