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

Model Number	FRED4017-PMA
Medical Device Problem Codes	Retraction Problem (1536); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
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 returned to the manufacturer for investigation.The investigation is underway.
Event or Problem Description
It was reported that during deployment, the fred did not open around a turn in the vessel after approximately 20-30% of the fred had been deployed.The fred was then unable to be resheathed back into the microcatheter.The partially open stent was removed together with the microcatheter from the patient through the intermediate support catheter.There was no reported patient injury or additional intervention.The patient was discharged home and reported to be stable and neurologically intact.
Additional Manufacturer Narrative
Upon initial investigation, there was no damage found on the stent.The stent was reloaded and was able to be advanced and resheathed into the catheter.The stent fully deployed without any issues.The proximal marker band 's outer diameter and the microcatheter's inner diameter were measured and found to be in specification.Two images provided by the customer were inspected.The stent appears that it may have been covered with an excess amount of blood, indicated by the stent being covered in red spots, which may have impacted its ability to be resheathed into the microcatheter.The investigation of the returned stent found it was able to deployed and resheathed without issue during lab testing.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.The images provided by the customer shows that the alleged resheathing issue may have been the result of excessive blood, bio-contaminates, or residue, but this cannot be confirmed by the image alone.Based on the physical evaluation of the device alone, the complaint is unconfirmed.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10192992
• Report Number: 2032493-2020-00148
• Device Sequence Number: 3298097
• 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): 05/26/2020

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: 06/16/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1