Cobra PzF 170-03-27512Recalls & 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 00879397000722), received between Jul 8, 2021 and Jul 8, 2021 — 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
- Dyspnea1
- Restenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN 80-YEAR-OLD FEMALE WITH MEDICAL HISTORY OF ATRIAL FIBRILLATION ON RIVAROXABAN, TYPE 2 DIABETES MELLITUS, HYPERTENSION, DYSLIPIDEMIA, AND PERIPHERAL VASCULAR DISEASE. PRESENTED ON (B)(6) 2019 WITH EVIDENCE OF MYOCARDIAL ISCHEMIA. CORONARY ANGIOGRAPHY SHOWED GREATER THAN OR EQUAL TO 50% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. QUANTITATIVE CORONARY ANGIOGRAPHY (QCA) ANALYSIS BEFORE THE PROCEDURE REVEALED A B2 LESION WITH 56.34% STENOSIS. THE PATIENT ENROLLED IN A COBRA TRIAL. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED VIA FEMORAL ACCESS WITH PLACEMENT OF COBRA PZF¿ (2.75X12MM) STENT IN PROXIMAL LAD, FOLLOWED BY POST-DILATATION. TIMI FLOW 3 NOTED. THE PROCEDURE CONCLUDED WITHOUT COMPLICATION. POST PROCEDURE QCA ANALYSIS WAS PREFORMED AND REVEALED A 29.85% STENOSIS. THE PATIENT WAS DISCHARGED TO HOME THE FOLLOWING DAY. ON (B)(6) 2019, THE PATIENT PRESENTED WITH CHEST PAIN AND DYSPNEA. QCA BEFORE REVASCULARIZATION REVEALED 65.07% FOCAL BODY IN-STENT RESTENOSIS IN THE PROXIMAL LAD THAT EXTENDED INTO THE OSTIUM OF THE LAD. THE RESTENOSIS WAS RESOLVED THE FOLLOWING DAY VIA PCI WITH DEPLOYMENT OF A 2.75X18MM DRUG-ELUTING STENT IN THE TARGET VES
Patient problems: Angina; Dyspnea; Restenosis
MAUDE report 12137482 ↗
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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