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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR SPRINT RX; STENT, CORONARY, DRUG-ELUTING
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MEDTRONIC IRELAND ENDEAVOR SPRINT RX; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiomyopathy (1764); Death (1802)
Event Date 09/05/2013
Event Type  Death  
Event Description
During index procedure the patient had one endeavor sprint drug-eluting stent implanted to the lad.Approximately 25.5 months post index procedure patient death occurred.Cause of death cardiac (vascular fibrillation, cardiomyopathy).Investigator indicated that the reported death was not related to the study device or procedure.
 
Manufacturer Narrative
(b)(4).Results: (death).
 
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Brand Name
ENDEAVOR SPRINT RX
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key3755271
MDR Text Key4468518
Report Number9612164-2014-00422
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P060033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2014
Initial Date FDA Received04/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ASA
Patient Outcome(s) Death;
Patient Age00053 YR
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