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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Chest Tightness/Pressure (2463)
Event Date 01/11/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
(b)(6) clinical study. It was reported that patient experience chest tightness and nausea. In (b)(6) 2019, the patient presented for the index procedure. The target lesion was located in the proximal right coronary artery (rca) extending up to distal rca with 100% stenosis and was 96mm long, with a reference vessel diameter of 4mm. The lesion was treated with pre-dilatation and placement of 3. 00mmx38mm, 3. 5mmx38mm and 4. 00mmx28mm promus premier stents. Post dilatation was performed with 0% residual stenosis. On the same day, the patient was noted with chest tightness and nausea and was treated medically. The event was considered recovered/resolved that day. Nine days later, the patient was discharged.
 
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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 Key8322089
MDR Text Key135591277
Report Number2134265-2019-00931
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
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received01/21/2019
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: 02/08/2019 Patient Sequence Number: 1
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