EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R17USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107013543), received between May 31, 2018 and Jul 4, 2019 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 4, 2019Crack; Failure to Advance; Crack; Failure to Advance

  INITIAL REPORT FROM THE DISTRIBUTER RECEIVED ON (B)(6) 2019 STATED: "BROKEN SHAFT, CALCIFIED, CIRCUMFLEX " AND NOTED THAT THE DEVICE PROBLEM OCCURRED DURING USE. FURTHER INFORMATION WAS RECEIVED ON JUNE 10, 2019 FROM THE DISTRIBUTOR: THE PATIENT WAS (B)(6) YEARS OLD, MALE. THE DAMAGE NOTED WHILE TRYING TO GET ACROSS A SEVERE STENOSIS. THE DEVICE USED IN THE PATIENT. THE SHAFT HAD BENT DURING THE PROCEDURE AND CRACKED OUTSIDE THE PATIENT BODY THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WASN'T ANY DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE PACKAGE. THERE WASN'T ANY DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE DEVICE WAS NOT DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THERE WASN'T ANY DIFFICULTY INSERTING THE DEVICE INTO THE PATIENT. THERE WAS DIFFICULTY CROSSING THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BRAND. THERE WASN'T ANY PATIENT INJURY. THE PRODUCT WAS REMOVED IN ONE PIECE FROM THE PATIENT EXCEPT FOR THE MID SHAFT THAT WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8762249 ↗
• DeathMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL INFORMATION RECEIVED ((B)(6) 2018): A (B)(6) FEMALE CAME INTO THE ER NONRESPONSIVE, DNR. PATIENT WAS THEN SENT, INTUBATED, TO THE CATH LAB FOR EMERGENT CATHETERIZATION. INITIAL ANGIO REVEALED TOTALLY OCCLUDED LAD. PHYSICIAN PERFORMED MULTIPLE INFLATION ANGIOPLASTY WITH APEX 2.0X12 BALLOON OVER A BMW WIRE. PHYSICIAN THEN DEPLOYED THE 3.0X12 AND THE 2.5X17 ELUNIR, PROXIMAL TO DISTAL, OVERLAPPED, AND PERFORMED FOLLOW UP ANGIOGRAPHY. PHYSICIAN REMOVED HIS GUIDEWIRE, PERFORMED ANOTHER ANGIO AND THEN DETERMINED THE ARTERY NEEDED A THIRD ELUNIR DISTAL TO THE TWO THAT HAD BEEN DEPLOYED. AT THAT TIME, THROMBUS WAS NOTED IN THE MIDSECTION OF THE STENTED SEGMENT, THE PHYSICIAN WAS UNABLE TO REWIRE THE LAD AND THE PATIENT SUCCUMBED WHILE ON THE CATH LAB TABLE ADDITIONAL INFORMATION RECEIVED ((B)(6) 2018): DNR= DO NOT RESUSCITATE / REVIVE THE PRODUCTS WERE STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCTS WERE PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE PATIENT CAME TO CATH LAB ON HEPARIN IV 100 UNITS / HOUR. AND ADDITIONAL 2000 UNITS OF HEPARIN WERE ADMINISTERED DURING THE PROCEDURE. TWO ACTS WERE PERFORMED: 240 AND 300 THE PATIENT PREDIAGNOSIS WAS HYPE

  Patient problems: Sudden Cardiac Death

  MAUDE report 7555848 ↗