Cobra PzF 170-03-35030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00879397000883), received between Aug 20, 2019 and Sep 11, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2020Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation

  ON (B)(6) 2020, A PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED USING 3.5X30 COBRA PZF NANOCOATED CORONARY STENT SYSTEM. THE PHYSICIAN ADVANCED THE COBRA STENT SYSTEM TO THE TARGET LESION ; WHEN INFLATING THE STENT SYSTEM, THE PHYSICIAN DISCOVERED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT WAS FOUND DAMAGED/DISLODGED, STUCK INSIDE OF ITS PROTECTIVE SHEATH PACKAGING (OCCURRED OUTSIDE OF PATIENT PRIOR TO INSERTION). THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. REPORTEDLY, THE STENT HAD NOT BEEN INSPECTED PRIOR TO INTRODUCING DELIVERY SYSTEM INTO PATIENT. THE TARGET LESION WAS TREATED SUCCESSFULLY WITH ANOTHER COBRA STENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10522414 ↗
• MalfunctionAug 11, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ON (B)(6) 2020, WHILE UNPACKAGING A 3.5X30 COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM FOR A PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT DAMAGE WAS NOTED. ANOTHER 3.5X30 COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS UNPACKAGED; STENT DAMAGE WAS ALSO OBSERVED ON THIS DEVICE AND THE STENT DISLODGED FROM THE BALLOON PRIOR TO ENTERING THE PATIENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393552 ↗
• MalfunctionMar 2, 2020Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  DURING PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR TREATMENT OF A LESION IN AN UNSPECIFIED CORONARY VESSEL ON (B)(6) 2020, A 3.5X30MM COBRA PZF NANOCOATED STENT SYSTEM BECAME STUCK INSIDE OF A GUIDELINER (SIZE UNSPECIFIED) DURING ADVANCEMENT AND THE STENT DISLODGED IN THE GUIDELINER. THE GUIDELINER WITH DISLODGED STENT WERE WITHDRAWN AS A SINGLE UNIT AND WERE DISCARDED BY SITE. ANOTHER SAME SIZE COBRA PZF¿ STENT WAS ADVANCED IN SAME SIZE GUIDELINER WITHOUT DIFFICULTY; THE STENT WAS DEPLOYED IN THE TARGET LESION WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED DUE TO HOSPITAL PRIVACY POLICY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9775562 ↗
• MalfunctionNov 18, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN, RESULTING IN THE FOLLOWING REVISED NARRATIVE: A FEMALE PATIENT PRESENTED FOR PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI). ANGIOGRAPHY PERFORMED ON 21-OCT-2019 SHOWED A SEVERELY CALCIFIED LESION IN THE OSTIAL RIGHT CORONARY ARTERY (RCA) AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PHYSICIAN GAINED ARTERIAL ACCESS VIA THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 4.0X30MM COBRA PZF¿ NANOCOATED CORONARY STENT WAS ADVANCED AND DEPLOYED IN THE PROXIMAL LAD WITHOUT ISSUE. THE RCA LESION WAS PREPPED VIA ATHERECTOMY. AN ATTEMPT WAS THEN MADE TO CROSS THE CALCIFIED OSTIAL RCA LESION WITH TWO COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEMS (3.5X30MM THEN A 3.5X24MM), BUT EACH STENT SYSTEM WAS UNABLE TO CROSS DUE TO THE SEVERE CALCIFICATION. AFTER CROSSING ATTEMPT, EACH STENT DISLODGED IN THE HEMOSTATIC VALVE AFTER RETRACTION THROUGH THE 7F GUIDE CATHETER. IN EACH OCCURRENCE, THE STENT WAS RETRIEVED FROM THE HEMOSTATIC VALVE WITHOUT INJURY TO PATIENT. A 3.5X16MM DRUG-ELUTING STENT ULTIMATELY CROSSED AND WAS DEPLOYED IN THE RCA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335740 ↗
• MalfunctionAug 21, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN (B)(6) YEAR OLD MALE WITH MULTIVESSEL CORONARY ARTERY DISEASE (CAD) WITH SIGNIFICANT DISEASE IN THE OSTIAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND CHRONIC OCCLUSION OF THE MID RIGHT CORONARY ARTERY (RCA). RECENTLY TURNED DOWN FOR CORONARY ARTERY BYPASS GRAFT SURGERY (CABG), THE PROCEDURE WAS PLANNED AS A HIGH-RISK PCI INVOLVING IMPELLA PCI SUPPORT AND THE USE OF ORBITAL ATHERECTOMY, ANTICIPATING THE USE OF COBRA STENTS BECAUSE OF A PREVIOUS INTRACEREBRAL HEMORRHAGE AND THE NEED FOR SHORT-DAPT THERAPY. ON (B)(6) 2019, UPON SATISFACTION OF VESSEL PREPARATION UTILIZING ORBITAL ATHERECTOMY IN THE LAD, THE PHYSICIAN ASKED FOR A 3.5X30MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM. DURING UNPACKAGING, THE COBRA STENT SYSTEM WAS REMOVED FROM ITS DISPENSER HOOP/COIL AND THE PROTECTIVE STENT COVER WAS REMOVED FROM THE STENT WITHOUT DIFFICULTY; UPON INITIAL INSPECTION OF THE COBRA STENT,, SEVERAL LIFTED STRUTS WERE NOTED WITHIN THE MIDDLE OF THE STENT; BUT NO DAMAGE WAS NOTED TO THE PROXIMAL AND DISTAL ENDS OF THE STENT. THIS STENT WAS NOT INSERTED INTO THE BODY AND WAS TAKEN OFF THE STERILE FIELD. ANOTHER 3.5X30MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS OPENED FOR USE AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8916155 ↗
• MalfunctionAug 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED WHICH RESULTED IN THE FOLLOWING REVISED EVENT DESCRIPTION ON (B)(6) 2019 WHEN UNPACKAGING A 3.5X30MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM, THE STENT SHEATH AND STYLET WERE REMOVED WITH NO UNUSUAL RESISTANCE NOTED WHEN THE PROTECTIVE STENT SHEATH REPORTEDLY STRETCHED THE STENT, THEN ULTIMATELY PULLED THE STENT OFF OF THE BALLOON. THE DEVICE WAS NOT SOAKED OR PREPPED PRIOR TO SHEATH REMOVAL. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER SAME SIZE 3.5X30MM COBRA PZF STENT WAS USED PREPPED AND DEPLOYED IN THE PATIENT WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2019 WHEN UNPACKAGING A 3.5X30MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM, THE STENT SHEATH AND STYLET WERE REMOVED WITH NO UNUSUAL RESISTANCE NOTED WHEN THE PROTECTIVE STENT SHEATH REPORTEDLY STRETCHED THE STENT, THEN ULTIMATELY PULLED THE STENT OFF OF THE BALLOON. THE DEVICE WAS NOT SOAKED OR PREPPED PRIOR TO SHEATH REMOVAL. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER SAME SIZE 3.5X30MM COBRA PZF STENT WAS USED PREPPED AND DEPLOYED IN THE PATIENT WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Patient Involvement

  MAUDE report 8910913 ↗