MAUDE Adverse Event Report: MICROVENTION, INC. FRED X27; INTRALUMINAL DEVICES

Model Number FREDX5015-PMA

Device Problems Retraction Problem (1536); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  malfunction  

Event Description

As reported through a fred x clinical study, the fred x deployed as intended at the distal landing zone, opened across the neck, but failed to open along the proximal curvature.The fred x could not be captured, retracted within the microcatheter.The device was successfully recaptured through the advancement of the intermediate catheter.A pipeline stent was placed successfully.No patient harm was reported.

Manufacturer Narrative

The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be verified.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.If additional information is received a supplemental mdr report will be provided.The instructions for use (ifu) identifies device retraction difficulty as potential complications associated with use of the device.

• Brand Name: FRED X27
• Type of Device: INTRALUMINAL DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18387539
• MDR Text Key: 331499146
• Report Number: 2032493-2023-01145
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429114445
• UDI-Public: (01)00842429114445(11)210707(17)240630(10)0000180092
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FREDX5015-PMA
• Device Lot Number: 0000180092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 93 KG