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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT PLUS STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT PLUS STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9394
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sudden Cardiac Death (2510)
Event Date 10/23/2018
Event Type  Death  
Manufacturer Narrative
Device is a combination product.
 
Event Description
(b)(6) clinical study. It was reported that the patient died. In (b)(6) 2014, the patient was presented with unstable angina and was referred for cardiac catheterization. Index procedure was performed on the same day. The target lesion was located in the mid left anterior descending artery with 100% stenosis and was 33 mm long, with a reference vessel diameter of 3. 5 mm. The target lesion was treated with pre-dilation and placement of 3. 50 x 38 mm promus element stent with 0% residual stenosis. Eight days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2018, 1574 days post index procedure, the patient suddenly died.
 
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Brand NamePROMUS ELEMENT PLUS
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8870770
MDR Text Key153573659
Report Number2134265-2019-08792
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
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 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/09/2015
Device Model Number9394
Device Catalogue Number9394
Device Lot Number0016395709
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 Received07/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2013
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: 08/07/2019 Patient Sequence Number: 1
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