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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
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of sprinter legend. Survey results from an interventional radiologist in practice 11 years. The physician has used 110 sprinter legend rx (4. 00 x 30 mm) balloons in the past 12 months adverse events/effects that were encountered in the using sprinter legend over the last 12 months included death ,coronary vessel dissection, perforation, rupture, or injury, arrhythmias, including ventricular fibrillation, total occlusion of the coronary artery or bypass graft (as a result of ptca procedure),restenosis of the dilated vessel (within procedure or after procedure),coronary artery spasm and drug reactions or allergic reaction to contrast medium. It was reported that the death ,coronary vessel dissection, perforation, rupture, or injury, arrhythmias, including ventricular fibrillation events were related to the procedure but not directly to sprinter legend rx it was reported that the total occlusion of the coronary artery or bypass graft (as a result of ptca procedure), restenosis of the dilated vessel (within procedure or after procedure), coronary artery spasm and drug reactions or allergic reaction to contrast medium were related to a pre-existing condition or comorbidity.
 
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Brand NameSPRINTER LEGEND RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
mexico
Manufacturer (Section G)
MEDTRONIC MEXICO
mexico
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9295832
MDR Text Key165595085
Report Number9612164-2019-04699
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2019
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

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