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

Model Number FRED4007-PMA

Device Problem Retraction Problem (1536)

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

Event Date 09/19/2020

Event Type  malfunction  

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 returned to the manufacturer for evaluation.The investigation is currently underway.

Event Description

It was reported that the fred was placed within another fred during treatment of an internal carotid artery (ica) aneurysm.After the fred was deployed, the delivery wire became caught on the stent during retraction.The delivery wire released from the fred with additional manipulation of the wire.There was no reported patient injury.

Manufacturer Narrative

The distal tip of the pusher was found to be damaged consistent with the sequence of events in the reported event.Because of the damage to the distal tip and the fact that the stent was implanted, the user experience was not able to be replicated.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.All critical dimensions of the delivery system were measured and found to be within specification.This device was used during the same procedure as the device referenced in mfr.Report # 2032493-2020-00294.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10702541
• MDR Text Key: 212122970
• Report Number: 2032493-2020-00295
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106709
• UDI-Public: (01)00842429106709(11)200730(17)230630(10)200730571
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: FRED4007-PMA
• Device Lot Number: 200730571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1