EluNIR idaforolimus Eluting Coronary Stent System LUN350R12USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290107013895), received between Dec 22, 2019 and Dec 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2019Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  ACCORDING TO INITIAL REPORT RECEIVED ON AUG 25, 2019: ON (B)(6) 2019, THE PHYSICIAN PERFORMED A CORONARY INTERVENTION ON A (B)(6) FEMALE PATIENT. A 3.5 X 12 ELUNIR WAS SELECTED TO TREAT A CORONARY LESION. IT WAS EXPLAINED TO THE REPORTER THAT THE STENT WAS PREPPED IN USUAL FASHION IN ACCORDANCE WITH THE ELUNIR IFU, UPON PLACING THE STENT ONTO THE .014 INTERVENTIONAL CORONARY WIRE AND INSERTION INTO THE GUIDE CATHETER, THE 3.5 X 12 ELUNIR BECAME STUCK ON THE WIRE INSIDE OF THE GUIDE CATHETER. THE SCRUB TECH AND THE PHYSICIAN WERE UNABLE TO ADVANCE THE STENT ON THE WIRE NOR REMOVE THE STENT FROM THE WIRE. THEREFORE, THE .014 INTERVENTIONAL CORONARY WIRE ALONG WITH THE 3.5 X 12 ELUNIR WERE REMOVED AS A UNIT. THE VESSEL WAS RE-WIRED WITH A NEW .014 INTERVENTIONAL CORONARY WIRE AND TREATED WITH ANOTHER STENT. THERE WAS NO PATIENT INJURY. ADDITIONAL DATE RECEIVED ON SEP. 25, 2019 FROM CORDIS - CARDINAL HEALTH CO.: THE DEVICE WAS STORED IN THE LAB, IN ACCORDANCE WITH THE IFU. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WASN'T ANY REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WASN'T ANY DAMAGE NOTED TO THE PRODUCT UPON INSPECTI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508604 ↗