EluNIR Ridaforolimus Eluting Coronary Stent System LUN350R33USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07290107013765), received between Apr 3, 2018 and Mar 22, 2020 — classified as 1 death, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CASE DESCRIPTION RECEIVED FORM THE DISTRIBUTOR ON FEB 27, 2020: AS REPORTED, THE DR JUST USED AN ELUNIR LUN350R33US LOT #LNRUS00307. WHEN THE DR GOT THE ELUNIR TO HIS DESIRED DESTINATION THE STENT CAME OFF THE BALLOON. OCCURED INSIDE PATIENT. THE DEVICE WAS NOT IMPLANTED NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON MAR 15, 2020: THE INTENDED PROCEDURE WAS SFA/ TIBIAL'S THE BALLOON USED WAS A 0.18 SABER USED FOR SFA. SNARING OUT WAS THE INTERVENTION DONE BECAUSE OF THE STENT DISLODGEMENT. NO PATIENT INFORMATION AVAILABLE, SUCH AS AGE, DATE OF BIRTH, WEIGHT, HEIGHT, GENDER, MEDICAL HISTORY. THE TARGET LESION WAS ANTERIOR TIBIAL. NO VESSEL TORTUOSITY. THE LESION WAS CALCIFIED MODERATELY. UNKNOWN PERCENTAGE OF STENOSIS. THE DEVICE WAN NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). UNKNOWN VESSEL ANGULATION. THE DEVICE WAS STORED, PREPPED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE NOTED TO THE PACKAGE. NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE DEVICE PREPPED NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). UNKNOWN IF THERE WERE ANY ANOMA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863675 ↗
• InjuryFeb 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE INITIAL REPORT WAS RECEIVED FROM THE DISTRIBUTER ON FEB. 6TH, 2019: "FROM WHAT I UNDERSTAND THE DOCTOR WAS INTENDING THE STENT TO BE DEPLOYED IN A DISTAL LESION AND INSTEAD THE STENT STRIPPED OFF FROM THE BALLOON CATHETER IN THE PROXIMAL PART OF THE VESSEL AT WHICH POINT HAD TO BE DEPLOYED IN THAT LOCATION THE DEVICE WAS PREPPED ACCORDING TO IFU. THERE WAS NO PATIENT INJURY" THE TOTAL IMPLANTED QUANTITY IS 1. ADDITIONAL INFORMATION WAS RECEIVED ON FEB. 13TH, 2019: THE TARGET LESION WAS DISTAL CIRC. THE LESION WASN'T CALCIFIED. THERE WAS LITTLE VESSEL TORTUOSITY. THERE WASN'T ANY VESSEL ANGULATION. THE PRODUCT WAS STORED, HANDLED AND PREPARED ACCORDING TO THE IFU. THERE WASN'T ANY EXCESSIVE FORCE APPLIED ON THE STENT DELIVERY SYSTEM WHILE INSERTING IT OVER THE GUIDE WIRE. THE STENT DIDN'T KINK WHILE BEING USED. THERE WASN'T ANY DIFFICULTY CROSSING THE LESION. THE STENT WASN'T EVER IN AN ACUTE BEND. THERE WASN'T ANY DAMAGE NOTED TO THE PACKAGING OF THE DEVICE, NOR KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE PATIENT WENT HOME THAT SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED ON FEB. 17TH, 2019: THE PROCEDURE WAS SUCCESSFUL. THE WIRE BRAND IS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377031 ↗
• DeathAug 30, 2018Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  INITIAL DESCRIPTION OF THE EVENT: STENT STRIPPED OFF DELIVERY SYSTEM. IT WAS INTENDED FOR THE LAD AND STRIPPED OFF PROXIMAL LAD AND BROUGHT BACK THROUGH THE GUIDE RADIAL. IT WOULD (NOT) COME OUT OF THE RADIAL ARTERY AND THEREFORE HE ACCESSED FEMORAL AND SNARE THE STENT INTO THE FEMORAL. PATIENT PASSED AFTER THE PROCEDURE ON THE FLOOR. ADDITIONAL INFORMATION RECEIVED: FROM (B)(6), AUGUST 06, 2018: THE STENT DELIVERY SYSTEM IS AVAILABLE FOR RETURN. THE STENT WAS NOT KEPT ONCE IT WAS TAKEN OUT OF THE PATIENT. IT WAS TOLD THAT THE STENT HAD NOTHING TO DO WITH THE DEATH LATER ON. FROM (B)(6), AUGUST 13, 2018: THE DEVICE WAS NOT USED IN AN ACUTE MI SETTING. THE LESION WAS NOT IN STENT RE-STENOSIS. THERE WERE MORE THAN TWO (2) STENTS DEPLOYED. A GUIDELINER WAS USED AS THE GUIDE EXTENSION SYSTEM. THE PHYSICIAN HAD DIFFICULTY CROSSING THE LESION WITH THE DEVICE THE PHYSICIAN ATTEMPTED TO RETRACT THE SYSTEM WITH THE GUIDE CATHETER, WHICH PULLED BACK INTO THE GUIDE LINER AND THEN THE WHOLE SYSTEM WAS REMOVED RADIALLY BUT THE STENT STAYED AND WAS IN THE RADIAL ARTERY. IT IS NOT SURE WHETHER AN AUTOPSY WAS PERFORMED. FROM (B)(6), AUGUST 21, 2018: IT IS UNKNOWN WHAT THE REASON WAS FOR THE PATIEN

