MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FA-77375-10

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

Medtronic (covidien) received information that during a flow diversion treatment of a blister ruptured left supraclinoid internal carotid artery (ica) aneurysm (maximum diameter 3.4 mm, neck width 3mm), the physician reported that a pipeline embolization device deployed prematurely and did not open proximally.It was reported that the aneurysm ruptured a week prior to the procedure.The physician rotated and pulled back the pushwire during procedure which caused the pipeline prematurely deployed in the m1 segment of the middle cerebral artery (mca) as the physician was attempting to pull the device down into the ica.It was reported that the pipeline did not open proximally which prompted the physician to use a balloon to open the proximal end.A full wall apposition was achieved after ballooning.The aneurysm was subsequently treated with two pipeline devices and both devices were deployed without incident.Angiography result post procedure showed slow flow in the aneurysm.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

Off label use: the pipeline embolization device (ped) is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments.The pipeline was not returned for analysis; therefore, the event causes could not be determined.The lot history record review of the reported lot number showed no discrepancies that would have contributed to the reported experience.

• 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 ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4665893
• MDR Text Key: 20149575
• Report Number: 2029214-2015-00354
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2016
• Device Model Number: FA-77375-10
• Device Lot Number: 9957934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2013
• 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