Cobra PzF 170-03-40030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00879397000944), received between Feb 6, 2018 and Oct 10, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2019Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  A 60-YEAR-OLD MALE PATIENT PRESENTED ON (B)(6) 2019 FOR PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI). ANGIOGRAPHY SHOWED A MODERATELY CALCIFIED LESION IN THE SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY (MRCA) WITH A PREVIOUSLY IMPLANTED STENT IN THE PROXIMAL SEGMENT. THE PHYSICIAN GAINED ARTERIAL ACCESS VIA THE RIGHT RADIAL ARTERY. AFTER PRE-DILATING THE LESION WITH A 3.5X15MM SEMI-COMPLIANT BALLOON, AN ATTEMPT TO CROSS WAS MADE WITH A 4.0X30MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM, BUT THIS DEVICE WAS UNABLE TO CROSS THE LESION DUE TO PATIENT ANATOMY. DURING WITHDRAWAL, RESISTANCE WAS FELT AGAINST THE ANATOMY, AND THE STENT DISLODGED IN THE PROXIMAL PART OF THE RCA. THE DISLODGED STENT WAS SNARED AND RETRIEVED FROM THE VESSEL. A NEW, SMALLER STENT (3.5X30MM COBRA PZF¿) WAS DEPLOYED IN THE MRCA. THERE WERE NO ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, USER FACILITY MEDWATCH REPORT WAS RECEIVED, AND STATES THE FOLLOWING: "DESCRIBE THE EVENT OR PROBLEM: PHYSICIAN INSERTED A STENT INTO A PATIENT'S CORONARY ARTERY. AS THE PHYSICIAN WAS TAKING THE DEPLOYMENT SYSTEM OUT, IT WAS THEN NOTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9174766 ↗
• MalfunctionAug 20, 2019Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  A (B)(6)-YEAR-OLD MALE PATIENT PRESENTED WITH ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI); TREATMENT OF AN UNSPECIFIED VESSEL VIA PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS SCHEDULED. ON (B)(6) 2019, AFTER UNPACKAGING A 4.0X30MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM, THE STENT APPEARED TO BE SHIFTED PROXIMALLY ON THE BALLOON, BUT WAS NOT DISLODGED. THE DEVICE WAS NOT USED IN THE PATIENT; IT WAS RE-PACKAGED BY THE SITE FOR RETURN. CELONOVA BIOSCIENCES RETURNED GOODS LAB RECEIVED THE DEVICE WITHOUT ITS STENT. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE SITE THOUGHT THE STENT HAD BEEN REPACKAGED WITH ITS DELIVERY SYSTEM AND, WHILE THE CURRENT STENT LOCATION IS NOT KNOWN, THE DEVICE WAS NEVER USED IN THE PATIENT. NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910644 ↗
• MalfunctionOct 3, 2018Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  ON (B)(6) 2018, THE PATIENT PRESENTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN THE NON-TORTUOUS MID RIGHT CORONARY ARTERY (RCA). AFTER PRE-DILATING THE LESION, A 4.0X30MM COBRA PZF NANOCOATED STENT SYSTEM WAS ADVANCED TO THE LESION WITHOUT DIFFICULTY, HOWEVER, THE PHYSICIAN REPORTED RESISTANCE IN THE MID SEGMENT OF THE STENT WHEN THE GUIDE WIRE PASSED THROUGH IT. IN ADDITION, THE PHYSICIAN HAD ALSO DECIDED TO TREAT A DISTAL LESION; THUS, THE PHYSICIAN DECIDED NOT TO USE THIS STENT SYSTEM AND IT WAS SUBSEQUENTLY WITHDRAWN WITHOUT DIFFICULTY. THE PHYSICIAN NOTICED WHAT APPEARED TO BE A POSSIBLE PROTRUDING DISTAL STRUT. A 3.5X24MM COBRA STENT WAS USED TO TREAT DISTAL SEGMENT AND A 4.0X24MM COBRA STENT WAS DEPLOYED TO MID RCA SEGMENT. THE PATIENT WAS NEVER AT RISK AND THERE WAS A GREAT OUTCOME. DURING START OF ANALYSIS OF THE RECEIVED DEVICE, IT WAS NOTED ON 04-SEP-2018 BY CELONOVA BIOSCIENCES THAT THE STENT WAS SHIFTED DISTALLY OVER THE BALLOON, PAST THE DISTAL TIP (PARTIAL DISLODGEMENT). ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN CONFIRMED THAT THE PARTIAL DISLODGEMENT VISUALIZED BY CELONOVA IS WHAT THE PHYSICIAN WAS REFERRING TO WHEN REPORTING THE PROTRUDING DISTAL STRU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930041 ↗
• InjuryFeb 6, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  ON (B)(6) 2017, DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO IMPLANT A 4.0X30MM COBRA PZF STENT IN LEFT CIRCUMFLEX (LCX), PRE-DILATATION WITH A 2.5X15MM APEX BALLOON WAS PERFORMED. THEN, DURING ADVANCEMENT OF THE COBRA PZF STENT DELIVERY SYSTEM TO THE LCX LESION, IT WAS UNABLE TO CROSS, REPORTEDLY DUE TO VESSEL TORTUOSITY AND THE STENT DISLODGED IN THE PATIENT. THE WHOLE DISLODGED STENT WAS SUCCESSFULLY RETRIEVED USING A GOOSENECK MICROSNARE MICROCATHETER. A 4.0X28MM DRUG-ELUTING STENT (DES) WAS THEN SUCCESSFULLY IMPLANTED. THERE WERE NO ADVERSE PATIENT SEQUELAE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7245812 ↗