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

Model Number	2.5X17
Medical Device Problem Codes	Crack (1135); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr review indicates that the product was supplied meeting specifications.Ifu review was preformed and no deviation from the ifu was reported.Conclusions of the final report of the complaint investigation: the review of the dhr (device history records), along with the information from the customer and the device analysis report indicate that the product was supplied meeting specifications.According to the device analysis, it may be assumed that the failure to cross, the broken shaft and the damage observed to the stent and tip evidently are the consequence of one or a combination of the common issues mentioned above and the use of excessive force, and are not related to medinol's manufacturing processes.There were no indications of any product anomalies or manufacturing issues.There was no injury to patient.No corrective action is required for this complaint.
Event or Problem Description
Initial report from the distributer received on (b)(6) 2019 stated: "broken shaft, calcified, circumflex " and noted that the device problem occurred during use.Further information was received on june 10, 2019 from the distributor: the patient was (b)(6) years old, male.The damage noted while trying to get across a severe stenosis.The device used in the patient.The shaft had bent during the procedure and cracked outside the patient body the product was stored and handled according to the instructions for use.There wasn't any damage noted to the packaging of the device.There was no difficulty removing the products from the package.There wasn't any difficulty experienced in prepping the device.The device was not damaged in any way prior to insertion into the patient.There wasn't any difficulty inserting the device into the patient.There was difficulty crossing the lesion.The procedure was completed with a different brand.There wasn't any patient injury.The product was removed in one piece from the patient except for the mid shaft that was broken.

• 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: 8762249
• Report Number: 3003084171-2019-00010
• Device Sequence Number: 11380972
• Product Code: NIQ
• UDI-Device Identifier: 07290107013543
• UDI-Public: 07290107013543
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2019

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: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 2.5X17
• Device Catalogue Number: LUN250R17US
• Device Lot Number: LNRUS00069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR