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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9305
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arteriosclerosis/ Atherosclerosis (4437)
Event Date 05/11/2015
Event Type  Injury  
Event Description
(b)(6) clinical study. It was reported that coronary atherosclerotic cardiopathy occurred. In (b)(6) 2014, the subject presented with unstable angina as well as silent ischemia and referred for cardiac catheterization. The index procedure was performed on the same day. The target lesion was located in the proximal left anterior descending artery (lad) with 90% stenosis and was 12mm long, with a reference vessel diameter of 3. 0mm. The target lesion was treated with pre-dilatation and placement of 3. 00mmx16mm promus element stent. Following this post-dilatation was performed with 0% residual stenosis. A week later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2015, post index procedure, the subject was diagnosed with coronary atherosclerotic cardiopathy and hospitalized on the same day for further evaluation and treatment. Medication was given to treat the event. Eight days later, the event was recovered/resolved and the subject was discharged on the same day.
 
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Brand NamePROMUS ELEMENT
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11751134
MDR Text Key248172532
Report Number2134265-2021-05493
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
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 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/13/2015
Device Model Number9305
Device Catalogue Number9305
Device Lot Number0016543022
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 Received04/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2013
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: 04/30/2021 Patient Sequence Number: 1
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