MAUDE Adverse Event Report: MEDINOL ELUNIR 3.5X15 US; CORONARY DRUG-ELUTING STENT

Model Number	LUN350R15US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Thrombosis (2100)
Date of Event	11/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, four days post stent implantation, patient came in with st elevation myocardial infarction (stemi) due to stent thrombosis.As per the physician evaluation, a 3.5mm x 15mm ridaforolimus eluting (elunir) stent appeared to be adequately opposed but possibly under deployed.The target lesion was the mid-left anterior descending (mlad) artery wherein the device was implanted.A non-cordis stent was placed within the current elunir stent to remove a possible outflow obstruction that may have contributed to in-stent thrombosis.There was a possible proximal edge dissection therefore, additional left anterior descending (lad) non-cordis stent was placed.The product was stored as per the instruction for use (ifu).Thrombosis traveled to obtuse marginalis (om1) artery and circumflex (circ) artery therefore, non-cordis stents were placed in both vessels.The device will not be returned for evaluation as it was implanted.

• Brand Name: ELUNIR 3.5X15 US
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL; 8th hartom st. beck-tech bldg.; jerusalem 97775 08; IS 9777508
• MDR Report Key: 9461390
• Report Number: 1016427-2019-03658
• Device Sequence Number: 19602599
• Product Code: NIQ
• UDI-Device Identifier: 07290107013871
• UDI-Public: 07290107013871
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2019
• Report Date (Section F): 11/17/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: LUN350R15US
• Device Catalogue Number: LUN350R15US
• Device Lot Number: LNRUS00128
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/12/2019
• 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: Life Threatening; Required Intervention
• Date Report Sent to FDA: 11/17/2019