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

Model Number	FRED4017-PMA
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance 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 received by the manufacturer for investigation.
Event or Problem Description
It was reported that approximately 25% of the stent could not be recaptured by the microcatheter.The stent and microcatheter were withdrawn together into the intermediate support catheter and removed from the patient without incident.There was no reported patient injury.The patient's final condition was reported to be good.
Additional Manufacturer Narrative
The stent was returned for evaluation.A new pusher, introducer and microcatheter were used for the investigation.Upon initial observation, no damage was found on the stent.The stent was reloaded back into the introducer and deployed through the microcatheter without issue.The root cause of the complaint cannot be determined, as the stent was undamaged and was able to be recaptured.The root cause of this complaint may have been due to tortuous anatomy which may have made it difficult to retrieve during the procedure.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10197775
• Report Number: 2032493-2020-00152
• Device Sequence Number: 11587711
• Product Code: OUT
• UDI-Device Identifier: 00842429106730
• UDI-Public: (01)00842429106730(11)191007(17)220930(10)19100755TM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: FRED4017-PMA
• Device Lot Number: 19100755TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1