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

Model Number	2.5X24
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
Physician inserted stent delivery system on wire and could not cross once at the lesion.When the physician attempted to take the stent catheter off the wire, it would not come off so the physician was required to take both the wire and stent off simultaneously.Information received on may.07, 2018: the device problem occurred during the procedure in patient.There was no injury to patient.Additional data received on may 09, 2018: the product was stored and prepped properly according to the instructions for use (ifu).There was no damage to the product packing noticed prior to use.There was no difficulty removing the product from the packaging.There were no anomalies noted during or after the device was prepped.There was adequate continuous flush maintained through all devices.It was verified prior to insertion that the stent was contained within the outer sheath/introducer of the system.The guidewire port was flushed as outlined in the ifu prior to loading on the guidewire.The device was removed intact (in one piece) from the patient.Additional data received on may.10, 2018: the physician used excessive force while trying to cross the lesion.The guide wire was used for a balloon before mounting the elunir system.The guide wire that used was bmw (bare metal wire).The lesion was not calcified but with vessel tortuosity/ angulation.The physician did not do anything further after not being able to deploy elunir.

• Brand Name: ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 7556727
• Report Number: 3003084171-2018-00025
• Device Sequence Number: 1775358
• Product Code: NIQ
• UDI-Device Identifier: 07290107013567
• UDI-Public: 7290107013567
• Combination Product (Y/N): N
• PMA/510(K) Number: P170008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: 2.5X24
• Device Catalogue Number: LUN250R24US
• Device Lot Number: LNRUS00094
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1