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

Model Number PED-450-35

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

Patient Problem Paresis (1998)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis, as it was implanted in the patient and the delivery system was discarded at the site.Based on the reported information there was no device malfunction or deficiency.This event appears to be related to the patient's failure to follow the treating physician medical advice, the patient did not start the antiplatelet medication correctly.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that one-day post flow diverter procedure, the patient developed left side weakness.One-day post procedure, the patient woke up with weak left side movement.Tests were performed, and it had been discovered that a clot was present in the flow diverter and carotid artery.Aspiration was performed to remove the clot.All the clot was removed, but it was noticed a piece showered off from the carotid into the m1/m2 bifurcation.A mechanical thrombectomy device was then used to retrieve the small amount of clot, but there was difficulty with catheter access (competitor catheter), the microcatheter and mechanical thrombectomy device could only reach part of the clot, as a result of the competitor support catheter that was used.Tortuosity also limited the ability to get the catheter beyond the entire clot.The competitor catheter was deployed short of the entire length of clot.It was alleged that the patient did not taken the dapt, even though it was prescribed prior to the procedure.

• 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: 7161228
• MDR Text Key: 96329975
• Report Number: 2029214-2018-00014
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2020
• Device Model Number: PED-450-35
• Device Lot Number: A471829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2017
• 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: 55 YR