MAUDE Adverse Event Report: MEDINOL ELUNIR 3.0X28 US; CORONARY DRUG-ELUTING STENT

Model Number LUN300R28US

Device Problems Difficult To Position (1467); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

Pursuant to the fda code of federal regulations, (b)(4) is an importer of elunir, a imported product made by medinol. therefore, (b)(4) is required to report all complaints of deaths and serious injuries to the fda associated with this product.

Event Description

During use, it was reported that the 3.0 x 28 mm elunir stent delivery system (sds) would not cross the lesion.The stent dislodged from the balloon and a unknown balloon was advance to the lesion to deploy the elunir stent.There was no patient injury.The procedure was completed successfully.The first 3.0 x 28 mm elunir sds would not cross the mid right coronary artery (rca).After repeated attempts to cross the lesion the elunir sds was retracted back into the competitor's 6f guide catheter.Then it was noted that the elunir stent slipped off the stent delivery balloon and the stent remained in the guide catheter.The sds was removed out of the guide and a 1.5 unknown balloon was advanced over the.014 competitor's guide wire and through the undeployed elunir.The elunir was repositioned in the proximal rca and deployed using the 1.5 unknown balloon.A 2.0 and 3.0 nc unknown balloon were used to further dilate the elunir.Once the stent was well apposed to the vessel wall the physician used a 3.0 x 24 mm elunir distal to the 1st and 3.0 x 20 mm elunir proximal.There was no excess force used during prep.There was no difficulty removing the device from the packaging.There was no resistance/friction while inserting or retracting the balloon through the guide catheter.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device was stored on a cart for a few days.The device is available for analysis.No other information was provided.

• Brand Name: ELUNIR 3.0X28 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 9777508 ; IS
• MDR Report Key: 7569284
• MDR Text Key: 110083968
• Report Number: 1016427-2018-01520
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• 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 Model Number: LUN300R28US
• Device Catalogue Number: LUN300R28US
• Device Lot Number: LNRUS00080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/09/2018
• Device Age: 6 MO
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention