MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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

Patient Problems Ischemia (1942); Neurological Deficit/Dysfunction (1982)

Event Date 01/20/2015

Event Type  Injury  

Manufacturer Narrative

Citation: francesco briganti, luigi delehaye, giuseppe leone, et al."flow diverter device for the treatment of small middle cerebral artery aneurysms." j neurointervent surg 2016;8:287¿294.The devices involved in the event will not be returned for evaluation as they were implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patients post procedure and its cause was unknown.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 review of literature that post pipeline treatment, four patients experienced ischemic complications with 3 permanent neurological deficits.Complete occlusion was obtained in 12/15 aneurysms (80%) and partial occlusion in 3 (20%).Among 13 aneurysms with a side branch, they were patent at the angiographic control in 4 cases, showed decreased filling in 6, and was occluded in 3 (with neurological deficits in 2).All peds were patent at follow-up.Post-procedural ischemic complications occurred in 4 (27%) patients with permanent neurological deficit (modified rankin score 2) in 3 patients (21%).

Manufacturer Narrative

Patient information added to section.

Event Description

In this study a total of 14 patients were treated (10 women; mean age 59 years).

Manufacturer Narrative

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

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5775468
• MDR Text Key: 48963411
• Report Number: 2029214-2016-00514
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• 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: 06/08/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 59 YR