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

Model Number	3.0X20
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event was re-evaluated on apr 04 2018 due to additional information received, and was assessed as mdr reportable.Device not returned to manufacturer.(b)(4).
Event or Problem Description
Information received on mar 18, 2018: no cross of an elunir stent; physician chose another stent that crossed successfully; patient treated and released; no patient injury.Device is not available.Information received on mar 27, 2018: the product stored 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 device from the sterile packaging; the product had not been re-sterilized; the product prepared according to the ifu (instructions for use); there were no anomalies noted during or after the device was prepped; the target lesion was the circumflex; the lesion was severely calcified; there were severely tortuosity and moderately angulation.There were adequate continuous flush maintained through all devices; the device removed intact (in one piece) from the patient; vessel was ballooned and stent was attempted to be delivered.The physician attempted multiple times to deliver the stent in the severely calcified artery.Stent was removed and vessel dilated again.At this time the physician noticed the stent had flared out on the delivery catheter and decided to attempt with a fresh elunir.New stent delivered without a problem.Information received on apr 02, 2018: the distal ends of the stent had been flared, uplifted, pulled away from the balloon catheter.After repeated attempts it was no longer uniformly crimped to the balloon catheter.

• 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: 7471381
• Report Number: 3003084171-2018-00010
• Device Sequence Number: 19230596
• Product Code: NIQ
• UDI-Device Identifier: 07290107013734
• UDI-Public: 07290107013734
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 03/18/2018

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: 10/31/2019
• Device Model Number: 3.0X20
• Device Catalogue Number: LUN300R20US
• Device Lot Number: LNRUS00040
• 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: 04/04/2018
• Initial Report FDA Received Date: 04/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1