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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 9554
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Arteriosclerosis/ Atherosclerosis (4437)
Event Date 04/01/2021
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that coronary artery bypass grafting was performed. In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed. Target lesion 1 was located in the proximal right coronary artery (rca) extending into mid rca with 100% stenosis and was 70mm long with a reference vessel diameter of 3. 5 mm. Target lesion was treated with pre-dilatation and placement of 3. 5 mm x 38 mm promus premier stent system stent. Post-dilatation was performed with 0% residual stenosis. On the following day, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2021, post index procedure, the subject was diagnosed with unknown type of coronary artery disease. The subject was hospitalized on the same day. The event was treated with coronary artery bypass grafting. At the time of reporting, the outcome of the event was unknown.
 
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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 Key11936807
MDR Text Key254298186
Report Number2134265-2021-06827
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,Followup
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/18/2020
Device Model Number9554
Device Catalogue Number9554
Device Lot Number0022855947
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 Received07/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2018
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: 06/04/2021 Patient Sequence Number: 1
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