Cobra PzF 170-03-25012Recalls & 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 00879397000661), received between Jan 4, 2019 and Jan 4, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Failure to Advance1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 4, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated
ON (B)(6) 2018, (B)(6)-YEAR-OLD PATIENT WITH CORONARY ARTERY DISEASE WITH VESSEL CALCIFICATION AND TORTUOSITY PRESENTED WITH A NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A HEAVILY CALCIFIED LESION IN THE TORTUOUS OBTUSE MARGINAL (OM) WAS IDENTIFIED. AFTER PRE-DILATING THE VESSEL, A 2.75X12MM COBRA STENT WAS DEPLOYED IN THE PROXIMAL TO MID OM WITHOUT ISSUE. AN ATTEMPT WAS THEN MADE TO CROSS THIS STENT VIA RIGHT RADIAL ACCESS FOR TREATMENT OF THE DISTAL OM AS FOLLOWS: A 2.5X12MM COBRA PZF NANOCOATED STENT SYSTEM WAS ADVANCED OVER A WHISPER ES 190CM GUIDE WIRE, AND THROUGH A 5F AL1 LBT GUIDE CATHETER, BUT, DESPITE PUSHING THE DEVICE AGAINST RESISTANCE, IT WAS UNABLE TO CROSS THE 1ST STENT DUE TO TORTUOSITY AND SEVERE CALCIFICATION. WHILE RETRACTING THE STENT SYSTEM, THE STENT STRIPPED (DISLODGED) OFF OF THE BALLOON. ATTEMPTS WERE MADE TO SNARE THE STENT USING A 2ND GUIDE WIRE AND A BALLOON, BUT IT WAS UNABLE TO BE RETRIEVED AND IT REMAINS IN THE ANATOMY. AS THE TARGET LESION WAS PRE-DILATED, THE PHYSICIAN FELT THAT THIS TREATMENT WAS SUFFICIENT AND LEFT THE DISTAL OM LESION AS IS. THERE WERE NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 8217769 ↗
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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