HyperSoft 3D Advanced 8410-0102Recalls & 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
- 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 00811425027929), received between Apr 19, 2018 and Apr 19, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
Patient problems
- Hemorrhage, Subarachnoid1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2018Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, AN ANEURYSM RUPTURE OCCURRED WHILE USING A NON-MICROVENTION COIL. THE COIL WAS LEFT IN PLACE TO TAMPONADE THE BLEED. AN ATTEMPT WAS THEN MADE TO PLACE THE HYDROSOFT 3D COIL; HOWEVER, THE COIL STRETCHED DURING POSITIONING IN THE ANEURYSM. DURING AN ATTEMPT TO RETRIEVE THE COIL, IT PULLED OUT THE FIRST COIL THAT HAD BEEN IMPLANTED, CAUSING THE BLEEDING TO START AGAIN AND WORSEN. THE COILS WERE REMOVED ALONG WITH THE MICROCATHETER, WHICH ALLOWED THE PATIENT TO BLEED INTO THE SUBARACHNOID SPACE FOR 2-3 MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER COMPANY'S PRODUCTS. THE PATIENT IS REPORTED TO BE IN A MEDICALLY INDUCED COMA, AND WAS IN CRITICAL CONDITION.
Patient problems: Hemorrhage, Subarachnoid
MAUDE report 7443494 ↗
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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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