MAUDE Adverse Event Report: MEDINOL ELUNIR 2.5X15 US; CORONARY DRUG-ELUTING STENT

Catalog Number LUN250R15US

Device Problems Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2018

Event Type  Injury  

Event Description

As reported, during a percutaneous coronary intervention (pci), the elunir 2.5 x 15 us stent delivery system (sds) dislodged and was deployed in the left anterior descending (lad).Another stent was used.The patient was not hurt/there was no reported patient injury.Additional information received indicated that the physician was not able to cross the intended target lesion with the sds, so he pulled it back to the guide catheter but the stent dislodged before it reached the guide.The stent was hanging in the lad, so he used another balloon to deploy it in the lad.The target lesion for the procedure was the first diagonal.The lesion was reported to be: a 95% stenosis, severely calcified, and not tortuous.Another elunir stent was used to successfully treat the fist diagonal target lesion.The procedure was completed successfully without patient injury.The concomitant products used: sheath, guiding catheter and guidewire were non-cordis products.The sds is not being returned for inspection.No patient information was available.The product was prepped properly per the ifu with no problems noted during preparation.There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.During prep, the stent was manipulated.The stent was properly mounted on the system when inspected prior to use.There were no kinks or other damages noted prior to inserting the product into the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.The catheter was not ever in an acute bend.No excessive force was used anytime during the procedure.The access site was femoral.The patient¿s status was discharged.Procedural films are not available.No additional information is available.Concomitant products: csi: 6 fr.Merit; gw: abbott bmw; gc: 6 fr.Medtronic.

• Brand Name: ELUNIR 2.5X15 US
• 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: 7864524
• MDR Text Key: 119826588
• Report Number: 1016427-2018-01792
• 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
• Type of Report: Initial
• Report Date: 09/11/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: LUN250R15US
• Device Lot Number: LNRUS00076
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2018
• Distributor Facility Aware Date: 08/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• 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
• Patient Outcome(s): Life Threatening; Required Intervention