Cobra PzF 170-03-30012Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00879397000784), received between Sep 6, 2019 and Sep 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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 Deformation1
- Unstable1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2019Unstable; Material Deformation; Unstable; Material Deformation
ON (B)(6) 2019, A PATIENT PRESENTED FOR PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) IN AN UNSPECIFIED VESSEL. A 3.0X12MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS PREPPED WITHOUT ISSUE. UPON ENTRY INTO THE GUIDE CATHETER, THE PHYSICIAN NOTED THAT THE STENT WAS DAMAGED / BENT. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER UNSPECIFIED DEVICE WAS USED TO TREAT THE TARGET LESION. THE COMPLAINT DEVICE WAS RECEIVED IN THE FOLLOWING CONDITION: THE STENT WAS SHIFTED DISTALLY, OVER THE DISTAL BALLOON MARKER. BLOOD WAS NOTED INSIDE OF THE GUIDE WIRE NOTCH & BALLOON FOLDS; GUIDE WIRE NOTCH DAMAGE WAS OBSERVED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS PREPPED AND HANDLED WITH BLOODY GLOVES, WAS INTRODUCED OVER GUIDE WIRE, AND INTO HEMOSTATIC VALVE, BUT WAS ULTIMATELY NOT INTRODUCED INTO THE PATIENT SINCE THE STENT DAMAGE (BENT STRUTS AND SHIFTED STENT) WAS NOTED DURING ENTRY INTO VALVE AND GUIDE CATHETER, THEN WAS WITHDRAWN DUE TO THE NOTED DAMAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8970106 ↗
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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