HyperSoft 3D Advanced 8410-0358Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811425028070), received between May 3, 2016 and May 3, 2016 — classified as 1 death.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Aneurysm1
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMay 3, 2016Detachment of Device or Device Component; Detachment of Device or Device Component
THE PATIENT PRESENTED ALLEGEDLY UNCONSCIOUS WITH A RUPTURED P COMM ANEURYSM. THE PATIENT HAD A VENTRICULOPERITONEAL SHUNT PREVIOUSLY IMPLANTED TO RELIEVE INTRACRANIAL PRESSURE. THE PHYSICIAN TREATMENT PLAN WAS TO PERFORM AN EMBOLIZATION OF THE ANEURYSM. DURING THE TREATMENT PROCEDURE OF THE P COMM ANEURYSM, IT WAS REPORTED TO THE MANUFACTURER THAT THE DELIVERY OF AN EMBOLIZATION COIL INTO THE ANEURYSM WAS UNEVENTFUL, BUT THAT THE DETACHMENT OF THE EMBOLIZATION COIL FROM ITS DELIVERY SYSTEM ENCOUNTERED DIFFICULTIES. ATTEMPTS MADE TO RETRIEVE THE EMBOLIZATION COIL FROM THE ANEURYSM APPARENTLY CAUSED THE EMBOLIZATION COIL TO STRETCH AT SOME POINT DURING THE MANIPULATIONS. SEVERAL MEDICAL DEVICES WERE USED IN THE PROCEDURE, INCLUDING AN ASPIRATION CATHETER, A DISTAL ACCESS CATHETER, A GUIDEWIRE, AND A CORONARY BALLOON CATHETER. DURING THESE MANIPULATIONS, IT WAS DETERMINED THAT THE COIL HAD DETACHED FROM ITS DELIVERY PUSHER BUT THAT A PORTION OF THE COIL REMAINED IN THE CATHETER. A CORONARY BALLOON (MFG. UNKNOWN) WAS USED TO ASSIST IN RETRIEVAL. THE CATHETER, THE BALLOON AND PORTION OF THE COIL WERE VISUALIZED UNTIL THE SYSTEM HAD EXITED THE GUIDE CATHETER. IMAGES CONFIRMED THAT MOST O
Patient problems: Aneurysm; Death
MAUDE report 5627500 ↗
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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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