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

Catalog Number LUN300R33US

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  Injury  

Event Description

As reported, an elunir 3.0x33 was implanted and when the balloon deflated the physician suspected that the stent fractured.There were no reported patient injuries.After using the stent boost it was noted that the stent was severely fractured.The physician took another elunir and stented it inside the fractured stent and the vessel appeared to be patent.This was a type a, straight forward lesion with no heavy calcification that would cause concern and nothing that the physician could attribute the fracture to.The lesion was pre-dilated with an unknown 2.5 x20 balloon.A drug eluting balloon (deb) was then used for the other side branch which was some distance away from the distal landing zone of the main vessel.The proximal vessel was good calibre and at least 3.75, as compared to the distal landing zone of 3.0 just above the bifurcation which it treated with deb.The stent was post dilated just above the distal edge with 3.75nc at 12-14 atm.Then the balloon was brought back to the middle and proximal positions, and the fracture was noted on the stent boost.There was not an older stent implanted in the patient and there was no in-stent restenosis.Additional procedural details were requested but are unknown.

• Brand Name: ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• 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: 7934056
• MDR Text Key: 122665025
• Report Number: 1016427-2018-01903
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/27/2018,10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LUN300R33US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2018
• Distributor Facility Aware Date: 09/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2018
• 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): Life Threatening; Required Intervention