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

Model Number	3.5X33
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
The physician implanted two elunir, upon the deployment of the second stent, he encountered significant resistance in removing the balloon.His take was the balloon was stuck on the wire.Eventually, the clinician removed the wire and balloon and unfortunately upon doing first this, lost flow in the lad.The patient ended up going to surgery and is now stable.Additional information received on mar 20, 2018, from the operator: the lesion was a proximal / mid lad lesion; the first elunir was placed distally (mid lad) with no difficulty; the more proximal lesion was a simple type a lesion.It was easy to cross and easy to pre-dilate; the wire used was a bmw universal; a guideliner was also used.A 3.5x17 mm elunir stent was inserted without difficulty; pressure was neutral during insertion; stent was deployed at nominal pressure (10 atm).Sds deflation was normal and the operator was sure that the balloon deflated fully; upon attempting to remove the sds, it would not move without the guidewire; ultimately, the sds was removed together with the stent.Immediately afterwards, the lad became occluded; operator does not know whether this was due to a dissection or to thrombus, but believes the latter as the patient was noted to have clots in the lad beforehand.Patient was sent to emergency surgery and is doing fine.Catheter was not saved.

• 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: 7391369
• Report Number: 3003084171-2018-00005
• Device Sequence Number: 11020497
• Product Code: NIQ
• UDI-Device Identifier: 07290107013765
• UDI-Public: 07290107013765
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/11/2018

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: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: 3.5X33
• Device Catalogue Number: LUN350R33US
• Device Lot Number: LNRUS00058
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2018
• Initial Report FDA Received Date: 04/03/2018
• 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: Hospitalization; Required Intervention