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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 9553
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Ischemia (1942)
Event Date 12/26/2021
Event Type  Death  
Event Description
It was reported that the patient died. The patient presented with extensive anterior myocardial infarction. The fully occluded de novo target lesion was located in the moderately calcified proximal left anterior descending artery. After pre-dilation with a 10 x 2. 00 non-boston scientific balloon, a 32 x 2. 75 promus premier drug eluting stent was successfully deployed. Post deployment, slow flow was observed and the patient went into cardiac arrest. Cardiopulmonary resuscitation was performed on the table and the patient was transferred to the cardiac care unit in stable condition. The patient subsequently died that 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 Key13192706
MDR Text Key283411289
Report Number2134265-2022-00062
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeBG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9553
Device Catalogue Number9553
Device Lot Number0027577488
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2021
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: 01/07/2022 Patient Sequence Number: 1
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