EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R12USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290107013703), received between May 31, 2018 and Dec 12, 2019 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL CASE REPORT WAS OBTAINED ON NOV. 17, 2019 AND INCLUDED THE FOLLOWING "DESCRIPTION AS REPORTED": "AS REPORTED BY THE SALES REP, PATIENT CAME IN WITH A STEMI ON (B)(6) DUE TO IN STENT THROMBOSIS. PATIENT WAS ON BRILINTA AND WENT OFF DUE TO FINANCIAL REASONS. AFTER PROCEDURE THE PATIENT WAS PUT ON PLAVIX. IT IS UNKNOWN IF THE PATIENT'S DOSAGE WAS CORRECT FOR PLAVIX OR IF THE PATIENTS BODY DIDN'T RESPOND TO THE MEDICATION AS WELL AS IT WASN'T IN THE PATIENTS SYSTEM LONG ENOUGH AFTER THE PROCEDURE WHICH COULD HAVE CAUSED THE ELUNIR STENTS TO SHUT DOWN. BOSTON SCI SYNERGY STENTS WERE PLACED IN THE MID CIRC AND MID LAD" IN ADDITION, THE INFORMATION DETAILED IN 'PRODUCT INFORMATION' IN THE SAME REPORT INCLUDED FOUR (4) PRODUCTS. THERE HAVE BEEN SEVERAL ATTEMPTS TO GET INFORMATION ABOUT WHICH PRODUCT WITHIN THE REPORTED FOUR (4) WAS INVOLVED, BUT NO ANSWER HAS BEEN RECEIVED ON THIS MATTER. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON DEC 3, 2019 STATED AS FOLLOWS: THE DEVICE STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE DEVICE PREP AS PER THE IFU 1 STENT IN MID CIRC AND 1 STENT IN MID LAD NONE WERE OVERLAP

  Patient problems: Thrombosis

  MAUDE report 9458205 ↗
• InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL CASE REPORT WAS OBTAINED ON NOV. 17, 2019 AND INCLUDED THE FOLLOWING "DESCRIPTION AS REPORTED": "AS REPORTED BY THE SALES REP, PATIENT CAME IN WITH A STEMI ON (B)(6) DUE TO IN STENT THROMBOSIS. PATIENT WAS ON BRILINTA AND WENT OFF DUE TO FINANCIAL REASONS. AFTER PROCEDURE THE PATIENT WAS PUT ON PLAVIX. IT IS UNKNOWN IF THE PATIENT'S DOSAGE WAS CORRECT FOR PLAVIX OR IF THE PATIENTS BODY DIDN'T RESPOND TO THE MEDICATION AS WELL AS IT WASN'T IN THE PATIENTS SYSTEM LONG ENOUGH AFTER THE PROCEDURE WHICH COULD HAVE CAUSED THE ELUNIR STENTS TO SHUT DOWN. BOSTON SCI SYNERGY STENTS WERE PLACED IN THE MID CIRC AND MID LAD." IN ADDITION, THE INFORMATION DETAILED IN 'PRODUCT INFORMATION' IN THE SAME REPORT INCLUDED FOUR (4) PRODUCTS. THERE HAVE BEEN SEVERAL ATTEMPTS TO GET INFORMATION ABOUT WHICH PRODUCT WITHIN THE REPORTED FOUR (4) WAS INVOLVED, BUT NO ANSWER HAS BEEN RECEIVED ON THIS MATTER. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON DEC 3, 2019 STATED AS FOLLOWS: THE DEVICE STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE DEVICE PREP AS PER THE IFU 1 STENT IN MID CIRC AND 1 STENT IN MID LAD NONE WERE OVERLA

  Patient problems: Thrombosis

  MAUDE report 9458194 ↗
• DeathMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL INFORMATION RECEIVED (MAY 04, 2018): A (B)(6) YO 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 (MAY 27, 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

  Patient problems: Sudden Cardiac Death

  MAUDE report 7555851 ↗