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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); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891)
Event Date 07/01/2021
Event Type  Injury  
Manufacturer Narrative
Journal article: a single-center experience of endovascular treatment in subtypes of basilar artery occlusion: embolization caused by tandem vertebral artery stenosis may be associated with better outcomes authors: lin jiang, jian-hong yang, jie ruan journal: world neurosurgery year: 2021. Reference: doi. Org/10. 1016/j. Wneu. 2021. 05. 011. Patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the death(s). Was provided average age, majority gender, date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
An article titled - a single-center experience of endovascular treatment in subtypes of basilar artery occlusion: embolization caused by tandem vertebral artery stenosis may be associated with better outcomes - was submitted. The aim of the study was to compare the surgical procedures and clinical outcomes of mechanical thrombectomy in different subtypes of basilar artery occlusion (bao). Eighty-six patients with acute bao receiving endovascular treatment between october 2015 and july 2019 were retrospectively analyzed and placed in 3 groups: pure embolism (group 1), arterial-arterial embolism from steno-occlusion of the tandem vertebral artery (group 2), and in situ atherosclerotic thrombosis (group 3). Recanalization rates, procedure times, surgical characteristics, and clinical outcomes were analyzed. Rescue treatment was performed by switching to the stent retriever or aspiration, balloon angioplasty, permanent stent placement, intra-arterial glycoprotein iib/iiia antagonist, or any combination of these. Three patients had a balloon angioplasty. Balloon angioplasty was carried out with either a medtronic sprinter legend balloon or a n on-medtronic balloon. Clinical outcomes among the three basilar artery occlusion subtypes included intra-arterial tirofiban, modified thrombolysis in cerebral infarction (mtici) grade 2b or 3, mortality at 90 days, any hemorrhagic complication, symptomatic intracerebral hemorrhage and parenchymal hemorrhage type 2.
 
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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 Key12959440
MDR Text Key285344759
Report Number9612164-2021-04758
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 12/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
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
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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