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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 Myocardial Infarction (1969); Reocclusion (1985); Complaint, Ill-Defined (2331); Restenosis (4576)
Event Date 09/02/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.
 
Event Description
(b)(6) registry it was reported that acute coronary syndrome occurred. In (b)(6) 2019, 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) with 90% stenosis and was 34mm long and a reference vessel diameter of 2. 75mm. The lesion was treated with pre-dilatation and placement of a 2. 75mmx38mm promus premier drug-eluting stent. Following post dilatation was performed with 10% residual stenosis. Five days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2019, the subject presented with symptoms related to acute coronary syndrome (acs) and was hospitalized for further evaluation and treatment. The subject was diagnosed with acs and no other action was taken to treat the event. Two weeks later, the event was considered recovered/resolved and on the same day, the subject was discharged on aspirin and clopidogrel. No other information is available at this point of time.
 
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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 Key10858633
MDR Text Key216842017
Report Number2134265-2020-15989
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,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/04/2020
Device Model Number9554
Device Catalogue Number9554
Device Lot Number0022645355
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 Received03/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2018
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: 11/18/2020 Patient Sequence Number: 1
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