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

Model Number 3.5 X 12

Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

The event was reassessed as an mdr following the device analysis report (dated nov.28, 2019), the event classification was updated from: "tracking difficulty over guidewire" to "tracking difficulty over guidewire, damaged spring tip - in patient, stent strut uplift- in patient".Ifu review was conducted and indicated that no deviation of ifu were reported.Overall conclusions from the final report (dated dec.02, 2019): the review of the dhr (device history record), 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 report, the customer complaint was confirmed.It seems that a kink on the guidewire caused the system to lock on the guide wire at the distal fuse.Excessive forces exerted on the system, evidently in attempts to free it from the guidewire, resulted in stent deformation, tip extension and other anomalies.There was no injury to patient.

Event Description

According to initial report received on aug 25, 2019: on (b)(6) 2019, the physician performed a coronary intervention on a (b)(6) female patient.A 3.5 x 12 elunir was selected to treat a coronary lesion.It was explained to the reporter that the stent was prepped in usual fashion in accordance with the elunir ifu, upon placing the stent onto the.014 interventional coronary wire and insertion into the guide catheter, the 3.5 x 12 elunir became stuck on the wire inside of the guide catheter.The scrub tech and the physician were unable to advance the stent on the wire nor remove the stent from the wire.Therefore, the.014 interventional coronary wire along with the 3.5 x 12 elunir were removed as a unit.The vessel was re-wired with a new.014 interventional coronary wire and treated with another stent.There was no patient injury.Additional date received on sep.25, 2019 from cordis - cardinal health co.: the device was stored in the lab, in accordance with the ifu.The product was stored and handled according to the instructions for use (ifu).There wasn't any reported difficulty removing the product from the packaging.There wasn't any damage noted to the product upon inspection prior to use.No kinks/bends were noted in the elunir delivery system before use.The size of the guide catheter that was used during the procedure was 6f and its brand was ebu 4.0 medtronic.The target lesion was lad.The percentage of stenosis can be described as moderate to severe.The device was not used for a chronic total occlusion.The device became stuck on the wire inside of the guide catheter and never reached the lesion nor exited the guide catheter.The device was removed intact (in one piece) from the patient.The patient was stented with another stent and no harm done to him.The event cause an increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.

• Brand Name: ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• Manufacturer (Section G): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• Manufacturer Contact: marina demishtein ; kiryat atidim; bldg. 8; tel aviv, 61581-01 ; IS 6158101
• MDR Report Key: 9508604
• MDR Text Key: 220770664
• Report Number: 3003084171-2019-00021
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07290107013895
• UDI-Public: 07290107013895
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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
• Report Date: 08/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 3.5 X 12
• Device Catalogue Number: LUN350R12US
• Device Lot Number: LNRUS00161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Date Manufacturer Received: 08/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2018
• 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
• Patient Age: 65 YR