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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 3.5 X 12
Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2019
Event Type  Malfunction  
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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, 97775 08
IS 9777508
Manufacturer (Section G)
MEDINOL LTD.
beck tech bldg
8 hartom st.
jerusalem, 97775 08
IS 9777508
Manufacturer Contact
marina demishtein
kiryat atidim
bldg. 8
tel aviv, 61581-01
IS   6158101
MDR Report Key9508604
Report Number3003084171-2019-00021
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeRP
PMA/PMN NumberP170008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 08/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2020
Device MODEL Number3.5 X 12
Device Catalogue NumberLUN350R12US
Device LOT NumberLNRUS00161
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/31/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/02/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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