  Patient problems: Death

  MAUDE report 7832067 ↗
• MalfunctionMay 3, 2018Difficult to Remove; Difficult to Remove

  THE PHYSICIAN DEPLOYED 3 ELUNIR STENTS IN THE PATIENT'S LAD. EACH STENT DELIVERED WITH NO PROBLEM TO THE INTENDED LOCATION. PROX,MID, AND DISTAL LAD. WHEN THE PHYSICIAN TRIED TO WITHDRAW THE BALLOONS AFTER DEPLOYMENT OF THE STENTS, EACH ONE WAS STICKING TO THE STENT AND WAS DIFFICULT TO WITHDRAW. THE PHYSICIAN COMMENTED THAT OUR BALLOONS ARE "STICKY" AND DON'T SEPARATE EASILY FROM THE STENTS ONCE DEPLOYED. IT WAS A PROBLEM. HE HAD TO WIGGLE THEM FOR ABOUT 3 SECONDS EACH AND PULL BACK MORE THAN NORMAL CAUSING THE GUIDE TO ADVANCE. THERE WAS NO PATIENT ISSUES AFTERWARDS. ALL 3 BALLOONS WERE DISCARDED IMMEDIATELY AFTER THE PROCEDURE AND ARE NOT AVAILABLE TO SEND IN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7482211 ↗
• MalfunctionApr 4, 2018Difficult to Remove; Difficult to Remove

  THE OBTUSE MARGINAL CONTAINED SOME MILD TO MODERATE TORTUOSITY (PROXIMAL TO THE LESION SITE) AND A MODERATE TO SEVERE CALCIFIED STENOTIC LESION. INTERVENTION ENSUED AND THE LESION SITE WAS PRE-DILATED WITH A 3.0 TREK SEMI-COMPLIANT BALLOON PRIOR TO PLACEMENT OF A 3.5 X 33 ELUNIR STENT. THE STENT DELIVERED WITHOUT DIFFICULTY THROUGH A 6F EBU GUIDING CATHETER (ENGAGED COAXIALLY TO THE LEFT MAIN) TO THE SITE OF THE STENOTIC LESION AND WAS DEPLOYED AT NOMINAL PRESSURE (10 ATM). POST-DEPLOYMENT OF THE ELUNIR, AFTER DEFLATION OF THE BALLOON, THE PHYSICIAN EXPERIENCED MILD TO MODERATE DIFFICULTY REMOVING THE BALLOON. TO ASSIST WITH REMOVAL OF THE BALLOON, IT WAS SUGGESTED PULLING NEGATIVE TWICE TO RETURN THE BALLOON TO ITS SMALLEST POST-DEPLOYMENT PROFILE. AFTER SUCCESSFUL REMOVAL OF THE BALLOON, THE PHYSICIAN VERBALIZED THE MILD TO MODERATE DIFFICULTY HE EXPERIENCED WHILE REMOVING THE BALLOON POST DEPLOYMENT OF THE ELUNIR. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED IN MARCH 19, 2018: THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU); NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE; NO DIFFICULTY WAS NOTED DURING REMOVAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7395311 ↗
• InjuryApr 3, 2018Difficult to Remove; Difficult to Remove

  THE PHYSICIAN IMPLANTED TWO ELUNIR, UPON THE DEPLOYMENT OF THE SECOND STENT, HE ENCOUNTERED SIGNIFICANT RESISTANCE IN REMOVING THE BALLOON. HIS TAKE WAS THE BALLOON WAS STUCK ON THE WIRE. EVENTUALLY, THE CLINICIAN REMOVED THE WIRE AND BALLOON AND UNFORTUNATELY UPON DOING FIRST THIS, LOST FLOW IN THE LAD. THE PATIENT ENDED UP GOING TO SURGERY AND IS NOW STABLE. ADDITIONAL INFORMATION RECEIVED ON MAR 20, 2018, FROM THE OPERATOR: THE LESION WAS A PROXIMAL / MID LAD LESION; THE FIRST ELUNIR WAS PLACED DISTALLY (MID LAD) WITH NO DIFFICULTY; THE MORE PROXIMAL LESION WAS A SIMPLE TYPE A LESION. IT WAS EASY TO CROSS AND EASY TO PRE-DILATE; THE WIRE USED WAS A BMW UNIVERSAL; A GUIDELINER WAS ALSO USED. A 3.5X17 MM ELUNIR STENT WAS INSERTED WITHOUT DIFFICULTY; PRESSURE WAS NEUTRAL DURING INSERTION; STENT WAS DEPLOYED AT NOMINAL PRESSURE (10 ATM). SDS DEFLATION WAS NORMAL AND THE OPERATOR WAS SURE THAT THE BALLOON DEFLATED FULLY; UPON ATTEMPTING TO REMOVE THE SDS, IT WOULD NOT MOVE WITHOUT THE GUIDEWIRE; ULTIMATELY, THE SDS WAS REMOVED TOGETHER WITH THE STENT. IMMEDIATELY AFTERWARDS, THE LAD BECAME OCCLUDED; OPERATOR DOES NOT KNOW WHETHER THIS WAS DUE TO A DISSECTION OR TO THROMBUS, BUT BELIE

  Patient problems: Stenosis

  MAUDE report 7391369 ↗