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

Model Number 3.0X28

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Device analysis report - following the conclusion arising from the device analysis report, confirming the leak in the rx port (stent delivery system), the event was re-evaluated on (b)(6) 2018 and assessed as "mdr-reportable".(b)(4).

Event Description

The event took place on (b)(6) 2018.The physician placed the stent mounted balloon catheter into the prox lad and when he went to deploy the stent the balloon would not hold consistent pressure.It did inflate enough to deploy the stent and he post dilated with the same balloon to ensure deployment, but it did the same thing.It also would not deflate completely.Once the balloon catheter was outside the body and the staff made sure the stent was deployed in the proper place, they check the balloon.Upon inspection, they observed the balloon was intact (not ruptured) but they noticed a small leak where the balloon catheter is mounted onto the wire shaft.It was visible when the balloon was inflated.Additional information received on (b)(6) 2018: there was no injury to the patient.Additional information received from the distributor on may 27, 2018: the product was stored properly according to the instructions for use (ifu).No damage was noted to the product packaging upon inspection prior to use.The rx port appeared normal.There was no difficulty removing the product from the packaging.Neither the product, nor any of the other devices used with it, had been re-sterilized.The device was prepped according to instructions for use (ifu).Pre-dilation was not performed.No anomalies were noted during or after the device was prepped.The balloons inflation pressure attempted to go to nominal 10 atm, but balloon would not hold pressure so dr.Runquist took it higher, approx.14 atm.The balloons deflation pressure is not certain, they were unable to completely pull a complete negative once stent was deployed.Deflation occurred in approx.30 seconds.The target lesion was prox lad approx.85%.The lesion calcification was little or none.There was no vessel tortuosity.There was no vessel angulation.There was as an adequate continuous flush maintained through all devices.There was no difficulty tracking the stent through the vessel or lesion.There was no kink/bent noted prior to inserting the product into the patient.There was no kink/bent noted after devices were removed from patient.No damage appeared to the stent.It was deployed in the proper place.There was no unusual force used at any time during the procedure.The device was removed intact (in one piece) from the patient.The product will be returned for analysis.Dhr review was performed - ((b)(6) 2018) - all manufacturing and release test documentation is present and meets requirements.Crimping, crossing profile, and securement measurements are all in compliance with requirements.All the released systems met specifications.Ifu review was performed - ((b)(6) 2018) - no deviation of ifu was reported.Device analysis report - (received on june 25, 2018) - overall conclusions arising from the device analysis: the review of the dhr (device history record) together with the customer report indicates that the product was supplied meeting specifications.There is no evidence to suggest that there were any manufacturing issues that contributed to the reported events.Based on the device analysis investigation together with the customer report indicate that the reported system leak was confirmed.However, the cause/circumstances for the leak in the rx port region are unclear.No anomalies were detected that could elucidate the circumstances for the customer reported failure.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.; beck tech bldg; 8 hartom st.; jerusalem, israel 97775 08; IS 9777508
• Manufacturer (Section G): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, israel 97775 08; IS 9777508
• Manufacturer Contact: marina tikhonov demishtein ; kiryat atidim; bldg. 8, p.o.b. 58165; tel aviv, 61581-01 ; IS 6158101
• MDR Report Key: 7669089
• MDR Text Key: 113391702
• Report Number: 3003084171-2018-00029
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07290107013994
• UDI-Public: 07290107013994
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 3.0X28
• Device Catalogue Number: LUN300R28US
• Device Lot Number: LNRUS00080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2017
• 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