• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDINOL LTD. ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDINOL LTD. ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 3.0X12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sudden Cardiac Death (2510)
Event Date 04/26/2018
Event Type  Death  
Manufacturer Narrative
Device not returned to manufacturer. Per general instructions - for form fda 3500a medwatch (for mandatory reporting), since the procedure was performed with two (2) devices from two (2) different lots (lnrus00031 and lnrus00037), two (2) separate mdrs were issued. The second lot (lnrus00031) is provided in the mdr under mfr report #3003084171-2018-00021.
 
Event Description
Initial information received (may 04, 2018): a (b)(6) yo female came into the er nonresponsive, dnr. Patient was then sent, intubated, to the cath lab for emergent catheterization. Initial angio revealed totally occluded lad. Physician performed multiple inflation angioplasty with apex 2. 0x12 balloon over a bmw wire. Physician then deployed the 3. 0x12 and the 2. 5x17 elunir, proximal to distal, overlapped, and performed follow up angiography. Physician removed his guidewire, performed another angio and then determined the artery needed a third elunir distal to the two that had been deployed. At that time, thrombus was noted in the midsection of the stented segment, the physician was unable to rewire the lad and the patient succumbed while on the cath lab table. Additional information received (may 27, 2018): dnr
=
do not resuscitate / revive. The products were stored properly according to the instructions for use (ifu). The products were prepped according to instructions for use (ifu). The patient came to cath lab on heparin iv 100 units / hour. And additional 2000 units of heparin were administered during the procedure. Two acts were performed: 240 and 300. The patient prediagnosis was hypertension, chf and cva. The patient came to cath lab with st elevation mi. Totally occluded lad. There was no note on difficulty delivering the first two stents. The deployed stents order was proximal to distal. Post dilation was performed. The angiographic result of the first 2 stents was satisfactory. The physician did not note the thrombosis on the follow up angiogram performed before the wire was removed. The physician remove the wire after the first two stents since he felt he was finished with the intervention of the lad. The 3rd stent was required since the physician did angio after the wire was pulled and noted a third lesion, distal, that he felt needed another stent. The physician fail to rewire the lad since it began shutting down. Cardiac arrest was the cause of death. The angiographic results are not available for review. Per general instructions - for form fda 3500a medwatch (for mandatory reporting), since the procedure was performed with two (2) devices from two (2) different lots (lnrus00031 and lnrus00037), two (2) separate mdrs were issued. The second lot (lnrus00031) is provided in the mdr under mfr report #3003084171-2018-00021.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7555851
MDR Text Key109609452
Report Number3003084171-2018-00022
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 05/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/30/2019
Device Model Number3.0X12
Device Catalogue NumberLUN300R12US
Device Lot NumberLNRUS00037
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2017
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: 05/31/2018 Patient Sequence Number: 1
-
-