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

Model Number FA-77425-20

Device Problem Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

Medtronic (covidien) received information that during a flow diversion treatment of a left unruptured internal carotid artery (ica) cavernous and ophthalmic segment wide neck, fusiform aneurysm, the physician observed that the green coating was detached from the delivery wire after two pipeline devices were delivered.Both of the pipeline devices were implanted successfully.The physician did not experience any difficulties during the delivery of the devices; however the physician felt resistance trying to pull the system out of patient in the entire parts of both catheters.The loose coat pieces were found in the microcatheter and the rhv.One pushwire with the coating loose problem was sent for device investigation.The other pushwire and the microcatheters were discarded.No patient injury was reported as a result of this procedure.

Manufacturer Narrative

The device was not returned for analysis; therefore the complaint could not be confirmed, and the event cause could not be determined.The lot history record review of the reported lot number showed no discrepancies that may have contributed to the reported experience.Same event as reported in 2029214-2015-00306.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine 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: 4639071
• MDR Text Key: 5596526
• Report Number: 2029214-2015-00307
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• 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: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: FA-77425-20
• Device Catalogue Number: FA-77425-20
• Device Lot Number: 9793991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2013
• 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
• Patient Age: 50 YR