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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 Angina (1710); Restenosis (4576)
Event Date 07/14/2021
Event Type  Injury  
Event Description
Promus premier (b)(6) registry. It was reported that angina and restenosis occurred. In (b)(6) 2019, the subject was presented with myocardial infarction and was referred for cardiac catheterization. The index procedure was performed on the same day. Target lesion 1 was located in the proximal left anterior descending (lad) artery with 90% stenosis and was 34 mm long, with a reference vessel diameter of 3. 0 mm. Target lesion 1 was treated with pre-dilatation and placement of a 3. 00 mm x 38 mm promus premier stent system. Following this post dilatation was performed with residual stenosis as 10%. Two weeks later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and was hospitalized on the same day for further evaluation and treatment. On the following day, the subject was referred for coronary angiography which revealed 90% stenosis in mid lad which had previously placed study device was treated with drug-eluting coronary artery stenting target-vessel revascularization (tvr). Post intervention, residual stenosis was 10%. Three days later, the event was recovered and resolved and on the same day the subject was discharged on aspirin and clopidogrel.
 
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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 Key12475359
MDR Text Key271504591
Report Number2134265-2021-10960
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
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 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/26/2020
Device Model Number9554
Device Catalogue Number9554
Device Lot Number0022752536
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 Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2018
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: 09/15/2021 Patient Sequence Number: 1
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