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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV SPRINTER® LEGEND CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC MEXICO S. DE R.L. DE CV SPRINTER® LEGEND CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number SPL25015X
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2019
Event Type  malfunction  
Event Description
An elderly male patient presents with a history significant for type 1 diabetes, hypertension, hyperlipidemia, coronary artery disease status post coronary artery bypass grafting (cabg), gastroesophageal reflux disease (gerd), and acute respiratory failure. While performing a heart catheterization, synergy stent deployed angiograms done. Stent appeared to have fracture. Intravascular ultrasound (ivus) procedure done to verify. Second stent deployed over fractured stent.
 
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Brand NameSPRINTER® LEGEND
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO S. DE R.L. DE CV
8200 coral sea st ne # mvs74
moundsview MN 55112
MDR Report Key9488668
MDR Text Key171826636
Report Number9488668
Device Sequence Number1
Product Code LOX
UDI-Device Identifier00613994902597
UDI-Public(01)00613994902597(17)220924(10)218568887
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPL25015X
Device Lot Number218568887
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/05/2019
Event Location Hospital
Date Report to Manufacturer12/18/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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