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

Model Number	3.5X33
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dhr review was conducted on feb.21st, 2019.It indicates that the product was supplied meeting specifications.
Event or Problem Description
The initial report was received from the distributer on feb.6th, 2019: "from what i understand the doctor was intending the stent to be deployed in a distal lesion and instead the stent stripped off from the balloon catheter in the proximal part of the vessel at which point had to be deployed in that location the device was prepped according to ifu.There was no patient injury" the total implanted quantity is 1.Additional information was received on feb.13th, 2019: the target lesion was distal circ.The lesion wasn't calcified.There was little vessel tortuosity.There wasn't any vessel angulation.The product was stored, handled and prepared according to the ifu.There wasn't any excessive force applied on the stent delivery system while inserting it over the guide wire.The stent didn't kink while being used.There wasn't any difficulty crossing the lesion.The stent wasn't ever in an acute bend.There wasn't any damage noted to the packaging of the device, nor kinks or other damages noted prior to inserting the product into the patient.The patient went home that same day.Additional information was received on feb.17th, 2019: the procedure was successful.The wire brand is unavailable.The guide catheter that was used was cordis 6f xb3.5.There wasn't any resistance/friction while inserting the balloon through the rotating hemostatic valve.There wasn't any resistance/friction while inserting the balloon through the guide catheter.There wasn't any excessive force used anytime during the procedure.
Additional Manufacturer Narrative
Ifu review was preformed and no deviations from the ifu were reported.Device analysis is attached.Conclusions of the final report of the complaint investigation: 1.The review of the ohr (device history record) indicates that the product was supplied meeting specifications.2.There is no evidence to suggest that there were any manufacturing issues that contributed to the reported event.3.According to the device analysis report, the returned product was received lacking the stent on the delivery system which concurs with the customer complaint.However, the circumstances leading to the reported stent dislodgement are unclear.Based on this investigation and the customer report no evidence-based conclusion can be made as to the circumstances for the reported complaint.4.There was no injury to patient.No corrective action is required for this complaint.

• 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: 8377031
• Report Number: 3003084171-2019-00005
• Device Sequence Number: 2977655
• Product Code: NIQ
• UDI-Device Identifier: 07290107013765
• UDI-Public: 07290107013765
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: 04/30/2020
• Device Model Number: 3.5X33
• Device Catalogue Number: LUN350R33US
• Device Lot Number: LNRUS00173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/28/2019
• 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: Required Intervention