Cobra PzF 170-03-40018Recalls & reported problems
Celonova Biosciences, Inc. · NanoCoated Coronary Stent System · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00879397000920), received between Feb 22, 2018 and Dec 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Failure to Advance2
- Device Dislodged or Dislocated1
- Material Deformation1
- Unstable1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2019Unstable; Failure to Advance; Material Deformation; Unstable; Failure to Advance; Material Deformation
ON (B)(6) 2019, A (B)(6)-YEAR OLD FEMALE PATIENT WITH ST-ELEVATED MYOCARDIAL INFARCTION (STEMI) PRESENTED FOR PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) OF AN UNKNOWN VESSEL. AFTER PRE-DILATATION, A 4.0X18MM COBRA PZF¿ CORONARY STENT SYSTEM WAS ADVANCED TOWARD THE TARGET LESION BUT UNABLE TO CROSS. A 3.5 X 16MM SYNERGY STENT WAS THEN PLACED AT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS RECEIVED 22-NOV-2019 WITH EXTENSIVE DAMAGE TO THE STENT, WITH THE STENT WAS STRETCHED AND SHIFTED DISTALLY PAST THE DISTAL TIP OF THE DELIVERY SYSTEM, BUT NOT COMPLETELY DISLODGED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9473188 ↗MalfunctionFeb 22, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated
A (B)(6) YEAR OLD MALE PATIENT PRESENTED WITH LESIONS IN THE PROXIMAL AND DISTAL RIGHT CORONARY ARTERY (RCA). AN ATTEMPT WAS MADE TO CROSS THE PROXIMAL LESION WITH A 4.0X18MM COBRA PZF STENT DELIVERY SYSTEM, BUT IT WAS UNABLE TO CROSS DUE TO VESSEL CALCIFICATION. DURING WITHDRAWAL OF THE STENT SYSTEM THROUGH THE TOUHY VALVE, THE STENT CAME OFF OF THE BALLOON. THE DISLODGED STENT WAS RETRIEVED FROM INSIDE OF THE TOUHY. THE PATIENT WAS SUCCESSFULLY TREATED WITH A NEW 4.0X18MM COBRA. THERE WERE NO ADVERSE PATIENT EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7289082 ↗
Other Stent, Coronary devices
- WALLSTENT® Endoprosthesis H965403130Boston Scientific Corporation · STENT, CORONARY35 reports
- WALLSTENT® Endoprosthesis H965402130Boston Scientific Corporation · STENT, CORONARY23 reports
- Tryton Side Branch Stent T5-2530-191-USTryton Medical, Inc. · Stent, Coronary1 death22 reports
- WALLSTENT® Endoprosthesis H965403330Boston Scientific Corporation · STENT, CORONARY21 reports
- WALLSTENT® Endoprosthesis H965403320Boston Scientific Corporation · STENT, CORONARY10 reports
- WALLSTENT® Endoprosthesis H965403120Boston Scientific Corporation · STENT, CORONARY9 reports
- Tryton Side Branch Stent T5-3035-151-USTryton Medical, Inc. · Stent, Coronary2 deaths7 reports
- MULTI-LINK VISION 1007850-15Abbott Vascular Inc. · STENT, CORONARY7 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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