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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 Atrial Fibrillation (1729)
Event Date 04/18/2019
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that paroxysmal atrial fibrillation occurred. In (b)(6) 2019, the subject presented with unstable angina and was 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 80% stenosis and was 20mm long and a reference vessel diameter of 3. 5mm. The target lesion was treated with pre-dilatation and placement of a 3. 50mm x 24mm promus premier study stent. Post-dilatation was performed with 0% residual stenosis. On the following day, the subject was discharged on aspirin and clopidogrel. Two weeks and two days later, the subject was diagnosed with paroxysmal atrial fibrillation and was hospitalized on the same day for further evaluation and treatment. Radiofrequency ablation was performed to treat the event. Nine days later, the outcome of the event was considered resolved and the subject was discharged on clopidogrel and aspirin 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 Key11813590
MDR Text Key250247652
Report Number2134265-2021-06212
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 Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/26/2020
Device Model Number9551
Device Catalogue Number9551
Device Lot Number0022597817
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 Manufactured08/27/2018
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: 05/12/2021 Patient Sequence Number: 1
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