Cobra PzF 170-03-35024Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00879397000876), received between Jun 8, 2018 and May 10, 2021 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, A (B)(6)-YEAR-OLD MALE PATIENT WITH SEVERE BRADYCARDIA, HYPERTENSION, HYPERLIPIDEMIA, CHRONIC ATRIAL FIBRILLATION, UNDER CARDIAC ARREST AND RECEIVING CARDIOPULMONARY RESUSCITATION (CPR), PRESENTED TO EMERGENCY DEPARTMENT (ED). AFTER 15 TO 20 MINUTES OF CPR AND 6 SHOCKS, RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED. THE PATIENT WAS STARTED ON PRESSORS AND HEPARIN, GIVEN EXTERNAL PACEMAKER, WAS SEDATED, INTUBATED, AND VENTILATED. DIAGNOSTIC ANGIOGRAPHY SHOWED 90% CALCIFIED LESION IN A POSTEROLATERAL ARTERIAL BRANCH (PLB) AND 80% CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) (DOMINANT). A TEMPORARY INTERNAL PACEMAKER WAS IMPLANTED THEN THE LESIONS WERE PRE-DILATED WITH A 2.5X15MM BALLOON. AS THE PATIENT WAS AT HIGH RISK FOR BLEEDING FOR BEING ON ELIQUIS, ANTICOAGULANT MEDICATION, FOR THE CHRONIC ATRIAL FIBRILLATION, COBRA PZF¿ NANOCOATED STENTS WERE SELECTED FOR TREATMENT OF THE LESIONS. USING A GUIDELINER SUPPORT CATHETER (SIZE UNKNOWN), TWO OVERLAPPING COBRA PZF¿ NANOCOATED CORONARY STENTS (3.5X24MM AND 3.5X15MM) WERE DEPLOYED IN THE DISTAL RCA AND PLB LESIONS AT 10 ATMOSPHERES (ATMS) AND POST-DILATED TO 13 ATMS WITHOUT COMPLICATION, RESULTING I

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 11802376 ↗
• InjuryFeb 19, 2020Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  ON (B)(6) 2020, THE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR TREATMENT OF A HEAVILY CALCIFIED LESION IN THE MODERATELY TORTUOUS MID LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. ACCESS WAS GAINED VIA RIGHT RADIAL ARTERY, THEN PRE-DILATION WAS PERFORMED USING A 2.5X20MM BALLOON. A 3.5X24MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS THEN ADVANCED OVER A RUNTHROUGH GUIDE WIRE; THE COBRA WAS UNABLE TO CROSS DUE TO LESION CALCIFICATION. DURING THE CROSSING ATTEMPT, THE STENT BECAME DAMAGED (DEFORMED) AND DISLODGED IN THE LCX PRIOR TO REACHING TARGET. THE GUIDE WIRE THEN COBRA STENT SYSTEM WERE EACH WITHDRAWN (RESPECTIVELY). ATTEMPTS WERE MADE TO SNARE THE STENT USING SMALL BALLOONS AND A 4MM GOOSENECK SNARE DEVICE, BUT SNARING ATTEMPTS WERE UNSUCCESSFUL. A SMALL BALLOON WAS ADVANCED THROUGH THE STENT THEN SLIGHTLY INFLATED TO PREVENT FURTHER STENT MIGRATION; THE STENT WAS UNABLE TO BE PULLED BACK THROUGH THE INTRODUCER SHEATH, AT THE RADIAL LOCATION, USING THE SMALL BALLOON, THUS, THE PHYSICIAN DECIDED TO DEPLOY THE STENT IN THE RIGHT RADIAL ARTERY WITH PLAN TO REFER PATIENT TO SURGERY AFTER STENTING PROCEDURE. ADDITIONAL PRE-DILATATION THEN WAS PERFORMED IN THE

