Cobra PzF 170-03-35018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00879397000869), received between Oct 15, 2019 and Feb 27, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN (B)(6) YEAR-OLD MALE WITH MEDICAL HISTORY CORONARY ARTERY DISEASE, DIABETES MELLITUS TYPE II, HYPERTENSION, DYSLIPIDEMIA, PRIOR CORONARY ARTERY BYPASS GRAFT (CABG) IN 2018, PRIOR PERCUTANEOUS CORONARY INTERVENTION (PCI) IN 2008, AND ATRIAL FIBRILLATION PRESENTED WITH STABLE ANGINA. THE PATIENT ENROLLED IN COBRA TRIAL ON 12 AUGUST 2019. ANGIOGRAPHY SHOWED A SIGNIFICANT LESION IN THE PROXIMAL LEFT ANTERIOR CIRCUMFLEX (LCX) CORONARY ARTERY. PCI WAS PERFORMED, WITHOUT PRE-DILATION, VIA DEPLOYMENT OF FOUR COBRA PZF¿ NANOCOATED STENTS (3 EACH OF 3.5X15MM SIZE, AND 3.5X18MM), FOLLOWED BY POST-DILATATION. THE PROCEDURE WAS CONCLUDED WITHOUT ISSUE AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. STARTING (B)(6) 2019, PATIENT WAS FEELING INTERMITTENT CHEST PAIN FOR A WEEK, RADIATING DOWN LEFT ARM EVEN AT REST. PATIENT VISITED CARDIOLOGIST WHO SENT THEM TO THE HOSPITAL DUE TO EKG CHANGES: ST DEPRESSIONS V2-V4. ELIQUIS WAS HELD FOR AN ANGIOGRAM WHICH RESULTED IN STENOSIS IN THE LEFT MAIN AND PROXIMAL LCX. DRUG ELUTING STENTS WERE IMPLANTED INTO THE LEFT MAIN AND PLCX WHERE THE PREVIOUS COBRA STENT WAS IMPLANTED. THE PATIENT WAS LOADED WITH 600MG PLAVIX UPON ARRIVAL TO THE HOSPITAL. PATIENT

  Patient problems: Stenosis

  MAUDE report 9764891 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 69-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) AND HYPERTENSION PRESENTED ON 22-AUG-2019 FOR PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR TREATMENT OF A HEAVILY CALCIFIED LESION IN THE MODERATELY TORTUOUS LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. ACCESS WAS GAINED VIA RIGHT RADIAL APPROACH. THE PHYSICIAN HAD DIFFICULTY ENGAGING THE LEFT CORONARY ARTERY TO PERFORM THE ANGIOPLASTY, DUE TO THE MODERATE VESSEL TORTUOSITY, BUT PRE-DILATION WAS ULTIMATELY PERFORMED. A 3.5 X 18MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED TO THE MID/DISTAL PORTION OF THE LCX AND THE STENT WAS DEPLOYED JUST BEYOND THE HEAVILY CALCIFIED PORTION OF THE VESSEL. SEVERAL INFLATIONS WERE PERFORMED THEN THE BALLOON CATHETER WAS WITHDRAWN. UPON WITHDRAWAL OF THE COBRA DELIVERY SYSTEM, TIMI 0 FLOW WAS NOTED; THE PHYSICIAN SUSPECTS CAUSE OF TIMI 0 FLOW WAS VASOSPASM. A 3.5 X 12MM BALLOON CATHETER WAS ADVANCED TO INFLATE THE LESION JUST PROXIMAL TO THE IMPLANTED COBRA STENT. AFTER THE VESSEL REGAINED TIMI 3 FLOW, THE PHYSICIAN ELECTED TO USE A 4.00 X 24MM COBRA PZF¿ STENT SYSTEM FOR THE PROXIMAL/MID PORTION OF THE LCX TO TREAT THE REMAINING UNCOVERED PORTION OF T

  Patient problems: Ischemia; Vasoconstriction

  MAUDE report 9191677 ↗