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

Model Number	2.75X33
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr review performed on dec 18, 2018: the dhr review indicates that the product was supplied meeting specifications.
Event or Problem Description
Initial case report (received from cordis, dec 16, 2018): prior to use in the patients, 3 balloons would not deflate.A notification received from cordis on dec 18, 2018 clarified that the complaint was not as initially reported but as detailed below: "the complaint issue was a "no cross", but when the stent was removed from the patient, a stent strut was sticking up from the stent mid shaft.It was fractured.It was never attempted to be inflated.The patient was not harmed in anyway." updated case report (received from cordis dec 18, 2018): as reported by sales rep: the issue i had with the complaint i submitted was it was a "no cross", but when the stent was removed from the patient, a stent strut was sticking up from the stent mid shaft.It was fractured.It was never attempted to be inflated.The patient was not harmed in anyway.The physician completed the procedure with elunir successfully.Updated case report (received from cordis dec 31, 2018): as reported, an elunir stent delivery system (2.75x33 us) would not cross the lesion.Upon removal from the patient, a stent strut was found to be fractured and sticking up mid-stent.There were no attempts made to inflate the balloon.The procedure was completed using another elunir stent.There was no patient injury reported.The device will be returned for analysis.Updated case report with additional information (received from cordis jan 08, 2019): the target vessel was the circumflex.The vessel was heavily calcified.The vessel was pre-dilated using an unknown balloon.The guide wire used was an xb3.5 cordis guide.There was no guideliner used.There was an angle exiting from the guide.The stent was stored and prepped properly per the instructions for use.
Additional Manufacturer Narrative
Device analysis was performend on jan 28, 2019: device was returned on january 16, 2019.Results of this investigation reveal that the returned product exhibited slight bends in the delivery system and two adjacent uplifted struts.It may be assumed the bends are the result of post procedure handling.Often the used products are "coiled/folded" and "thrusted" into a receptacle in a manner that leads to deformation/bends in the system.Whereas, the customer complaint refers to ".A stent strut was found to be fractured and sticking up mid-stent", it should be noted that no fractured struts were observed, however, two adjacent uplifted struts were observed.The circumstances leading to the strut uplift are unclear, however based on the customer report it may be assumed that it occurred during the procedure handling.The returned product has been investigated and while the relationship between the failure and the device is not clear, the common issues such as patient anatomy, lesion disposition/ composition, operator technique, ancillary equipment (e.G.Guide catheter) and/or appropriate device selection are likely the prominent contributing factors in this event.Results of this investigation together with the customer report indicate that the returned product was supplied meeting specifications.It may be surmised that the observed anomalies are the result of handling during and/or post procedure and the reported complaint is the consequence of one or a combination of common issues indicated above and is not related to medinol's manufacturing processes.Following the device analysis results, complaint classification was re-assessed as sturt uplift.Additional dhr review was issued on jan 30, 2019 in order to capture the updated classification.Ifu review perforemd on jan 30, 2019:: no deviation of ifu was reported.
Additional Manufacturer Narrative
Overall conclusions from final report (feb 10, 2019): 1.The review of the dhr (device history record), the results of device analysis along with additional information received from the customer indicate that the product was supplied meeting specifications.2.According to device analysis report, the reported fractured strut was refuted, however two adjacent uplifted struts were observed.Results of this investigation together with the customer report indicate that the returned product was supplied meeting specifications.It may be surmised that the observed anomalies are the result of handling during and post procedure and the reported complaint is the consequence of one or a combination of common issues (such as patient anatomy, lesion disposition/ composition, operator technique, ancillary equipment and/or appropriate device selection) and is not related to medinol's manufacturing processes.3.Procedure was successfully completed with another elunir stent.4.There was no patient injury.

• 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: 8243014
• Report Number: 3003084171-2019-00001
• Device Sequence Number: 2358193
• Product Code: NIQ
• UDI-Device Identifier: 07290107013666
• UDI-Public: 07290107013666
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2018

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: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 2.75X33
• Device Catalogue Number: LNR275R33US
• Device Lot Number: LNRUS00107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2018
• Supplement Date Received by Manufacturer: 01/16/2019; 02/10/2019
• Initial Report FDA Received Date: 01/13/2019
• Supplement Report FDA Received Date: 02/10/2019; 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR