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

Model Number	2.5X24
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Stenosis (2263)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
The physician deployed the first stent (2.5x12) in the mid circumflex artery.He did not post dilate the stent, after stent placement.The stent placement was over a bend.Both the lad and circumflex had substantial disease through out.He then wanted to stent the distal circumflex artery.As he tried to pass the 2.5x24mm stent through the first stent, he managed to strip the second stent off the catheter.The two stents were both retrieved with a snare.Patient is stable not with a partially open circumflex.The circumflex before the intervention had about 70% blockage.Additional information received on feb 28, 2018.The length of the lesion was at least 36mm.The site was predilated prior to stent implantation.There was diffuse disease.The stent that was dislodged wasn't manipulated during prep.Sheath: 6fr.Guide catheter size: 6fr guide jl4.The balloon wasn't partially inflated.The inflation device was in the negative position while being advanced and removed.Status of the patient: stable.The target lesion was not successfully treated.
Additional Manufacturer Narrative
Type of reportable event was changed from "malfunction" to "serious injury".
Event or Problem Description
Information received on feb.27, 2018: · the device problem occurred during the procedure.· the product was stored as per labeling.· there was no injury to patient.

• 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: 7353054
• Report Number: 3003084171-2018-00003
• Device Sequence Number: 1741122
• Product Code: NIQ
• UDI-Device Identifier: 07290107013567
• UDI-Public: 07290107013567
• 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,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: 2.5X24
• Device Catalogue Number: LUN250R24US01
• Device Lot Number: LNRUS00053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/23/2018
• 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: Required Intervention