MAUDE Adverse Event Report: MEDINOL UNKNOWN ELUNIR; CORONARY DRUG-ELUTING STENT

Catalog Number UNK-ELUNIR

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  Injury  

Event Description

As reported, the physician was intending the elunir 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.There was no reported patient injury.The target lesion the distal-circumflex.The vessel level of angulation and calcification is none.The vessel level of tortuosity is mild.The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the device.There were no kinks or other damages noted prior to inserting the product into the patient.The product was prepped according to the instructions for use (ifu).There was no excessive force applied on the stent delivery system while inserting it over the guide wire.The stent did not kink while being used.There was no difficulty crossing the lesion.The stent was never in acute angle.The patient went home that same day.There is no procedural cd available for review.Additional information received indicates that a 6f cordis xb3.5 was used in the procedure.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was no excessive force used anytime during the procedure.A non-cordis closure device was used to complete the procedure.The procedure was successful.

• Brand Name: UNKNOWN ELUNIR
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL; 8th hartom st. beck-tech bldg.; 4th floor, p.o.b. 45026; jerusalem 97775 08; IS 9777508
• MDR Report Key: 8374081
• MDR Text Key: 137274931
• Report Number: 1016427-2019-02564
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-ELUNIR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TR BAND (CLOSURE DEVICE)
• Patient Outcome(s): Hospitalization