Cobra PzF 170-03-35012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00879397000845), received between Mar 22, 2018 and Dec 17, 2019 — classified as 1 death, 1 injury.

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

• InjuryDec 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 22-NOVEMBER-2019, PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED AS FOLLOWS FOR TREATMENT OF A LESION IN THE MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY: NO PRE-DILATAITON WAS PERFORMED. A 3.5X12MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS UNPACKAGED AND PREPPED PER USUAL PROCEDURE WITHOUT ISSUE; THE TECHNICIAN OBSERVED THE STENT TO REMAIN ON DELIVERY SYSTEM PRIOR TO USE AND HANDED OFF SYSTEM TO PHYSICIAN, WHO BELIEVED STENT WAS ON DEVICE. THE DELIVERY SYSTEM WAS THEN INSERTED INTO GUIDE CATHETER AND ADVANCED TO LESION WITHOUT DIFFICULTY AND WITHOUT RESISTANCE; THE DEVICE WAS INFLATED AT THE LESION. UPON WITHDRAWAL OF THE DELIVERY SYSTEM, THE PHYSICIAN NOTED THAT THE STENT WAS NOT AT THE LESION SITE AND NOT ON THE DELIVERY SYSTEM. STENT WAS UNABLE TO BE LOCATED VIA IMAGING. ALTHOUGH THE STENT WAS UNABLE TO BE FOUND IN ANATOMY ANGIOGRAPHICALLY, OR IN THE CATH LAB, THE PHYSICIAN IS UNABLE TO CONFIRM IF STENT REMAINS IN PATIENT ANATOMY. PLAQUE SHIFT AND DISSECTIONS WERE NOTED ON ANGIOGRAPHY, BUT WERE NOT FLOW-LIMITING. THE TARGET LESION WAS TREATED VIA DEPLOYMENT OF A DRUG-ELUTING STENT. NO ADVERSE EVENTS WERE NOTED DURING OR IMMEDIATELY AFTER

  Patient problems: Foreign Body In Patient

  MAUDE report 9480826 ↗
• DeathMar 22, 2018Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED, RESULTING IN THE FOLLOWING REVISED EVENT DESCRIPTION: A (B)(6) MALE PRESENTED WITH A MEDICAL HISTORY OF ANGINA PECTORIS WITH MULTIVESSEL DISEASE, TYPE 2 DIABETES, PERIPHERAL VASCULAR DISEASE, CHRONIC RENAL DISEASE, OSTEOMYELITIS IN THE FOOT, BENIGN PROSTATIC HYPERPLASIA (BPH) WITH MINIMAL INVASIVE SURGERY PERFORMED (DATE NOT STATED) AND POLYNEUROPATHY. IN (B)(6) 2017, HE WAS RECOMMENDED FOR CORONARY ARTERY BYPASS SURGERY (CABG). IN (B)(6) 2017, THE PATIENT SOUGHT A SECOND OPINION. A REVIEW OF HIS PRIOR ANGIOGRAM SHOWED SIGNIFICANT LESION IN THE OSTIUM OF THE LEFT CIRCUMFLEX (LCX) AND SUBSEQUENTLY, PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS RECOMMENDED AFTER ADDRESSING HIS BPH SURGERY TO MINIMIZE HIS RISK OF BLEEDING. ON (B)(6) 2018, THE PATIENT WAS ADMITTED FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE PATIENT MEDICATIONS ON ADMISSION: ATORVASTATIN, AVODART, ASPIRIN, FLOMAX AND PLAVIX. DISCONTINUED METFORMIN RECENTLY. ON (B)(6) 2018, THE PATIENT UNDERWENT A PTCA VIA RIGHT RADIAL APPROACH. A JACKY CATHETER WAS USED TO PERFORM THE DIAGNOSTIC ANGIOGRAM OF BOTH THE LEFT AND RIGHT CO

  Patient problems: Angina; Bradycardia; Cardiac Arrest; Death; Foreign Body In Patient; Ischemia; Low Blood Pressure/ Hypotension; Myocardial Infarction; Occlusion; Pulmonary Edema; Vasoconstriction; Ventricular Fibrillation; Ventricular Tachycardia

  MAUDE report 7364587 ↗