EluNIR Ridaforolimus Eluting Coronary Stent System LUN350R24USRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290107013819), received between Jul 25, 2018 and Jun 6, 2019 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2019Device Damaged by Another Device; Device Damaged by Another Device

  ACCORDING TO INITIAL REPORT RECEIVED ON MAY 12, 2019: "RUNTHROUGH WIRE WENT DOWN THE ARTERY. STENT WENT OVER THE WIRE TO THE AFFECTED AREA. STENT WAS DIFFICULT TO PASS THE LESION. STENT HAS A SPRING COIL AT THE TIP OF THE STENT AND WITH THE DIFFICULT LESION, THE COIL GOT WRAPPED AROUND THE WIRE AND DUE TO THIS, THE WIRE AND STENT HAD TO BE REMOVED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8674039 ↗
• InjuryNov 7, 2018Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated

  INITIAL CASE DESCRIPTION (RECEIVED FROM CORDIS ON OCT. 11, 2018): 3.5 X 24 ELUNIR SHEARED OFF OF THE BALLOON ATTACHED TO THE DELIVERY SYSTEM FLOATING INSIDE OF AN EXTENSION CATHETER. THE TYPE OF EXTENSION CATHETER USED WAS A GUIDEZILLA MADE BY BOSTON SCIENTIFIC. EXPLANATION OF CASE:THE PHYSICIAN AT (B)(6) HOSPITAL LOCATED IN (B)(6) WAS PERFORMING PCI ON A (B)(6) MALE. ACCESS WAS 6F IN THE RIGHT FEMORAL ARTERY. THE TARGET LESION SITE WAS IN A MID TO DISTAL RPDA SAPHENOUS VEIN GRAFT. THE SVG WAS PREVIOUSLY STENTED AND WAS TOTALLY OCCLUDED. A 6F SYSTEM WAS UTILIZED TO PERFORM THE PROCEDURE. THE GUIDEZILLA WAS RESIDING IN THE STRAIGHT PROXIMAL TO MID SEGMENT OF THE SVG. UPON ADVANCING THE 3.5 X 24 ELUNIR TO THE TARGET LESION SITE IN THE SVG, THE STENT SHEARED OFF OF THE BALLOON INSIDE OF THE GUIDEZILLA EXTENSION CATHETER. NO NEGATIVE PREP WAS PERFORMED PRIOR TO OR DURING ADVANCEMENT OF THE STENT SYSTEM. THE ENTIRE STENT WAS RESIDING INSIDE OF THE EXTENSION CATHETER. THE PHYSICIAN THEN ADVANCED A 2.0MM BALLOON THROUGH THE STENT JUST PAST THE DISTAL TIP OF THE EXTENSION CATHETER AND INFLATED IT. WHILE REMOVING EVERYTHING AS A UNIT DOWN TO THE SHEATH IN THE RFA, THE STENT EMBOLIZED OUTSID

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8045248 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL COMPLAINT, RECEIVED ON JUNE 28, 2018: THE PATIENT RECEIVED AN ELUNIR STENT. FIVE (5) DAYS LATER, HE RETURNED WITH SUB-ACUTE THROMBOSIS. HE WAS TREATED AND RELEASED. ADDITIONAL INFORMATION, RECEIVED ON JULY 01, 2018: INDEX PROCEDURE ((B)(6) 2018): THE PATIENT WAS ADMITTED WITHOUT ACUTE MI. DEPLOYMENT WAS DONE USING 10 ATMOSPHERES FOR 10 SECONDS. THE STENT WAS REPORTED TO BE FULLY APPOSED. NO IVUS WAS CARRIED OUT AFTER STENT DEPLOYMENT. FFR WAS POSITIVE PRIOR TO THE INTERVENTION. THE TARGET LESION WAS DE NOVO LAD/DIAG BIFURCATION WITH 80% STENOSIS, FOR BOTH VESSELS. THE PRODUCT WAS STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION, PRIOR TO USE. THERE NO DIFFICULTY REPORTED WHEN REMOVING THE PRODUCT FROM ITS PACKAGING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY WITHOUT NOTED PROBLEMS, PER THE IFU. THERE WERE NO REPORTED PRODUCT ISSUES OR ADVERSE EVENTS DURING THE PATIENT'S INDEX PROCEDURE. THE PATIENT WAS FULLY ANTICOAGULATED DURING THE INDEX PROCEDURE: SHE RECEIVED 4000 UNITS OF HEPARIN DURING THE PROCEDURE (81 MG ASA PRE/75 PLAVIX PRE). THE PATIENT ST

  Patient problems: Chest Pain; Myocardial Infarction; Thrombosis

  MAUDE report 7721997 ↗
• MalfunctionJul 25, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INITIAL REPORT OF THE COMPLAINT (JULY 01, 2018): AS REPORTED, WHEN THE ELUNIR STENT WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE STENT HAD BEEN PULLED OFF OF THE BALLOON. THE CASE WAS AN INTERVENTIONAL RCA. INITIALLY, THE ELUNIR STENT WAS USED TO GET EXTRA SUPPORT IN THE MID RCA. THE LESION WAS DESCRIBED AS CALCIFIED AND TORTUOUS. A NON-CORDIS GUIDE CATHETER EXTENSION WAS INSERTED. THE ELUNIR STENT WAS RE-INSERTED BUT COULD NOT CROSS THE LESION. ADDITIONAL INFORMATION RECEIVED (JULY 02, 2018): - DURING THE CASE AND AFTER THE CASE ONCE THE STAFF REALIZED THERE WAS A PIECE OF THE STENT DISLODGED FROM THE DELIVERY SYSTEM, THEY IMMEDIATELY DOCUMENTED THE SITUATION AND FOLLOWED THE APPROPRIATE PROTOCOL. - THE WHOLE STENT DID NOT BECOME DISLODGED FROM THE BALLOON AND DELIVERY SYSTEM. IT WAS A VERY TORTUOUS RCA, AND THERE HAD ALREADY BEEN A STENT PLACED IN THE PROXIMAL RCA RIGHT AFTER THE OSTIUM. IT IS THOUGHT THAT TRYING TO PASS THROUGH THE DISTAL END OF THAT STENT OR PASSING NUMEROUS OTHER TURNS IN THE RCA THAT IS WHAT CAUSED THE PIECE TO GET PULLED OFF ( POSSIBLY SOME OF THE HARD CALCIUM). THE PHYSICIAN THEN GOT A GUIDEZILLA CATHETER TO HELP WITH SUPPORT. WHEN REINTRODUCING THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7717808 ↗