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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 3.5X38MM
Device Problem Failure to Unfold or Unwrap (1669)
Patient Problems Chest Pain (1776); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100); Stenosis (2263)
Event Date 09/28/2019
Event Type  Injury  
Manufacturer Narrative
Instructions for use and device history records review are anticipated. Angiogram analysis is anticipated.
 
Event Description
The event occurred in (b)(6) as part of (b)(6) clinical study: elunir ridaforolimus eluting coronary stent system high bleeding risk (hbr) - (b)(6) study. On (b)(6) 2019 the subject was admitted to the hospital with acute coronary syndrome and st-elevation myocardial infarction (stemi). Coronary angiography showed a diseased vessel in the rca/rpda/rpl. Index procedure was on (b)(6) 2019 with implantation of an elunir stent (lot# lnrce00337) to the proximal rca and a second stent (lot# lnrce00225) to the distal rca, both target lesions. On (b)(6) 2019, approximately 4 days post index procedure, the subject experienced chest pain and on admission was found to be in complete av block with st elevation in ii, ii, avf (stemi). The subject underwent emergent pci with angiography showing 100% stenosis of mid rca. Ivus showed the proximal portion of the 3. 5x38mm stent (lot# lnrce00337) was under deployed. Thrombus was also seen. The event is associated only with the proximal rca implanted stent, size 3. 5x38mm (lot# lnrce00337). Actions taken following the event were as follows: infusion of intracoronary glycoprotein iib/iiia (gp iib/iiib) inhibitor was initiated. An export catheter was used but only minimal thrombus was aspirated. The subject received additional gp iib/iiib. Coronary revascularization to the mid rca with pre-dilatation and drug eluting balloon to the stent was performed. The stenosis resolved to 0% with restoration of coronary flow. The subject converted from complete heart block to sinus tachycardia with resolution of st elevation. (related sae#2- inferior st segment elevation myocardial infarction). The subject received a loading dose of ticagrelor 180 mg. He was previously on dapt (clopidogrel and aspirin) and this was switched to ticagrelor plus aspirin. Post procedure troponin was 602 ng/l (1130 ng/l on (b)(6) 2019 from a previous hospital discharge). On (b)(6) 2019 ekg showed inferior q-wave and t-wave inversion. The subject was also noted to have bibasilar crepitus. He was started on furosemide 40 mg daily and bisoprol was increased to 5 mg daily post mi. On (b)(6) 2019 his echocardiogram showed moderate ejection fraction between 40-45%. His furosemide was discontinued and was discharged home on (b)(6) 2019. Patient outcome: recovered. The investigator considered the event of stent thrombosis and consequent inferior stemi severe, not related to the procedure, related to the device and resolved on (b)(6) 2019. Initial assessment by (b)(6) medical reviewer: stent thrombosis of the right coronary artery possibly related to the device and the procedure. It will be confirmed by the cec and review of the angiographic data. It was anticipated but will be referred to the cec. Following to cec meeting held on (b)(6) 2020 it was decided by the cec members that the tevent is related to study device.
 
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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.
har hotzvim b, 8 hartom st.,
jerusalem, 97775 08
IS 9777508
Manufacturer (Section G)
MEDINOL LTD
beck-tech bldg.
har hotzvim b, 8 hartom st.,
jerusalem, 97775 08
IS 9777508
Manufacturer Contact
marina demishtein
kiryat atidim
bldg. 8, p.o.b. 58165
tel aviv, 61581-01
IS   6158101
MDR Report Key9915257
MDR Text Key196795986
Report Number3003084171-2020-00005
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUK
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 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2020
Device Model Number3.5X38MM
Device Catalogue NumberLUN350R38CE
Device Lot NumberLNRCE00337
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2018
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: 04/02/2020 Patient Sequence Number: 1
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