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

Model Number MV-F501927

Device Problems Difficult to Remove (1528); Activation Failure (3270)

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

Event Date 09/17/2021

Event Type  Injury  

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 implanted in the patient and not returned to the manufacturer for evaluation.Procedural orppost procedural images were not provided.Therefore, the reported event could not be confirmed.

Event Description

It was reported that during treatment of an aneurysm of the ic-paraclinoid, a fred 27 stent was deployed but the proximal part of the stent did not fully expand.Attempts to open the stent using a headway27 microcatehter and a microwire were unsuccessful and the stent was then attempted to be retrieved using a snare.However, when the stent was attempted to be retrieved into a guiding sheath at the cca while holding the stent, the stent dropped downwards in position.The stent could not be retrieved with the snare so it was pushed into the eca.A wall stent was then implanted from the ica to cca as a prophylactic measure.A fred stent of a different size was then implanted at the horizontal part of ic.The procedure was successfully completed.It was reported that "there has been no health problem to the patient since the procedure.".

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12636730
• MDR Text Key: 277752772
• Report Number: 2032493-2021-00412
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121890
• UDI-Public: (01)04987892121890(11)200423(17)230331(10)200423561
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: MV-F501927
• Device Lot Number: 200423561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2021
• 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): Required Intervention