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

Model Number FA-77425-12

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2015

Event Type  Injury  

Event Description

Medtronic (covidien) received information regarding an incident involving one of its devices.Treatment of an unruptured amorphous aneurysm measuring 10.5mm x 6.50mm located in the ophthalmic segment of the left ica (internal carotid artery).During the procedure with tortuous anatomy, it was reported the marksman catheter pushed the pipeline into the aneurysm after it was successfully deployed.Another pipeline was implanted successfully telescoping the first pipeline.There was full wall apposition in both pipelines.Post procedural angiogram showed an eclipse.The patient was fine and discharged the next day no patient injury was reported as a result of the procedure.

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it was implanted in the patient.The lot history record review of the reported lot number showed no discrepancies that might have contributed to the reported experience.(b)(4).

• 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: 4635880
• MDR Text Key: 5753159
• Report Number: 2029214-2015-00297
• 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: 02/25/2015

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
• Device Expiration Date: 12/30/2017
• Device Model Number: FA-77425-12
• Device Lot Number: A036777
• Other Device ID Number: 00836462014510171230A036777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2014
• 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: 65 YR