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	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
The obtuse marginal contained some mild to moderate tortuosity (proximal to the lesion site) and a moderate to severe calcified stenotic lesion.Intervention ensued and the lesion site was pre-dilated with a 3.0 trek semi-compliant balloon prior to placement of a 3.5 x 33 elunir stent.The stent delivered without difficulty through a 6f ebu guiding catheter (engaged coaxially to the left main) to the site of the stenotic lesion and was deployed at nominal pressure (10 atm).Post-deployment of the elunir, after deflation of the balloon, the physician experienced mild to moderate difficulty removing the balloon.To assist with removal of the balloon, it was suggested pulling negative twice to return the balloon to its smallest post-deployment profile.After successful removal of the balloon, the physician verbalized the mild to moderate difficulty he experienced while removing the balloon post deployment of the elunir.No patient injury reported.Additional information received in march 19, 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; no difficulty was noted during removal of the product from the packaging; no re-sterilized products were used; the device was prepped according to the instructions for use (ifu); no anomalies were noted; the guide wire lumen was flushed prior to loading the delivery system onto the guide wire; it was verified that the stent was contained within the outer portion of the balloon prior to insertion and deployment; the guide wire lumen was flushed with the tool provided prior to loading the delivery system onto the guide wire according to the indications for use (ifu); the stent was deployed at nominal pressure.The delivery system and the balloon were removed intact from the patient post deployment of the stent with mild to moderate difficulty; the balloon and delivery system were discarded.

• 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: 7395311
• Report Number: 3003084171-2018-00007
• Device Sequence Number: 10901438
• Product Code: NIQ
• UDI-Device Identifier: 07290107013765
• UDI-Public: 07290107013765
• 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): 03/14/2018

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: 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: 03/14/2018
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1