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); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
The stent was used in a calcified artery.The physician could not deliver the stent so she pulled back into the guide and the stent was dislodged.The physician had to fish it out with a balloon.There was no patient injury.
Additional Manufacturer Narrative
Ifu review (july 10, 2018) - no information was received, therefore it's unknown if there was any violation of the ifu.Final report (july 12, 2018) - overall conclusions: 1.The review of the dhr (device history record) indicates that the product was supplied meeting specifications.2.'failure to cross' is a known procedural occurrence that is commonly related to patient anatomy, lesion disposition/composition, operator technique, ancillary equipment and appropriate device selection.3.There is no evidence to suggest that there were any manufacturing issues that contributed to the reported events.4.The investigation was limited as we did not receive the used product.It is not possible to reach a definite conclusion as to how and why these events happened with the limited information that we received.5.There was no injury to patient.

• 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: 7608484
• Report Number: 3003084171-2018-00026
• Device Sequence Number: 13859064
• 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,Followup
• Report Date (Section B): 05/24/2018

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: 12/31/2019
• Device Model Number: 3.0X20
• Device Catalogue Number: LUN300R20US
• Device Lot Number: LNRUS00091
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 06/17/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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