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

Model Number PED-425-16

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

Patient Problem Stenosis (2263)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned as it was implanted in the patient.Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the device occurred during the treatment procedure.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a patient condition related event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received core lab data report: significant parent artery stenosis > 50% at 1 year and 2 year angiogram.In this case the patient was reported to be asymptomatic.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irivne CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irivne CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7382730
• MDR Text Key: 103866114
• Report Number: 2029214-2018-00238
• 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
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/21/2017
• Device Model Number: PED-425-16
• Device Lot Number: A052266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2014
• 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): Other
• Patient Age: 48 YR