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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 Syncope (1610); No Code Available (3191)
Event Date 10/05/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter facility name: the 2nd affiliated hospital of (b)(6). Device is a combination product.
 
Event Description
(b)(6) clinical study. It was reported that patient experienced syncope. In (b)(6) 2018, the subject was referred for cardiac catheterization and index procedure was performed on the same day. The target lesion was located in the mid right coronary artery (rca) extending up to distal rca with 100% stenosis and was 68 mm long, with a reference vessel diameter of 3. 0 mm. The lesion was treated with pre-dilatation and placement of two study stents (2. 50 mm x 38 mm and 3. 00 mm x 38 mm). Following post-dilatation, the residual stenosis was 0%. Three days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2019, 381 days post index procedure, the subject was diagnosed with syncope and was hospitalized for further evaluation on the same day. The subject was diagnosed with an imaging procedure and a stent was implanted in the middle and proximal right coronary arteries. The event was considered resolved with residual effects and the subject was discharged home 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 Key9304583
MDR Text Key166048419
Report Number2134265-2019-13641
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,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9554
Device Catalogue Number9554
Device Lot Number0021747540
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 Received09/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2018
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: 11/11/2019 Patient Sequence Number: 1
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