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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 3.5X17X11 STENT

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MICROVENTION, INC. FRED 3.5X17X11 STENT Back to Search Results
Model Number 45-750617
Device Problem Difficult to Fold, Unfold or Collapse (1254)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2020
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 not returned to the manufacturer for evaluation. The root cause cannot be determined.
 
Event Description
It was reported that the (b)(6) did not open spontaneously during deployment. The microcatheter was used to manipulate the stent to achieve a satisfactory result. At the end of the procedure, the fred was correctly expanded, the parent artery was patent without stenosis, and the fred covered the aneurysm neck as planned. The patient was discharged the next day with an mrs
=
2, which was unchanged from the patient's mrs score of 2 upon admission. There was no reported patient injury.
 
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Brand NameFRED 3.5X17X11
Type of DeviceSTENT
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo, ca
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, ca 
MDR Report Key9742502
MDR Text Key188689621
Report Number2032493-2020-00043
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2021
Device Model Number45-750617
Device Lot Number18121356W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/21/2020 Patient Sequence Number: 1
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