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U.S. Department of Health and Human Services

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

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MEDINOL ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT Back to Search Results
Catalog Number LUN300R33US
Device Problems Stent; Fracture
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.

 
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Brand NameELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceCORONARY 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 Key7934056
Report Number1016427-2018-01903
Device Sequence Number1
Product CodeNIQ
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 Received10/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberLUN300R33US
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2018
Distributor Facility Aware Date09/06/2018
Event Location Hospital
Date Report TO Manufacturer10/04/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/04/2018 Patient Sequence Number: 1
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