V-Trak 7118-0827-A2Recalls & reported problems
Microvention, Inc. · HydroFrame 18 Advanced · Class 2 · Implant
All models of V-Trak (75)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777023940), received between Nov 9, 2024 and Nov 15, 2024 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Aneurysm2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH A RAGE CLINICAL STUDY, THE PATIENT HAD A MILD COMPACTION WITH REMNANT NECK POST PROCEDURE. THE ANEURYSM LOCATION WAS POSTERIOR COMMUNICATION (PCOM) ON THE LEFT SIDE. THE HEIGHT IS 7.8MM, WIDTH 8.3MM, DEPTH 7.7 MM, NECK SIZE 5.0 MM AND DOME TO NECK RATIO: 1. 66 MM. THE PATIENT UNDERWENT RETREATMENT WITH USING A FLOW DIVERTER. THE PATIENT HAD A FOLLOW-UP VISIT ON (B)(6) 2022. THERE WERE NO ADDITIONAL ADVERSE EVENTS REPORTED. MRS SCORE WAS 0. PATIENT EXITED THE STUDY ON (B)(6) 2023.
Patient problems: Aneurysm
MAUDE report 20698707 ↗InjuryNov 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH A RAGE CLINICAL STUDY, THE PATIENT HAD A MILD COMPACTION WITH REMNANT NECK POST PROCEDURE. THE ANEURYSM LOCATION WAS POSTERIOR COMMUNICATION (PCOM) ON THE LEFT SIDE. THE HEIGHT IS 7.8MM, WIDTH 8.3MM, DEPTH 7.7 MM, NECK SIZE 5.0 MM AND DOME TO NECK RATIO: 1. 66 MM. THE PATIENT UNDERWENT RETREATMENT WITH USING A FLOW DIVERTER. THE PATIENT HAD A FOLLOW-UP VISIT ON (B)(6) 2022. THERE WERE NO ADDITIONAL ADVERSE EVENTS REPORTED. MRS SCORE WAS 0. PATIENT EXITED THE STUDY ON (B)(6) 2023.
Patient problems: Aneurysm
MAUDE report 20647746 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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