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

Model Number ELUNIR 3.5X24

Device Problems Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  malfunction  

Event Description

The following information was received on (b)(6)2024, from the distributor.Lesion : ostial circumflex (moderate calcification) sufficient balloon prep was done with a 3.5 15 ryurei to 12 atm before attempting to cross lesion with an elunir 3.5 24 the elunir was observed not to be manoeuvring as per normal with the operator encountering difficulty passing the stent into the circumflex.Subsequently stent was retrieved and both the distal and proximal stent edges were observed to have been flared / disfigured.The stent was retrieved and will be sent back to medinol for investigation.An elunir 3.5 20 was used after further pre dilation with the 3.5 ryurei and this time it passed into the lesion.Patient is stable.Additional information was received from the distributor on (b)(6) 2024 the following was mentioned: 1.The event caused a significant prolongation of patient hospitalization, but the explanation for the prolongation couldn't be provided.2.The physician couldn't maneuver the system normally and failed to passing the stent into the circumflex.3.No anomalies noted during the device unpackaging.4.The device was prepared normally.5.No resistance/unusaul (abnormal) friction was noticed by the physician, while inserting the balloon through the guide wire.6.No kink of the stent delivery system was noticed during the use by the physician.7.No kinks/bends/damage were exhibited on the guide catheter/guide wire during use.8.The procedural angiogram of the process is not available.Dhr review - (b)(6) 2024 all systems, including stent compliance, were 100% visually inspected at final visual inspection station.The systems successfully passed the release test.

Manufacturer Narrative

Following the device arrival, a device analysis was signed om 21 april 2024 (see enclosed).On 21 april 2024, a review of ifu for customer complaint was performed, no deviation was reported.Final complaint report, signed on 06 may 2024, revealed the following conclusions: a.The review of dhr (device history record) of lot # lnrin0770b indicated that the rpoduct ws supplied meeting the specifications.B.The result of the investigation indicate that the returned product was supplied to the customer meeting specifications.Failure to cross is usually the cosequence of one or a combination of the common issues such as patient anatomy, lesion disposition/composition, operator technique, ancillary equipmentand/or appropriate device selection.No relation was found to medinol's manufacturing process.C.The event of this complaint is addressed in the elunir dfmea report, and the risk remains low.No new risks were identified.D.There was no injury to the patient.

• Brand Name: ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD; bech-tech bldg., har hotzvim b; 8 hartom str.,; jerusalem, israel, isr 97775 08; IS 9777508
• Manufacturer (Section G): MEDINOL LTD; har hotzvim b, bech tech bldg.; 8 hartom str.,; jerusalem, israel 97775 08; IS 9777508
• Manufacturer Contact: marina tikhonov demishtein ; kiryat atidim, bldg., 8; tel aviv, israel 6158101; tel aviv, isr 61581-01 ; IS 6158101
• MDR Report Key: 19087211
• MDR Text Key: 340589602
• Report Number: 3003084171-2024-00002
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SN
• PMA/PMN Number: P170008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2024

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
• Device Operator: Health Professional
• Device Model Number: ELUNIR 3.5X24
• Device Catalogue Number: LUN350R24IN
• Device Lot Number: LNRIN0770B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1