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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 3.0X33
Device Problems Fracture; No Apparent Adverse Event
Event Date 09/06/2018
Event Type  Injury  
Manufacturer Narrative

Device is not available for analysis. Dhr review was done (september 20, 2018): the review of the dhr (device history record) indicates that the product was supplied meeting specifications.

 
Event Description

Description of complaint as received from cordis (september 06, 2018): the event occurred at (b)(6) hospital, (b)(6). "today there was a case at kings mill hospital in which an elunir was implanted and when the balloon deflated the physician suspected stent fracture. After using stent boost you can see the stent is severely fractured. From my understanding it was a type a, straight forward lesion with no heavy calcification that would cause concern and nothing that the physician could attribute the fracture to. He took another elunir and stented inside the fractured stent and the vessel appeared patent. I think he would have been reluctant to use another elunir but his rationale was that he didn't want to mix drugs / polymer types in the same vessel". Additional information received from medinol's product manager (september 06, 2018): 1. Direct stenting to mid-circ. 2. Elunir 3. 0x33 was placed. 3. After deployment and deflation the physician suspected a fracture, he then used a stent boost. 4. The stent was post dilated and another elunir stent was placed, the rep think it was a 3. 5x8 but he will verify. 5. Lesion was de novo. 6. No tracking difficulty. 7. A full report would be sent in an hour or so. 8. They will try and get the guiding catheter. Procedure details report was received from cordis (september 06, 2018). Additional information received: information received from the physician who treated the patient (provided by cordis, september 12, 2018): "i have also reviewed case with another physician and he also feels it's very rare to see this in sort of situation. The lesion was pre-dil with 2. 5 balloon and deb was used for other side branch which was distance from distal landing zone of main vessel. The proximal vessel was good calibre and at least 3. 75, as compare to distal landing zone 3. 0 just above the bifurcation which it treated with deb. I post dilated the stent just above the distal edge with 3. 75nc with 12-14 atm, and when brought balloon back to do mid and prox, noted on stent boost the fracture. There is no other stent in the vessel before and no isr. This is unusual event as having used all the latest stent in european market and deployed 2000-2500 stents in last 2 years, never experienced or caused any fracture angiographically". Analysis of currently available information by medinol's interventional cardiologist (september 13, 2018): "without seeing the angiogram i can deduce that this was a severe lesion, definitely not a straightforward type a lesion. Predilation was only performed with nc balloons, a cto wire (fielder) was used to cross, not a simple case. The patient also has a cto in the lad. When treating such severe lesions, stent fractures are to be expected from time to time. Post dilating with a nc balloon that is 0. 75 mm larger than the stent is very unusual, it is stated that the fracture was noted before post-dilation, but it is possible that this aggressive post dilation made the situation worse. I will be able to make more detailed comments if i see the angiogram". ,.

 
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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, israel 97775 08
IS  9777508
Manufacturer (Section G)
MEDINOL LTD.
beck tech bldg
8 hartom st.
jerusalem, israel 97775 08
IS  9777508
Manufacturer Contact
marina tikhonov demishtein
kiryat atidim
bldg. 8
tel aviv,  61581-01
  6158101
MDR Report Key7913930
Report Number3003084171-2018-00043
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3.0X33
Device Catalogue NumberLUN300R33CE
Device LOT NumberLNRCE00143
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/17/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/27/2018 Patient Sequence Number: 1
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