V-Trak 7118-1139-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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777023971), received between Oct 27, 2022 and Oct 27, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Premature Separation” (1 report).
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.
Most reported problems
Device problems
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2022Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING A STENT-ASSISTED COILING PROCEDURES TO TREAT A 13.5MM BASILAR TIP ANEURYSM, THE PHYSICIAN HAD PLACED 2 NON-MICROVENTION STENTS ONE EACH IN BOTH PCAS. THREE HYDROFRAME COILS WERE THEN PLACED. THE FOURTH COIL WAS GOING INTO THE COIL MASS AND PRIMARILY FILLING THE ANTERIOR PORTION OF THE ANEURYSM. THE PHYSICIAN BEGAN TO PULL THE COIL BACK OUT AND WAS MET WITH RESISTANCE AND THE COIL PREMATURELY DETACHED AS THE BELIEF THAT IT WAS CAUGHT IN THE COIL MASS. ABOUT 20MM OF COIL WAS PROTRUDING ALL OF THE WAY DOWN INTO THE VERTEBRAL ARTERY. A SNARE WAS NOT AVAILABLE TO REMOVE THE COIL AND PHYSICIAN USED 4 STENTS TO TACK DOWN THE STRETCHED COIL. AT THE VERTEBRAL ARTERY THE DIAMETER OF THE VESSEL WAS OVER 5.5MM AND THE MOST PROXIMAL PORTION OF THE COIL NEEDED TO BE TACKED DOWN WITH A LARGER CAROTID STENT. DUE TO TORTUOSITY, IT WAS UNABLE TO GET THE CAROTID STENT IN PLACE AND ABOUT 5MM OF COIL REMAINED FREE FLOATING IN THE VERTEBRAL ARTERY AND THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS DISCHARGED AND IS IN STABLE CONDITION AND IS ON DAPT PER STANDARD PROTOCOL. NO ADDITIONAL INTERVENTIONS PLANNED OR NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15685829 ↗
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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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