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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDINOL ELUNIR 3.0X28 US CORONARY DRUG-ELUTING STENT

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MEDINOL ELUNIR 3.0X28 US CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number LUN300R28US
Device Problems Stent; Difficult To Position; Device Dislodged or Dislocated; Catheter
Event Date 05/08/2018
Event Type  Injury  
Manufacturer Narrative

Pursuant to the fda code of federal regulations, (b)(4) is an importer of elunir, a imported product made by medinol.  therefore, (b)(4) is required to report all complaints of deaths and serious injuries to the fda associated with this product.

 
Event Description

During use, it was reported that the 3. 0 x 28 mm elunir stent delivery system (sds) would not cross the lesion. The stent dislodged from the balloon and a unknown balloon was advance to the lesion to deploy the elunir stent. There was no patient injury. The procedure was completed successfully. The first 3. 0 x 28 mm elunir sds would not cross the mid right coronary artery (rca). After repeated attempts to cross the lesion the elunir sds was retracted back into the competitor's 6f guide catheter. Then it was noted that the elunir stent slipped off the stent delivery balloon and the stent remained in the guide catheter. The sds was removed out of the guide and a 1. 5 unknown balloon was advanced over the. 014 competitor's guide wire and through the undeployed elunir. The elunir was repositioned in the proximal rca and deployed using the 1. 5 unknown balloon. A 2. 0 and 3. 0 nc unknown balloon were used to further dilate the elunir. Once the stent was well apposed to the vessel wall the physician used a 3. 0 x 24 mm elunir distal to the 1st and 3. 0 x 20 mm elunir proximal. There was no excess force used during prep. There was no difficulty removing the device from the packaging. There was no resistance/friction while inserting or retracting the balloon through the guide catheter. There were no kinks or other damages noted prior to inserting the product the product into the patient. The device was stored on a cart for a few days. The device is available for analysis. No other information was provided.

 
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Brand NameELUNIR 3.0X28 US
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDINOL
8th hartom st. beck-tech bldg.
4th floor, p.o.b. 45026
jerusalem 9777508
IS 
MDR Report Key7569284
Report Number1016427-2018-01520
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2019
Device MODEL NumberLUN300R28US
Device Catalogue NumberLUN300R28US
Device LOT NumberLNRUS00080
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/23/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/09/2018
Device Age6 mo
Event Location Hospital
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/05/2018 Patient Sequence Number: 1
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