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

Model Number	2.75X17
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Several attempts were made to receive additional information via the distributor , yet unfortunately no data was received so far.Device history record (dhr) review performed on (b)(6) 2019 have indicated the product was supplied meeting specifications.
Event or Problem Description
Initial information received from the distributor on (b)(6) 2019 have indicated the physician have attempted to use the system recently and the shaft kinked during insertion.There was no patient injury, and he finished the case with another stent.Further information was available in the detailed complaint report received on (b)(6) 2019 as follows: "as reported by the sales rep, please send a new 2.75x17 elunir to (b)(6) medical center 10019386.Send overnight attention to (b)(6)/cath lab.The dr.Attempted to use this recently and the shaft kinked during insertion." there was no patient injury, and he finished the case with another stent.".
Additional Manufacturer Narrative
Ifu review performed dec 26 , 2019 have indicated: no additional information was received, therefore it's unknown whether there was any deviation/violation of the ifu.Updated device history record review was performed on dec 29, 2019 indicating the product was supplied meeting specifications.Final report, sigend on jan 5, 2020 presented the folowing overall conclusions: 1.The review of the dhr indicates that the product was supplied meeting specifications.It may have been used beyond its expiry date.Considering the fact medinol received this case in early november, there is a possibility that the site has used an expired system.On dec.1, 2019 an attempt was made to obtain the event date, with no success.2.The investigation was limited as we did not receive the used product or additional information.It is not possible to reach a definite conclusion as to how and why this event happened with the information that we received.3.There was no patient injury.Based on cumulative evidence this case was classified with moderate severity.There for, the submitted case was in fact false reporting.The incident didn't cause any serious public health threat, death or serious injury.If the case were to recur it would not be likely to cause or contribute to a death or serious injury.

• Brand Name: ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD; beck-tech bldg.; har hotzvim b, 8 hartom st.,; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 9410117
• Report Number: 3003084171-2019-00013
• Device Sequence Number: 1834787
• Product Code: NIQ
• UDI-Device Identifier: 07290107013628
• UDI-Public: 07290107013628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2019

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: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 2.75X17
• Device Catalogue Number: LUN275R17US
• Device Lot Number: LNRUS00034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1