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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDINOL ELUNIR 3.0X17 US; CORONARY DRUG-ELUTING STENT
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MEDINOL ELUNIR 3.0X17 US; CORONARY DRUG-ELUTING STENT Back to Search Results
Catalog Number LUN300R17US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Thrombosis (2100)
Event Date 11/08/2019
Event Type  Injury  
Event Description
As reported, 2 days after the stenting was done, patient came back due to st elevation myocardial infarction stemi and in stent thrombosis was noted.Patient was on antiplatelet drugs previously.The patient then switched to a different anti platelet drug after the procedure.The medication wasn¿t in the body of the patient long enough to cause the elunir stents to shut down.To complete the procedure, non-cordis stents were added and placed in the mid circumflex and mid left anterior descending (lad) artery.The device will not be returned as it is implanted.
 
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Brand Name
ELUNIR 3.0X17 US
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDINOL
8th hartom st. beck-tech bldg.
jerusalem 97775 08
IS  9777508
MDR Report Key9439462
MDR Text Key185812669
Report Number1016427-2019-03636
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Catalogue NumberLUN300R17US
Device Lot NumberLNRUS00275
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/13/2019
Event Location Hospital
Date Report to Manufacturer12/09/2019
Date Manufacturer Received11/13/2019
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 Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention; Disability;
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