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U.S. Department of Health and Human Services

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

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MEDINOL LTD. ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 3.0X24
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100)
Event Date 12/22/2018
Event Type  Injury  
Manufacturer Narrative
Instructions for use and device history records review are anticipated.
 
Event Description
The event became known as part of the protocol binding, routine periodic follow up for patients participating in bionics clinical trial. The following description was received from the medical center in (b)(6): on (b)(6) 2018, the subject experienced st elevation myocardial infarction- anterior wall and was hospitalized. It was reported that the subject experienced painful pressure in his chest in the evening of his admission and therefore the subject was taken to the hospital. An electrocardiogram revealed st elevation. On (b)(6) 2018, high sensitive cardiac troponin (ctnl 2016) was 20191 ng/l (n: 0-35). The subject was treated with a loading dose of aspirin and heparin and was brought directly to the catheterization room. A lesion was noted in the distal left anterior descending artery (lad) which was 100% stenosed. The subject underwent successful percutaneous coronary intervention with drug-eluting balloon (deb) to the distal lad. On (b)(6) 2018, the event was considered resolved and the subject was discharged to home in stable condition. The investigator assessed the st elevation myocardial infarction- anterior wall as possibly related to study device. The medical safety reviewer agrees/concurs with the investigator's assessment. The sae was filed as an official complaint following cec adjudication on (b)(6) 2020, relating the device to the event.
 
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Brand NameELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDINOL LTD.
beck tech bldg
8 hartom st.
jerusalem, jerusalem 97775 08
IS 9777508
Manufacturer (Section G)
MEDINOL LTD.
beck tech bldg
8 hartom st.
jerusalem, jerusalem 97775 08
IS 9777508
Manufacturer Contact
marina demishtein
kiryat atidim
bldg. 8
tel aviv, 61581-01
IS   6158101
MDR Report Key9975732
MDR Text Key191867480
Report Number3003084171-2020-00006
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
P170008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/26/2014
Device Model Number3.0X24
Device Catalogue Number482300240100RD
Device Lot NumberDES0279
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/19/2020 Patient Sequence Number: 1
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