Cobra PzF 170-03-35015Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00879397000852), received between Aug 16, 2018 and Apr 27, 2020 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A (B)(6) YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE, DIABETES MELLITUS TYPE 2, HYPERTENSION, DYSLIPIDEMIA, AND EX-SMOKER PRESENTED WITH STABLE ANGINA AND ATRIAL FIBRILLATION. THE PATIENT ENROLLED IN A COBRA TRIAL. ON (B)(6) 2020, DIAGNOSTIC ANGIOGRAPHY SHOWED A 70-90% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, AND 70% STENOSIS IN MARGINAL BRANCH. AFTER PRE-DILATING THE LESION, A 3.5X15 COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS UNPACKAGED WHEN THE STENT CAME OFF OF THE BALLOON IN THE STYLET (SHEATH) PRIOR TO USE. THE DISLODGEMENT WAS NOT YET DETECTED UNTIL THE DELIVERY SYSTEM WAS ADVANCED THEN DEPLOYMENT ATTEMPT MADE; IT WAS THEN DISCOVERED THAT THE STENT HAD DISLODGED OUTSIDE OF PATIENT (IN SHEATH) PRIOR TO USE. WHEN INFLATING THE DELIVERY SYSTEM, (PERCEIVED AS DEPLOYMENT ATTEMPT), A DISSECTION OCCURRED. A 3.5X30MM COBRA STENT WAS THEN DEPLOYED OVER THE LESION AND TO TREAT THE DISSECTION SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND THE PATIENT DISCHARGED ON (B)(6)2020.

  Patient problems: Intimal Dissection

  MAUDE report 10002061 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 71-YEAR-OLD MALE WITH MEDICAL HISTORY CORONARY ARTERY DISEASE WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION (PCI) IN 2008, PRIOR CORONARY ARTERY BYPASS GRAFT (CABG) IN 2018, AORTIC STENOSIS WITH PORCINE AORTIC VALVE REPLACEMENT (B)(6) 2018), ATRIAL FIBRILLATION, DIABETES MELLITUS TYPE II, HYPERTENSION, DYSLIPIDEMIA, AND SKIN CANCER. PRESENTED WITH STABLE ANGINA ON (B)(6) 2019. THE PATIENT ENROLLED IN COBRA TRIAL. ANGIOGRAPHY ON (B)(6) 2019 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 ON (B)(6) 2019, PATIENT WAS FEELING INTERMITTENT CHEST PAIN AT REST FOR A WEEK, RADIATING TO LEFT ARM. THE PATIENT HAD EKG CHANGES: ST DEPRESSIONS V2-V4 AND ELEVATED CARDIAC ENZYMES; NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI) WAS DIAGNOSED. ELIQUIS WAS HELD FOR AN ANGIOGRAM WHICH RESULTED IN 80% STENOSIS IN THE LEFT MAIN AND 90% RESTENOSIS IN PROXIMAL LCX (TYPE C LESION). DRUG ELUTING STENTS

  Patient problems: Stenosis

  MAUDE report 9764857 ↗
• MalfunctionAug 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2019, WHEN UNPACKAGING A 3.5X15MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM, THE STENT SHEATH AND STYLET WAS REMOVED WITH VERY LITTLE RESISTANCE WHEN THE STENT CAME OFF WITH THE SHEATH (THE STENT WAS REPORTEDLY STUCK TO ITS PROTECTIVE COVER). THE DEVICE WAS NOT FLUSHED OR PREPPED PRIOR TO SHEATH REMOVAL. THE DEVICE WAS NOT USED IN THE PATIENT. A 3.5MM (LENGTH UNKNOWN) 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 8890084 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A (B)(6)-YEAR-OLD MALE PATIENT WITH A HISTORY OF MULTIVESSEL CORONARY ARTERY DISEASE, PRIOR CORONARY ARTERY BYPASS SURGERY (CABG) IN THE 1990'S, AND PRIOR PERCUTANEOUS CORONARY INTERVENTIONS (PCI) IN SEVERAL VESSELS (2008, 2009, AND 2011), EXTENSIVE PERIPHERAL VASCULAR DISEASE WITH STENTS IN BOTH ILIOFEMORAL SYSTEMS BILATERALLY, PRESENTED WITH PULMONARY LACERATION, MASSIVE HEMOPTYSIS, AND A NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI). PLAVIX WAS STOPPED DUE TO INCREASED RISK OF BLEEDING. ECHOCARDIOGRAM PERFORMED AT ADMISSION SHOWED LEFT VENTRICLE EJECTION FRACTION (LVEF) AT 45-50%. CORONARY ANGIOGRAPHY SHOWED A TOTALLY OCCLUDED RIGHT CORONARY ARTERY (RCA) AND RCA GRAFT WITH FAINT COLLATERALS; SIGNIFICANT OBSTRUCTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) THAT HAD BEEN PREVIOUSLY TREATED WITH DRUG-ELUTING STENTS IN 2011 (WHICH ARE WIDELY PATENT); A CODOMINANT LEFT CIRCUMFLEX (LCX) IN THE ARTERIOVENOUS (AV) GROOVE WITH 80-90% STENOSIS AND NARROWING THROUGHOUT THE ENTIRE LCX TO THE DISTAL TAKEOFF (SEVERE DISEASE PROGRESSION COMPARED TO 2011 ANGIOGRAMS). A VEIN GRAFT TO THE LCX, WHICH WAS A SEQUENTIAL X3 DISTAL ANASTOMOSES REMAINED OPEN IN 2011 AND THE LEFT I

  Patient problems: Thrombosis

  MAUDE report 7788991 ↗