EluNIR Ridaforolimus Eluting Coronary Stent System LUN350R28USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107013796), received between Dec 6, 2018 and Feb 21, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryFeb 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE INITIAL CASE REPORT WAS RECEIVED FROM THE DISTRIBUTER ON JAN. 30TH, 2019. IT STATED: "THE PATIENT HAD AN EXISTING STENT IN THE RCA. THERE WAS A HEAVILY CALCIFIED LESION WITHIN THE EXISTING STENT. THE PHYSICIAN PREPARED THE LESION WITH A 2.5 SEMI-COMPLIANT BALLOON. HE THEN TRIED TO ADVANCE THE 3.5 X 28 ELUNIR. THE STENT WOULD NOT CROSS THE DISTAL LESION. HE REMOVED THE STENT, AND NOTICED THE STENT WAS NOT ON THE BALLOON DELIVERY AFTER REMOVAL. THE STENT WAS SHEARED OFF THE DELIVERY SYSTEM AND STAYED WITHIN THE VESSEL. HE THEN ADVANCED A BALLOON OVER THE WIRE AND EXPANDED/DEPLOYED THE ELUNIR INTO THE PROXIMAL RCA. THE PATIENT WAS NOT INJURED." ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTER ON FEB. 5TH, 2019: A CORDIS HOCKEY STICK GUIDE 6FR, BMW WIRE WAS USED. VESSEL / LESION CHARACTERISTICS: THERE WAS A 99% STENOSIS, NOT HEAVILY CALCIFIED- INSTENT STENOSIS. THERE WAS NO FRICTION ENTERING HEMOSTATIC VALVE. THE VESSEL HAD SOME TORTUROUSLY (MODERATE). THE EVENT CAUSED THE PROCEDURAL TIME TO INCREASE. THE PATIENT WAS NOT INJURED. THE CASE WAS FINISHED WITH AN A STENT FROM A DIFFERENT BRAND. THE STENT WAS STORED THE PROPER WAY. THE STENT PACKAGE WAS NOT DAMAGED. PREP WAS NOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357344 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information

  THE FOLLOWING CASE DESCRIPTION AND THE INFORMATION PROVIDED IN THIS MDR PERTAIN TO THE ELUNIR STENT WHICH ORIGINALLY BELONGED TO (B)(4) (CORDIS CASE-(B)(4)) AND WAS CLASSIFIED AS "NON-REPORTABLE". COMPLAINT (B)(4) WAS CANCELLED AS A STAND-ALONE COMPLAINT ON NOVEMBER 27, 2018, AFTER IT WAS DISCOVERED THAT COMPLAINT (B)(4) IS ACTUALLY PART OF THE SAME PROCEDURE OF COMPLAINT (B)(4) (CORDIS CASE-(B)(4)). THE INFORMATION IN THE CANCELLED COMPLAINT (B)(4) WAS MERGED INTO (B)(4), AND IS PRESENTED IN THIS MDR UNDER THE NAME OF (B)(4). AS A NON-REPORTABLE COMPLAINT, THE CANCELLED COMPLAINT (B)(4) BEARS NO "ADVERSE EVENT OR PRODUCT PROBLEM" CLASSIFICATION OF ITS OWN, BUT CARRIES THE CLASSIFICATIONS OF (B)(4), ONLY FOR THE PURPOSE OF WRITING THIS REPORT: "ADVERSE EVENT AND PRODUCT PROBLEM, REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE". THE COMPLAINT ALSO HAS NO "EVENT PROBLEM AND EVALUATION CODES", EXCEPT FOR THE CONCLUSION CODE. NOTE: AN INITIAL MDR HAS ALREADY BEEN SUBMITTED FOR COMPLAINT (B)(4) (MFR REPORT NO. 3003084171-2018-00051) ON NOVEMBER 07, 2018, BEFORE THE MERGE. A FOLLOW-UP MDR FOR (B)(4) IS SUBMITTED CONCURRENTLY WITH THIS REPORT. CASE DESCRIPTION AS RECEIVED FRO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8137763 ↗