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

Model Number	2.75X20
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
The tech removed stent from sterile packaging.Upon examining the stent before insertion, the tech noticed that stent had a malformation.A stent strut had fractured and was sticking out from body of the stent.The physician took a clean dry gauze and ran it back the stent to see if the strut was part of the stent.The malformation strut grabbed the gauze and the physician did not use the stent.Additional information received on april 11th, 2018: no excessive force was applied to the device during preparation.The tech did not touch the stent area.The stent was damaged approximately in the middle of it.The product was stored properly, according to ifu.The packaging was inspected prior to use and no damage was noted.There was no difficulty removing the product from the packaging.
Event or Problem Description
Additional information received: 1.Ifu review (may 22, 2018) - no deviation of ifu was reported.2.Device analysis ((b)(6)) - the reported "fractured" stent strut was ascertained not to be broken or cracked, but an uplifted strut.While it is evident that the strut uplift occurred post stent integration, no conclusion can be made as to when and under what circumstances stent deformation/ strut uplifting occurred.3.Final report (may 28, 2018) - while no definite conclusion can be made as to the circumstances of the reported failure, there are no signs of any product manufacturing issues.It has been suggested that the strut uplift may have occurred during the remove of the shipping mandrel while pressing the sleeve.
Additional Manufacturer Narrative
(b)(4).

• 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, israel 97775 08; IS 9777508
• MDR Report Key: 7482397
• Report Number: 3003084171-2018-00017
• Device Sequence Number: 13817162
• Product Code: NIQ
• UDI-Device Identifier: 07290107013635
• UDI-Public: 07290107013635
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 04/08/2018

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: 2.75X20
• Device Catalogue Number: LUN275R20US
• Device Lot Number: LNRUS00042
• 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: 04/08/2018
• Supplement Date Received by Manufacturer: 05/06/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1