MAUDE Adverse Event Report: MEDINOL ELUNIR 3.0X33 US; CORONARY DRUG-ELUTING STENT

Model Number LUN300R33US

Device Problems Burst Container or Vessel (1074); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: unknown balloon catheter, ge omnipaque contrast, boston indeflator.This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, an elunir 2.0x33 us drug-eluting stent was being deployed in a heavily calcified anterior tibial artery and during inflation the balloon popped, and the stent came off the balloon and had no wall apposition.There was no reported patient injury.The stent was floating in the proximal portion of the at.The operator was able to successfully retrieve the stent through a catheter by using a separate balloon as a snare.There was severe lesion calcification.There was not any vessel tortuosity.There was moderate vessel angulation.The device was being used to treat chronic total occlusion.The product looked normal when removed from its packaging.There was not any difficulty removing the product from the hoop.There was not any difficulty removing the protective balloon cover.There was not any difficulty removing the stylet or any of the sterile packaging components.There were not any kinks or other damages noted prior to inserting the product into the patient.The device did prep normally.The contrast to saline ratio was 30-70.The same indeflator was used successfully with other devices.There was not any resistance/friction while inserting the balloon through the rotating hemostatic valve.There was not any resistance/ friction while inserting the balloon through the guide catheter.The catheter was never in an acute bend.The rupture did not occur while advancing the balloon to the lesion.The maximum inflation pressure was 8 atmospheres (atm).The product was removed intoact from the patient.No other anomalies were noted when the device was removed from the patient.

• Brand Name: ELUNIR 3.0X33 US
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL; 8th hartom st. beck-tech bldg.; jerusalem 97775 08; IS 9777508
• Manufacturer (Section G): MEDINOL; 8th hartom st. beck-tech bldg.; jerusalem 97775 08; IS 9777508
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8767196
• MDR Text Key: 150262175
• Report Number: 1016427-2019-03028
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: LUN300R33US
• Device Catalogue Number: LUN300R33US
• Device Lot Number: LNRUS00204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/10/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1