  Patient problems: Foreign Body In Patient

  MAUDE report 9728366 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) YEARS OLD MALE WITH MEDICAL HISTORY OF CORONARY ARTERY DISEASE, CHRONIC HEART FAILURE WITH EJECTION FRACTION (EF) = 40%, PULMONARY EMBOLISM ON ORAL ANTI-COAGULANT (OAC) THERAPY, HYPERTENSION, DYSLIPIDEMIA. PRESENTED WITH UNSTABLE ANGINA. THE PATIENT ENROLLED IN (B)(6) TRIAL (B)(6) 2019. ANGIOGRAPHY SHOWED SIGNIFICANT TYPE C LESION IN MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). PERCUTANEOUS CORONARY INTERVENTION (PCI) WITHOUT PRE-DILATION, PLACEMENT OF COBRA PZF¿ (3.5X 24) STENT IN MLAD. NO POST DILATION WAS PERFORMED. THE POST-PROCEDURE COURSE WAS UNCOMPLICATED, AND TIMI FLOW 3 NOTED. THE PATIENT PRESENTED ON (B)(6) 2019 WITH CHEST PAIN, EVALUATED TO MYOCARDIAL INFARCTION (MI) DIAGNOSED. THE PATIENT STOPPED HIS NOAC MEDICATION ON HIS OWN ONE MONTH PRIOR TO THE EVENT AND REMAINS ON ASPIRIN ALONE, AS REPORTED BY THE PATIENT. CORONARY ANGIOGRAPHY SHOWED MILD DIFFUSE DISEASE AND IN THE 1ST OBTUSE MARGINAL (OM), 60% STENOSIS IN THE 2ND OM, AND TOTAL OCCLUSION IN THE MLAD. THE MLAD LESION WAS PRE-DILATED AND 3.5X30 DES WAS PLACED WITH GOOD ANGIOGRAPHIC RESULTS. PATIENT WAS RE-ADMITTED ON (B)(6) 2019 WITH POST-MI PERICARDITIS. PATIENT HAD BEEN DISCHARGED ON COCHICINE AND HIGH-DOSE

  Patient problems: Myocardial Infarction; Myocarditis; Occlusion; Thrombosis

  MAUDE report 9513028 ↗
• MalfunctionNov 18, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  A FEMALE PATIENT PRESENTED FOR PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI). ANGIOGRAPHY PERFORMED ON (B)(6) 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 DURING RETRACTION INSIDE OF A 7F GUIDE CATHETER. IN EACH OCCURRENCE, THE STENT AND GUIDE CATHETER WERE RETRIEVED AS SINGLE UNIT WITHOUT INJURY TO PATIENT. A 3.5X16MM DRUG-ELUTING STENT ULTIMATELY CROSSED AND WAS DEPLOYED IN THE RCA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335774 ↗
• MalfunctionNov 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER UNPACKAGING A 3.5X24MM COBRA PZF¿ NANOCOATED STENT SYSTEM WITHOUT ISSUE ON (B)(6) 2019, FOR PLANNED USE IN A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE STENT CAME OFF BALLOON WHEN TECHNICIAN WAS PULLING NEGATIVE PRESSURE DURING PREPARATION WITH CONTRAST. THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT AT ANY TIME. ANOTHER SAME SIZE COBRA DEVICE WAS PREPPED AND DEPLOYED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9273010 ↗
• MalfunctionAug 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2019, WHEN UNPACKAGING A 3.5X24MM 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 3.5X30MM 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 8856288 ↗
• InjuryJun 8, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AFTER PERFORMING ATHERECTOMY AND PRE-DILATATION, A COBRA PZF NANOCOATED STENT (SIZE UNSPECIFIED) WAS DEPLOYED IN THE VERY SHARP, HOOKED-SHAPED OSTIAL TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITHOUT ANY REPORTED ISSUE. A 3.5X24MM COBRA PZF NANOCOATED STENT SYSTEM WAS THEN ADVANCED VIA GROIN ACCESS, TO BE PLACED IN THE SEVERELY CALCIFIED OSTIUM OF THE LAD, OVERLAPPING THE PREVIOUSLY DEPLOYED STENT, BUT THE DEVICE WAS UNABLE TO CROSS THE REMAINING PROXIMAL LESION DUE TO THE SHARP LAD CURVE. DURING WITHDRAWAL, NO RESISTANCE WAS FELT, BUT STENT SLID OFF BALLOON DURING WITHDRAWAL; REPORTEDLY, THE STENT MAY HAVE CAUGHT A PROXIMAL STRUT OF THE PREVIOUSLY IMPLANTED STENT DUE TO THE SHARP LAD BEND. NO GUIDELINER WAS USED. THE DISLODGED STENT WAS SNARED WITHOUT ISSUE. ANOTHER COBRA WAS USED TO SUCCESSFULLY TREAT THE OSTIAL LAD LESION. THERE WERE NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7584667 ↗