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 Thromboembolism (2654)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during implantation.The event cause could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-00260 2029214-2017-00261 2029214-2017-00262.

Event Description

Medtronic received information from literature that a patient experienced thromboembolism during pipeline implantation.The article states that a patient was undergoing pipeline implantation in the treatment of an unruptured, ophthalmic artery aneurysm.During the procedure, the patient experienced acute clot, which embolized to an m3 pre-rolandic branch.The clot resolved following intra-arterial administration of abciximab.The patient initially awoke from left-sided weakness and headache, although this significantly improved and his discharged mrs was the same as his mrs at presentation.There were no reports of device issues in connection with this event.Durst, c.R.(2015).Endovascular treatment of ophthalmic artery aneurysms: ophthalmic artery patency following flow diversion versus coil embolization.Journal of neurointerventional surgery, 8(9), 919-922.Doi:10.1136/neurintsurg-2015-011887.

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 ; 9496801224
• MDR Report Key: 6441589
• MDR Text Key: 71094318
• Report Number: 2029214-2017-00261
• 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,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: 03/03/2017
• Supplement Dates FDA Received: 10/02/2017
• 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): Required Intervention