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

Model Number PED-425-20

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

Patient Problems Inflammation (1932); Thrombosis (2100)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis as it was implanted in the patient.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.Inflammation and thrombosis formation are known inherent risk of endovascular procedure and are documented in the pipeline instruction for use.Based on the reported information, there was no allegation that a malfunction or deficiency of the device occurred during the procedure.There is no evidence suggesting that the device was defective, but rather a post procedure and patient condition related event.However, the exact cause remains unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that post pipeline embolization procedure, the patient developed inflammation due to thrombus not mass effect.It was determined the symptom were not related to the device or the flow diverter treatment.The issue was not critical, and the patient was confirmed to have recovered approximately 5 months post intervention.The cerebral aneurysm was reported to have been 25mm.

• Brand Name: PIPELINE FLEX
• 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 ; 9492753836
• MDR Report Key: 7073464
• MDR Text Key: 93419667
• Report Number: 2029214-2017-01318
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2018
• Device Model Number: PED-425-20
• Device Lot Number: A117742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2015
• 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: 68 YR
• Patient Weight: 47