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

Model Number	3.5X24
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr review performed on june 2, 2019 indicated that the product was supplied meeting specifications.
Event or Problem Description
According to initial report received on may 12, 2019: "runthrough wire went down the artery.Stent went over the wire to the affected area.Stent was difficult to pass the lesion.Stent has a spring coil at the tip of the stent and with the difficult lesion, the coil got wrapped around the wire and due to this, the wire and stent had to be removed.".
Additional Manufacturer Narrative
Correction : following the recipt of additional information listed below the following sections were corrected: section b.1 was updated to include only "product problem" section h.1 was updated to include only "malfunction" additinal informaion recvied from cordis stste that: the report was sent by a case manager within the hospital that did not have all the facts.The spring tip became unraveled while trying to cross and recross a tight lesion.There was no life-threatening incident.The patient was fine.Following the additionla information a revised final report have stated the following conclusions: 1.The review of the dhr (device history record) indicate that the product was supplied meeting specifications.2.The investigation was limited as we did not receive the used product/ angiogram.It is not possible to reach a definite conclusion as to how and why this event happened with the information that we received.3.The event was not life-threatening.There was no injury to the patient.
Additional Manufacturer Narrative
Correction: device arrival not expected.Device is not available for evaluation.Final investigation report issued have stated the following conclusions: the review of the dhr (device history record) indicate that the product was supplied meeting specifications.The investigation was limited since the used product/ angiogram/ additional information were not received.It is not possible to reach a definite conclusion as to how and why this event happened with the received information.

• 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: 8674039
• Report Number: 3003084171-2019-00008
• Device Sequence Number: 2130601
• Product Code: NIQ
• UDI-Device Identifier: 07290107013819
• UDI-Public: 07290107013819
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P170008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 3.5X24
• Device Catalogue Number: LUN350R24US
• Device Lot Number: LNRUS00130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2019
• Supplement Date Received by Manufacturer: 07/18/2019; 09/03/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 08/11/2019; 09/25/2019
• 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: Hospitalization; Life Threatening
• Patient Age: 54 YR
• Patient Weight: 90