MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number FRED3536-PMA

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Thrombus (2101)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for evaluation.The root cause cannot be determined.The instructions for use (ifu) identifies vessel stenosis or thrombosis as potential complications associated with use of the device.

Event Description

It was reported that the fred was used as treatment for a tortuous m2 to m1 fusiform aneurysm with two curves.The fred was delivered smoothly; however, the proximal stent did not completely open upon deployment.Thrombus formation was observed inside the proximal portion of the fred.Integrilin was administered through the microcatheter at the proximal portion of the device.Aspiration was attempted, but was not successful.After multiple manipulations of the device with the microcatheter and microwire, the fred completely opened and the thrombus within the device was no longer visualized.No neurological deficits or abnormalities were observed during the post-procedure neurological exam of the patient.The patient is currently reported to be doing well.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10495426
• MDR Text Key: 205711832
• Report Number: 2032493-2020-00241
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106693
• UDI-Public: (01)00842429106693(11)190513(17)220430(10)190513558M
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180027
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: FRED3536-PMA
• Device Lot Number: 190513558M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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