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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 3.5X15
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Insufficient Information (3190)
Patient Problems Intimal Dissection (1333); Myocardial Infarction (1969); Thrombosis (2100)
Event Date 11/09/2019
Event Type  Injury  
Manufacturer Narrative
Device history record review indicated the device was supplied meeting specifications.
 
Event Description
Initial description was obtained on nov 17, 2019 as follows: as reported, patient came in with a stemi on (b)(6) 2019 due to in stent thrombosis. Per evaluation from physician elunir stent appeared to be adequately apposed but possibly under deployed. A different stent was placed within current elunir stent to remove possible outflow obstruction that may have contributed to in stent thrombosis. There was a possible proximal edge dissection so additional lad stent was placed. Thrombosis traveled to om1 and circ so stents were placed in both vessels. Product malfunction/failure mode as reported: inaccurate placement: the stent is deployed in the wrong location or does not fully cover the target lesion. Vessel: mid left anterior descending. Additional information received from distributor on dec 3, 2019 stated as follows: the device stored and handled as per the instruction for use (ifu). No damage was noted to the packaging of the device. The device prep as per the ifu one stent was implanted. The patient did not have any medical history found relevant for this case (e. G. Bleeding disorder, coronary artery disease. ) the site pre-dilated prior to stent placement: 10atms for 15 seconds. Inflation pressure was used to deploy the stent: 12atms for 40 seconds. Good wall apposition was observed via angio. Patient is currently doing fine.
 
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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 Key9458540
MDR Text Key185931552
Report Number3003084171-2019-00019
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
P170008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2020
Device Model Number3.5X15
Device Catalogue NumberLUN350R15US
Device Lot NumberLNRUS00128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/12/2019 Patient Sequence Number: 1
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