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

Model Number	3.5X15
Medical Device Problem Codes	Device Slipped (1584); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available.
Event or Problem Description
The doctor was stenting the right coronary and while placing the stent it came off the balloon.They tried to put another balloon in to pull it back into the guide but they weren't able to do so.They were able to move the stent forward and place it somewhat in the area they wanted.The patient went home ok with the elunir stent.Additional information received on june 13th, 2018: patient is a male, (b)(6) years old.This was the first time the physician had used elunir stent system and the device was prepared according to the ifu.The physician did not experience any difficulty in preparation the device.The target vessel was the right coronary artery (rca), the physician reached the target site accessing the femoral artery, target vessel was not very tortuous and not calcified much.The stent was not manipulated during the preparation and was properly mounted on the system when inspected prior to use.No kinks or other damages noted prior to inserting the product into the patient and there was no resistance/friction while inserting the delivery system through the guide wire.No excessive force was used during the procedure.Prior to sds insert, the balloon was not inflated nor partially inflated.Negative pressure had been applied prior to use.The inflation device was in the neutral position when the system was being advanced/withdrawn.The physician did not inflate the balloon of the delivery system before stent dislodgment when he reached the target site.The stent dislodged before inflation of balloon, while passing through an old stent.The procedure completed with the same dislodged stent.No cd/angiogram of the procedure is available for review.No patient injury, patient was sent home next day.
Additional Manufacturer Narrative
Correction of information provided on the first mdr (july 01, 2018): section b1 - both "malfunction" and "adverse event" should have been checked (mistakenly, only malfunction was previously checked).In this report both were checked.Section b2 - outcomes attributed to adverse event - "other serious" should not have been checked, since there were no other events except for the moving the stent forward."required intervention to prevent permanent impairment" was previously checked and is correct.Section h1 - type of reportable event - was previously checked as "malfunction", corrected to "serious injury" ifu review (july 15, 2015) - no deviation of ifu was reported.Final report (july 15, 2018) - overall conclusions: 1.The review of the dhr (device history record) indicates that the product was supplied meeting specifications.2.There is no evidence to suggest that there were any manufacturing issues that contributed to the reported events.3.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 this event happened with the limited information that we received.4.The procedure was completed with the same dislodged stent.5.There was no injury to patient.
Additional Manufacturer Narrative
Device analysis performed on mar 4, 2019.Following the unexpected device arrival and device analysis, final investigation report have been revised and updated accordingly.

• 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: 7653974
• Report Number: 3003084171-2018-00027
• Device Sequence Number: 1550182
• Product Code: NIQ
• UDI-Device Identifier: 07290107013871
• UDI-Public: 07290107013871
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P170008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2018

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: No Information
• Device Expiration Date: 02/29/2020
• Device Model Number: 3.5X15
• Device Catalogue Number: LUN350R15US
• Device Lot Number: LNRUS00128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 07/15/2018; 02/18/2019
• Initial Report FDA Received Date: 07/01/2018
• Supplement Report FDA Received Date: 08/02/2018; 03/12/2019
• 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: Other; Required Intervention
• Patient Age: 84 YR