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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO NC SOLARICE RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

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MEDTRONIC MEXICO NC SOLARICE RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Catalog Number NCSLC4020X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 04/26/2021
Event Type  Injury  
Manufacturer Narrative
Title: stent underexpansion due to heavy calcification in a patient with recent acute coronary syndrome successfully treated with lithotripsy authors: rafal januszek, stanislaw bartus journal: clinical vignette issue: 7-8 ref: doi: 10. 33963/kp. 15970. Date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article titled - stent underexpansion due to heavy calcification in a patient with recent acute coronary syndrome successfully treated with lithotripsy - was submitted for review. This article is a case study of a patient who presented to hospital with acute coronary syndrome. Coronary angiography (ca) of the right coronary artery (rca) revealed an edge in-stent restenosis of a previously implanted stent, with heavy calcifications in the arterial wall. The lesion was crossed with a non-mdt guidewire to the distal segment of the rca. Due to the unsuccessful attempts of pre-dilation with a non-mdt balloon the buddy wire technique was used. Then sequential inflations were done with three non-mdt semi-compliant balloons. The residual stenosis remained at around 70%¿80%. A high pressure non-mdt balloon was then inflated up to 40 atm with no success. Despite the use of the buddy wire technique and a non-mdt guide extension catheter, a non-mdt drug eluting stent (des) did not reach the distal segment of the artery. The patient was qualified for lithotripsy. Lithotripsy with a non-mdt device and a catheter balloon with 4¿6 atm was performed. This enabled the final optimization of stent expansion using a 4. 0 × 20 mm medtronic nc solarice balloon catheter with 22 atm. Dissection of the coronary artery wall behind the stent was found and required a non-mdt stent to be implanted. Stent optimization was performed using a 4. 0 × 20 mm nc solarice balloon catheter with 8-20 atm. Control ca and optical coherence tomography (oct) showed an acceptable effect of the pci within the rca. Please note that this device (nc solarice) is not marketed in the united states; however, the device is deemed the same as the united states marketed device (nc euphora).
 
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Brand NameNC SOLARICE RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key14141036
MDR Text Key289500662
Report Number9612164-2022-01500
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K141090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberNCSLC4020X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/19/2022 Patient Sequence Number: 1
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