Cobra PzF 170-03-25015Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00879397000678), received between Dec 26, 2018 and May 6, 2020 — classified as 1 injury, 3 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.

• MalfunctionMay 6, 2020Device Dislodged or Dislocated; Material Twisted/Bent; Activation Failure; Device Dislodged or Dislocated; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A 2.5X15MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED TO A LESION IN AN UNSPECIFIED VESSEL. AN ATTEMPT WAS MADE TO DEPLOY THE STENT, BUT THE STENT DID NOT DEPLOY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS RECEIVED WITH ITS BALLOON PARTIALLY INFLATED AND WITHOUT ITS STENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SITE; THE SITE INDICATED THAT WHILE THEY WERE UNAWARE OF ANY STENT DISLODGEMENT, THEY HAD CONFIRMED UNDER FLUOROSCOPY THAT THERE WAS NO STENT DISLODGED IN THE PATIENT AND THEY DO NOT RECOLLECT ANY OCCURRENCE OF INTENTIONAL MANIPULATION OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10031050 ↗
• InjuryMar 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, A MALE PATIENT PRESENTED WITH CHEST PAIN. A LESION RIGHT CORONARY ARTERY (RCA) WAS IDENTIFIED. A GUIDE WIRE WAS ADVANCED, FOLLOWED BY SEATING OF A GUIDE CATHETER IN THE RCA. WHILE ADVANCING A 2.5X15MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM THROUGH THE GUIDE CATHETER, THE STENT DISLODGED INSIDE OF THE GUIDE CATHETER. WITH THE GUIDE WIRE REMAINING IN POSITION, THE PHYSICIAN CAREFULLY ATTEMPTED TO REMOVE THE STENT SYSTEM AND GUIDE CATHETER FROM THE ANATOMY AS A SINGLE UNIT; WHILE REMOVING THEM THROUGH THE SHEATH, THE STENT EMBOLIZED OUT OF THE GUIDE CATHETER AND ONTO THE GUIDE WIRE. THE STENT WAS SUCCESSFULLY SNARED AND THERE WERE NO ADVERSE PATIENT SEQUELAE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8425453 ↗
• MalfunctionJan 18, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ON (B)(6) 2018, PRIOR TO REMOVING A 4.0X18MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM FROM ITS DISPENSER COIL PACKAGING, THE COIL WAS FLUSHED WITH HEPARINIZED SALINE. THE STENT SYSTEM WAS THEN PULLED OUT OF THE COIL WITHOUT DIFFICULTY. NEGATIVE PRESSURE, WITH CONTRAST, WAS THEN DRAWN USING AN INDEFLATOR INFLATION DEVICE, FOLLOWED BY REMOVAL OF THE PROTECTIVE STENT SHEATH, WITHOUT ISSUE. THE STENT SYSTEM WAS THEN ADVANCED IN THE PATIENT VIA RADIAL ACCESS; ONCE CROSSING THE LESION, AN ATTEMPT WAS MADE TO DEPLOY THE STENT, BUT IT WAS DISCOVERED THAT THE STENT HAD DISLODGED ONTO THE PROXIMAL SHAFT AT SOME POINT DURING ADVANCEMENT. ALL DEVICES (STENT, DELIVERY SYSTEM, GUIDE CATHETER, AND GUIDE WIRE) WERE THEN WITHDRAWN AS A SINGLE UNIT. THE FLARED STENT ENDS WERE THEN NOTED AND, REPORTEDLY, THE FLARED ENDS LIKELY OCCURRED DURING ADVANCEMENT THEN WITHDRAWAL. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS SUCCESSFULLY TREATED WITH A DRUG-ELUTING STENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261395 ↗
• MalfunctionDec 26, 2018Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ON (B)(6) 2018, WHILE PREPPING A 2.5X15MM, COBRA PZF NANOCOATED CORONARY STENT SYSTEM FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE STENT CAME OFF OF THE BALLOON AND STENT DAMAGE WAS NOTED (THE STENT STRUTS APPEARED TO BE MANGLED). THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Patient Involvement

  MAUDE report 8197438 ↗