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

Model Number FA-77475-18

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 02/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation as it was implanted.Vasospasm is a known inherent risk of pipeline procedure and is documented in the pipeline flex instruction for use.Based on the reported information, there is no evidence suggesting that device was defective, but rather a procedure related event.

Event Description

Medtronic received information that a patient experienced vasospasm during pipeline procedure.The patient was treated for a small unruptured right paraopthamic internal carotid artery (ica) aneurysm.The pipeline embolization was deployed and there was stasis of contrast noted within the aneurysm, as expected.The flow through the opthalmic artery was noted to be slow and there was evidence of vasospasm involving the distal ica, so 30 mg of intra-arterial verapamil was administered and a balloon was used to perform angioplasty within the ped.This resulted in good wall apposition and opening of the stent throughout and improved flow within the right opthalmic artery.There were no local or distal thromboembolic complications demonstrated on the conclusion angiography.The patient awoke with no new neurological deficits.The patient was commenced on a therapeutic heparin infusion to avoid complications with flow through the opthalmic artery.No patient injury was reported as a result of this procedure.

• Brand Name: PIPELINE
• 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 ; 9498373700
• MDR Report Key: 5163763
• MDR Text Key: 28838352
• Report Number: 2029214-2015-05059
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2016
• Device Model Number: FA-77475-18
• Device Lot Number: 9777443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Date Device Manufactured: 07/22/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00058 YR