Cobra PzF 170-03-25030Recalls & reported problems
Celonova Biosciences, Inc. · NanoCoated Coronary Stent System · Class 3 · Implant
Data updated Oct 16, 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 00879397000708), received between May 17, 2018 and May 17, 2018 — 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 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Difficult to Remove1
- Failure to Advance1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2018Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated
ON (B)(6) 2018, A (B)(6) YEAR OLD MALE PATIENT PRESENTED WITH TWO-VESSEL DISEASE WITH CALCIFICATION. DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR TREATMENT OF PROXIMAL AND DISTAL LESIONS IN THE TORTUOUS RIGHT CORONARY ARTERY (RCA), A 2.5X30MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED PAST THE MID RCA WITH DIFFICULTY CROSSING THE MID RCA AT THE BEND. AFTER CROSSING THE MID RCA, NUMEROUS ATTEMPTS WERE MADE TO CROSS THE DISTAL RCA LESION, BUT THE DEVICE WAS UNABLE TO CROSS, DESPITE PUSHING AGAINST RESISTANCE. THE PHYSICIAN THEN DECIDED TO WITHDRAW THE STENT SYSTEM TO ALTERNATIVELY TREAT THE LESIONS WITH TWO SMALLER STENTS, HOWEVER, UPON WITHDRAWAL INTO THE 6FR GUIDELINER CATHETER, RESISTANCE WAS FELT AGAINST THE GUIDELINER AND THE STENT WAS STRIPPED OFF OF THE BALLOON AT THE GUIDELINER. AFTER APPROXIMATELY 30 MINUTES, THE DISLODGED STENT WAS SNARED USING AN EN SNARE DEVICE. TREATMENT OF THE TARGET LESIONS WAS ABORTED. THE PATIENT WAS STABLE AT THE CONCLUSION OF THE PROCEDURE WITH NO REPORTED ADVERSE SEQUELAE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7524467 ↗
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
- PALMAZ Balloon Expandable Stent P308Cordis US Corp. · STENT, CORONARY7 reports
- Cobra PzF 170-03-35024Celonova Biosciences, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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