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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9551
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arteriosclerosis/ Atherosclerosis (4437)
Event Date 04/28/2019
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that coronary atherosclerotic cardiopathy occurred. In (b)(6) 2019, the subject was presented with an unstable angina and was referred for cardiac catheterization. On the same day the index procedure was performed. The target lesion was located in the distal left circumflex artery (lcx) with 100% stenosis and was 23mm long, with a reference vessel diameter of 2. 75mm. The target lesion was treated with pre-dilatation and placement of a 2. 75mm x 24mm promus premier stent system. Following post dilation, the residual stenosis was 0%. Two days later, the subject was discharged on aspirin and ticagrelor. In (b)(6) 2019, thirteen days post index procedure, the subject presented with symptoms of coronary atherosclerotic cardiopathy and was hospitalized on the same day for further evaluation and treatment. Coronary atherosclerotic cardiopathy was diagnosed and no other actions were taken with regards to this event. Four days later, the event was considered recovering and resolving and subject was discharged on the same day.
 
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Brand NamePROMUS PREMIER
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 Key11817028
MDR Text Key250361876
Report Number2134265-2021-06266
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 05/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/21/2019
Device Model Number9551
Device Catalogue Number9551
Device Lot Number0021439014
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 Received04/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2017
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: 05/13/2021 Patient Sequence Number: 1
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