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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 Problem Discomfort (2330)
Event Date 10/18/2018
Event Type  Injury  
Manufacturer Narrative

Device is combination product.

 
Event Description

(b)(6) clinical study. It was reported that patient experienced discomfort in the precordial area. In (b)(6) 2018, the subject was referred for cardiac catheterization and the index procedure was performed was performed on the same day. The target lesion was located in the mid right coronary artery (rca) extending up to distal rca with 95% stenosis and was 37 mm long, with a reference vessel diameter of 3. 0 mm. The lesion was treated with pre-dilatation and placement of a 3. 0 mm x 38 mm promus premier stent with 0% residual stenosis. Post dilatation was not performed. Ten days post procedure, the subject was noted with discomfort of the precordial area considered probably related to the device. Hemianopsia of right field of vision and angina attack also occurred. The precordial discomfort and hemianopsia were treated with medications. No action was taken to treat the angina attack. The next day the discomfort and hemianopsia were considered resolved.

 
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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 IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8086438
MDR Text Key127802619
Report Number2134265-2018-62877
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 04/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/18/2020
Device MODEL Number9554
Device Catalogue Number9554
Device LOT Number0022047098
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 Received03/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/19/2018 Patient Sequence Number: 1
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