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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
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/27/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device not returned to manufacturer; dhr review is attached.
 
Event or Problem Description
The 3.5x20 stent stripped off the balloon, then the physician struggled to find where the stent went, then ultimately once found it, it was way past target lesion and had to crush stent up against the lad.
 
Event or Problem Description
Additional information (05-mar-2018): no patient injury had occurred.
 
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Brand Name
ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
Common Device Name
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDINOL LTD.
beck tech bldg
8 hartom st.
jerusalem, 97775 08
IS  9777508
MDR Report Key7380751
Report Number3003084171-2018-00004
Device Sequence Number13704926
Product Code NIQ
UDI-Device Identifier07290107013833
UDI-Public07290107013833
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P170008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Expiration Date10/31/2019
Device Model Number3.5X20
Device Catalogue NumberLUN350R20US
Device Lot NumberLNRUS00050
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/07/2018
Supplement Date Received by Manufacturer04/22/2018
Initial Report FDA Received Date03/29/2018
Supplement Report FDA Received Date05/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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