Cobra PzF 170-03-27515Recalls & 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 00879397000739), received between Feb 2, 2018 and Feb 2, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Angina1
- Thrombosis1
- Ventricular Tachycardia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) YEAR-OLD MALE WITH PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE STATUS POST CORONARY ARTERY BY-PASS GRAFT (CABG), PREVIOUS PERCUTANEOUS CORONARY INTERVENTION (PCI), UNSTABLE ANGINA ON MAXIMIZED MEDICAL THERAPY WITH ABNORMAL STRESS TEST SHOWING APICAL DEFECT PRESENTED FOR PCI. CORONARY ANGIOGRAPHY FOR FURTHER EVALUATION, PERFORMED ON (B)(6) 2017, SHOWED LEFT ANTERIOR DESCENDING ARTERY (LAD) OSTIAL 80% IN STENT (NOT A COBRA STENT) STENOSIS, 100 % OCCLUDED DISTAL LAD, 100 %OCCLUDED 3RD OBTUSE MARGINAL (OM), AND SIGNIFICANT STENOSIS (90%) IN BOTH PROXIMAL AND MID CIRCUMFLEX. THE PATIENT ENROLLED IN COBRA TRIAL, AND HAD SUCCESSFUL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WITH (3.0X15MM) COBRA PZF STENT PLACED IN THE PROXIMAL CIRCUMFLEX (PCX) WITH POST-DILATION BALLOON ANGIOPLASTY, AND (2.75X15MM) COBRA PZF STENT PLACED IN THE MID CIRCUMFLEX WITH POST-DILATION BALLOON ANGIOPLASTY. ALSO, SUCCESSFUL PTCA TO OSTIAL LAD USING HIGH PRESSURE BALLOON WAS PERFORMED. NO RESIDUAL STENOSIS WAS LEFT, AND TIMI FLOW 3 WAS NOTED. THE PATIENT EXPERIENCE WITH CHEST PAIN WITH VENTRICULAR TACHYCARDIA, WHILE RECOVERING IN THE HOLDING AREA. EMERGENT SELECTIVE CORONARY ANGIOGRAPHY WAS P
Patient problems: Angina; Thrombosis; Ventricular Tachycardia
MAUDE report 7236270 ↗
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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