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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number SPL40020X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Embolism/Embolus (4438)
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An article was submitted. The aim of this study was to determine the long-term patency rates of middle/distal common carotid artery (cca) stenting and to investigate predisposing factors in the development of in-stent restenosis (isr) fifty-one patients who underwent stenting with 51 self-expandable stents for significant stenosis of the middle and/or distal cca between 2000 and 2018 were analyzed retrospectively. The median follow-up time was 35 months. Pre-dilation was carried out in only two cases. In one of these cases, a sprinter legend rx balloon was used for pre-dilation purposes. Technical success was achieved in all patients. Two neurological complications were observed to have developed: one contralateral hemiparesis plus aphasia that lasted for 5 min after balloon inflation, and one transient contralateral upper extremity numbness. A non-medtronic cerebral protection device was utilized in both these patients, with debris (embolic material) found in the filter of the latter complication. All neurological symptoms disappeared spontaneously. Computed tomography examination performed within 2 h of the onset of symptoms revealed no evidence of acute brain ischemia or intracranial arterial obstruction in either patient. The 30-day all-cause mortality rate was zero.
 
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Brand NameSPRINTER LEGEND RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10835292
MDR Text Key216093795
Report Number9612164-2020-04410
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeHU
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSPL40020X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
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: 11/13/2020 Patient Sequence Number: 1
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