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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 Problems Death (1802); Thrombosis (2100); Complaint, Ill-Defined (2331)
Event Date 12/08/2020
Event Type  Death  
Event Description
It was reported that acute thrombosis occurred and the patient died. The de novo target lesion was located in the calcified left anterior descending artery. Following pre-dilatation of a 2. 5x15mm maverick balloon catheter, a 24 x 2. 50 promus premier drug-eluting stent was advanced for treatment. However, an acute stent thrombosis was noted upon electrocardiogram. The patient develop problem at night and died due to cardiac arrest.
 
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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 Key11021492
MDR Text Key221825274
Report Number2134265-2020-17900
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeBG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/11/2021
Device Model Number9551
Device Catalogue Number9551
Device Lot Number0024807287
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 Received01/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2019
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: 12/16/2020 Patient Sequence Number: 1
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