Cobra PzF 170-03-25018Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00879397000685), received between Dec 26, 2018 and Jul 15, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  ON (B)(6) 2019, PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) OF A LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.5X18MM COBRA PZF CORONARY STENT SYSTEM WAS ADVANCED BUT WAS UNABLE TO CROSS. ANOTHER SMALLER UNSPECIFIED STENT CROSSED AND WAS DEPLOYED IN THE LESION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. WHILE THE STENT WAS RECEIVED CRIMPED TO THE BALLOON, AFTER DISINFECTING THE DEVICE, THE STENT CAME OFF THE BALLOON WHILE MANIPULATING THE DEVICE DURING ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8789024 ↗
• MalfunctionJan 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE FOR TREATMENT OF AN UNSPECIFIED CORONARY VESSEL, A 2.5X18MM, COBRA PZF NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED THEN WAS WITHDRAWN, UNDEPLOYED, FOR AN UNSPECIFIED REASON. PRIOR TO ATTEMPTING RE-INSERTION OF THE STENT SYSTEM, THE PHYSICIAN NOTED THAT THE STENT HAD DISLODGED FROM THE STENT DELIVERY SYSTEM, OUTSIDE OF PATIENT ANATOMY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8208138 ↗
• MalfunctionDec 26, 2018Unstable; Failure to Advance; Unstable; Failure to Advance

  ON (B)(6) 2018, A 79-YEAR-OLD FEMALE PATIENT PRESENTED WITH A NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI). PERCUTANEOUS CORONARY INTERVENTION (PCI) OF A CHRONIC TOTAL OCCLUSION (CTO) IN THE MODERATELY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY (LCX) WAS PERFORMED. DURING THE PCI, THE CTO WAS PRE-DILATED, THEN A 2.5X18MM COBRA PZF CORONARY STENT SYSTEM WAS ADVANCED VIA RIGHT RADIAL ACCESS BUT WAS UNABLE TO CROSS DUE TO PATIENT ANATOMY (CTO). THE PATIENT WAS ALTERNATIVELY TREATED VIA BALLOON ANGIOPLASTY (POBA). THE PATIENT WAS SCHEDULED TO RETURN FOR FUTURE PCI. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO SIGNIFICANT DELAY. THE DEVICE WAS RECEIVED BY CELONOVA BIOSCIENCES IN THE FOLLOWING CONDITION: THE STENT WAS SHIFTED DISTALLY AND WAS LOOSE ON THE BALLOON, BUT THE STENT REMAINED BETWEEN THE BALLOON MARKER BANDS AND WAS NOT ABLE TO BE PUSHED PAST THE DISTAL BALLOON MARKER. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8197791 ↗