MAUDE Adverse Event Report: MICROVENTION, INC. FRED 3.5X17X11; STENT

Model Number 45-750617

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2020

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.

Event Description

It was reported that the (b)(6) did not open spontaneously during deployment.The microcatheter was used to manipulate the stent to achieve a satisfactory result.At the end of the procedure, the fred was correctly expanded, the parent artery was patent without stenosis, and the fred covered the aneurysm neck as planned.The patient was discharged the next day with an mrs=2, which was unchanged from the patient's mrs score of 2 upon admission.There was no reported patient injury.

• Brand Name: FRED 3.5X17X11
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9742502
• MDR Text Key: 188689621
• Report Number: 2032493-2020-00043
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00811425020968
• UDI-Public: (01)00811425020968(11)180206(17)210131(10)18020655K
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P180027
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Model Number: 45-750617
• Device Lot Number: 18121356W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• 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: 46 YR