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

Model Number	FREDX5015-PMA
Medical Device Problem Codes	Retraction Problem (1536); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2032493-2023-01145
• Device Sequence Number: 14143108
• Product Code: OUT
• UDI-Device Identifier: 00842429114445
• UDI-Public: (01)00842429114445(11)210707(17)240630(10)0000180092
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 93 KG