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

Model Number	3.5X20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was re-evaluated on march 29 2018, and assessed as mdr reportable.Device not returned to manufacturer.
Event or Problem Description
Description as reported: the stent balloon on two stents was difficult to remove.According to the physician it felt like the stent balloons were sticking to the stents.The guide was moving back and forth when trying to get the stent balloons out.The physician was able to remove the balloons without a reinflation.No reported patient injury.Additional information received on feb 28, 2018: the physician completed the procedure and deployed the stents; pressures were at least nominal; the physician deployed both stents; he had a difficult time removing both stent balloons after deflation; the stent systems were disposed; the lesion was in the mlad and heavily calcified (2 photos of the lesion were provided); the guide had no kinks; pre-dilatation was done; the stents were not prepped according to ifu; the tech only drew negative once; additional information received on mar 11, 2018: the guide was a vista brite tip, jl3.5.The contrast was measured and did not sit long prior to intervening.Pre-dilatation was with a nc trek 3.0x12.Three inflations at 8 atm for about 15 seconds each.1st elunir 3.5x20 was placed in the mlad on the distal part of the lesion.It was inflated for 31 sec at 12 atm.The 2nd elunir (3.5x 24) was placed proximally and deployed over a 30 sec inflation at 20 atm.The physician did want the proximal lesion to be slightly bigger.He knew at rbp, we became a 3.75.According to the physician the lesion was heavily calcified.He was able to get the stents to go down, but not effortlessly.Additional information received on mar 26, 2018: the wire was a runthroough.The deflation times were only a few seconds.The physician pulled negative on the indeflator a few times to speed up the deflation.He did not mention the wire sticking to the stent outside the body.Also, the tech knew where to hold the delivery system when removing the mandrel.Both stents behaved in the same way.

• 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: 7439130
• Report Number: 3003084171-2018-00008
• Device Sequence Number: 1144295
• Product Code: NIQ
• UDI-Device Identifier: 07290107013833
• UDI-Public: 07290107013833
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/25/2018

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
• Operator of Device: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: 3.5X20
• Device Catalogue Number: LUN350R20US
• Device Lot Number: LNRUS00050
• 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: 03/29/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1