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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 3.5X20
Device Problem Insufficient Information (3190)
Patient Problems Chest Pain (1776); Myocardial Infarction (1969)
Event Date 10/25/2019
Event Type  Injury  
Manufacturer Narrative
As the event include information on two (2) sizes of the elunir product and since each mdr present only one (1) product, this report is related to one (1) out of two (2) elunir's products, involved in this event.The second device is included in report 3003084171-2020-00002.Instructions for use and device history records review are anticipated.Procedural cd/angiograms for the case were received and sent for analysis.
 
Event Description
The event occurred as part of medinol's clinical study in (b)(6): elunir ridaforolimus eluting coronary stent system high bleeding risk(hbr) - elunir hbr study.On (b)(6) 2019, the subject underwent the index procedure with implantation of elunir stents (lots lnrin00362 (which is reported under 3003084171-2020-00002) and lnrin00418) to each of the target lesions 1st obtuse margin (95% to 0%) and mid circumflex (70% to 0%) respectively.The guide wire used (unknown brand) for both lesions was with diameter of 0.01.The guide catheter used (unknown brand) in both lesions was with a size of 6f.On (b)(6) 2019, the day following the procedure the subject experienced chest pain associated with elevated troponin at 3539 pg/ml (10-34.20 reference range) and subsiding to 2216 pg/ml on 26 oct 2019 with "no dynamics on ecg".It was determined that the subject suffered a peri-procedural mi.The subject was placed on close observation.No additional intervention was taken for the event.The event resolved without further complaints of angina.The subject was discharged home on (b)(6) 2019.The investigator considered the event of peri-procedural mi moderate in severity and not related to the device or procedure.Baim safety medical review assessment: periprocedural mi possibly related to the device and possibly related to the procedure.It was anticipated due to underlying disease.Following to cec meeting held on (b)(6) 2020 it was decided by the cec members that below listed event is related to study device.
 
Manufacturer Narrative
In the course of the investigation it has been determined that the device described in this report is not related to the event.The event was determined to be associated only to the device described in report 3003084171-2020-00002.
 
Manufacturer Narrative
Angiogram analysis (dated apr.07, 2020) indicated the following: 1.The rca has a 50-70% proximal lesion 2.The lad has mild disease 3.There is tight sub-occlusion of the middle portion of m1 4.There another 70% lesion in the proximal cx 5.At the site of the tight lesion there is a tiny branch, and distal to the lesion is a larger branch measuring 1-1.5mm 6.Balloons are inflated from the proximal cx to distal of the m1 lesion 7.A long stent is implanted and post-dilated in the m1 lesion covering both branches 8.A second stent is placed in the proximal cx 9.Final angiograms show good flow in the cx-m1 branch with no evidence of dissection 10.The tiny branch is occluded and there is narrowing of the second branch.
 
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Brand Name
ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDINOL LTD.
beck tech bldg
8 hartom st.
jerusalem, jerusalem 97775 08
IS  9777508
MDR Report Key9902647
MDR Text Key195095078
Report Number3003084171-2020-00003
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
P170008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Type of Report Initial,Followup,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Model Number3.5X20
Device Catalogue NumberLUN350R20IN
Device Lot NumberLNRIN00418
Was Device Available for Evaluation? No
Date Manufacturer Received03/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age78 YR
Patient Weight90
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