Cobra PzF 170-03-27518Recalls & 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
- 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 00879397000746), received between Aug 20, 2020 and Aug 20, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.
Most reported problems
Device problems
- Material Rupture1
Patient problems
- Angina1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2020Material Rupture; Material Rupture
A (B)(6)-YEAR-OLD MALE PATIENT WITH MEDICAL HISTORY OF MULTI-VESSEL CORONARY ARTERY DISEASE, AND PRIOR ST-ELEVATED MYOCARDIAL INFARCTION (STEMI) TREATED VIA PERCUTANEOUS CORONARY INTERVENTION (PCI) OF NON-TARGET VESSEL, AND PANCREATIC CANCER RECENTLY DIAGNOSED WITH METASTATIS, PRESENTED (B)(6) 2020 FOR PLANNED PCI OF A SEVERELY CALCIFIED LESION IN THE VERY TORTUOUS PROXIMAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. THE PATIENT RECEIVED 7000 UNITS HEPARIN TO ACHIEVE AN ACT OF GREATER THAN 300 SECONDS. AFTER ENGAGING A 4.0 GUIDING CATHETER VIA LEFT COMMON FEMORAL ACCESS, AN ATTEMPT WAS MADE TO CROSS THE LESION WITH A WHISPER GUIDE WIRE, BUT IT WAS UNABLE TO CROSS. A FIELDER XT WIRE WAS ABLE TO CROSS. PRE-DILATATION WAS PERFORMED WITH A 2.5 X 12 BALLOON AT 14 ATMOSPHERES (ATMS) FOR 2 INFLATIONS. OF NOTE, THE PROXIMAL CIRCUMFLEX DID HAVE SOME ANEURYSMAL ECTASIA. THERE WAS EVIDENCE OF A SIGNIFICANT STENOSIS DESPITE THE BALLOON INFLATION, SUGGESTING A RING OF CALCIUM. A CUTTING BALLOON WAS UNABLE TO CROSS; A GUIDELINER SUPPORT CATHETER WAS ADVANCED THEN ADDITIONAL DILATATION WAS PERFORMED USING A 2.5X12MM NON-COMPLIANT BALLOON, INFLATED TO 20 ATMS, WITH SATISFACTORY RESULT. A 2.75X18MM COBR
Patient problems: Angina; Perforation
MAUDE report 10432966 ↗
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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