MAUDE Adverse Event Report: MEDINOL LTD ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT,

Model Number	4X15
Medical Device Problem Codes	Off-Label Use (1494); Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Several unsuccessful attempts were made to receive additional information from the distributor since the complaint opening date.Investigation findings have classified his case as off label use.
Event or Problem Description
Initial case detail report received form cordis on nov 24, 2019 have stated the following: as reported, the dr was pushing the stent in the left pt artery and the elunir stent got caught on a smart stent strut and came off the balloon.The dr was able to smash the elunir stent within the other stent and there was no issue or injury for the patient.No patient injury.
Additional Manufacturer Narrative
Device history record (dhr) review (dated dec 23 , 2019) have indicated the product was supplied meeting specifications.Ifu review (dated jan.08, 2020) was conducted and indicated that the elunir stent was used in proximal tibial artery (leg).The use of elunir stent in the leg is not indicated for use in the ifu and is a violation of section 2 of ifu.Device analysis (dated dec.23, 2019) concluded that little detail has been provided as to the circumstances and/or chain of events that brought about the reported tracking difficulty through another stent and stent dislodgement, and no definite conclusion can be made from the device analysis as to the circumstances which brought about the reported complaint.Based on this investigation it may be surmised that the product was supplied meeting specifications.Results of this investigation did not reveal any indication that the customer reported failure is related to medinol manufacturing processes.Overall final report conclusions (dated jan.15, 2020): 1.The review of the dhr (device history record) and the returned product analysis indicate that the product was supplied meeting specifications.2.While no definite conclusion can be made as to the circumstance of the tracking difficulty through another stent and stent dislodgement, there are no indications that they are related to medinol's manufacturing processes.3.The elunir stent is not indicated for use in the pt artery (leg) and is a violation of section 2 of the ifu.4.There was no patient injury.(b)(4).

• Brand Name: ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: CORONARY DRUG-ELUTING STENT,
• Manufacturer (Section D): MEDINOL LTD; beck-tech bldg.; har hotzvim b, 8 hartom st.,; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 9488738
• Report Number: 3003084171-2019-00020
• Device Sequence Number: 11115250
• Product Code: NIQ
• UDI-Device Identifier: 07290107013864
• UDI-Public: 07290107013864
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: P170008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 4X15
• Device Catalogue Number: LUN400R15US
• Device Lot Number: LNRUS00125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/24/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR