Cobra PzF 170-03-30030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00879397000821), received between Aug 16, 2018 and Feb 21, 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 16, 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 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR TREATMENT OF A LESION IN A NATIVE (UNSPECIFIED) CORONARY VESSEL AT AN UNSPECIFIED DATE (ON OR BEFORE (B)(6) 2020), THE LESION WAS PREPPED WITH A CUTTING BALLOON, FOLLOWED BY DEPLOYMENT OF A 3.0X30MM (LOT # 1703074001) COBRA PZF NANOCOATED STENT (AT 18 ATMOSPHERES). AFTER STENT DEPLOYMENT, A PERFORATION WAS OBSERVED AND THE PATIENT BEGAN TO CODE. WHILE PATIENT OUTCOME IS UNKNOWN, TO DATE, THE PATIENT IS NOT DECEASED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 9741639 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A 67-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 INTER

  Patient problems: Thrombosis/Thrombus

  MAUDE report 7789036 ↗