MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX 4.00MM X 16MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-400-16

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Impairment (2138)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis as it was implanted in the patient.Vision impairment are known inherent risk of endovascular embolization procedure and is documented in the device's instruction for use.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that this patient experienced visual disturbance described as "shooting stars", post aneurysm treatment and is continuing.The aneurysm treated was located in the c6 segment of the right ica.The aneurysm dome was 3.33 mm and the neck diameter was 3.8 mm.

Event Description

Medtronic received additional information during follow up it was identified that this patient experienced visual disturbance described as "shooting stars," post pipeline treatment.The date of onset is currently unknown but was sometime in (b)(6) 2016.The patient was treated with the pipeline on (b)(6) 2016 and the follow up was performed on (b)(6) 2016.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX 4.00MM X 16MM
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6205025
• MDR Text Key: 63306760
• Report Number: 2029214-2016-01135
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/22/2018
• Device Model Number: PED-400-16
• Device Lot Number: A047734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Date Device Manufactured: 01/23/2015
• 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): Other
• Patient Age: 47 YR