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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,

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MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Obstruction/Occlusion (2422); Embolism/Embolus (4438)
Event Date 07/01/2021
Event Type  Injury  
Manufacturer Narrative
Journal article: dislodged clot during percutaneous coronary intervention: from the heart to the brain authors: jose danilo b. Diestro, rahul bhindi, johnston t. Te jr. , carmen parra-farinas, michael j. Kutryk, thomas r. Marotta journal: the canadian journal of neurological sciences year: 2021 reference: doi:10. 1017/cjn. 2020. 212. Date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article titled - dislodged clot during percutaneous coronary intervention: from the heart to the brain - was submitted for review. This case study describes a patient who was diagnosed with non-st elevation myocardial infarction (nstemi) after presenting to hospital with a three day history of progressive dyspnea. Six days after symptom onset the patient underwent percutaneous coronary intervention (pci). The left circumflex artery, with a 70% mid-vessel stenosis, was stented. The right coronary artery (rca) was totally occluded proximally by a thrombus. After a second balloon dilation with a 2. 0 x 20mm medtronic sprinter legend balloon, the thrombus disappeared. After stent placement in the rca, the patient became agitated and confused, attributed to periprocedural sedation. In recovery the patient become dysarthric and consequently a code stroke was called. The initial plain cranial ct showed an alberta stroke program early ct score (aspects) of 6 and an occlusion at the left m1¿m2 junction. The patient underwent successful (tici 3) thrombectomy with a combined 4 x 40 mm medtronic solitaire stent retriever and a non-medtronic aspiration device. Three months later, the patient only had moderate expressive aphasia. It was stated that the radiographic documentation and temporal progression of symptoms in this case support an intraprocedural embolization from the rca to the left middle cerebral artery as a very rare mechanism causing the stroke.
 
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Brand NameSPRINTER LEGEND 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12679469
MDR Text Key277883061
Report Number9612164-2021-04051
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received10/15/2021
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: 10/22/2021 Patient Sequence Number: 1
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