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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 9550
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Event Date 08/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: used (b)(6) 2021 as the exact event date was unknown.
 
Event Description
Promus premier china registry. It was reported that coronary atherosclerotic heart disease and target vessel revascularization occurred. In late (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed. The target lesion 1 was in the distal left circumflex (lcx) artery with 95% stenosis and was 18 mm long, with a reference vessel diameter of 3. 5 mm. The target lesion 1 was treated with pre-dilatation and placement of a 3. 50 mm x 20 mm promus premier stent system. Post-dilation was performed, and the residual stenosis was 0%. Three days later, in (b)(6) 2019, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2021, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on same day for further evaluation. Target-vessel revascularization (tvr) was performed as corrective action. The event was considered to be resolved and the subject 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 CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13946408
MDR Text Key288171729
Report Number2134265-2022-03337
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 Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/16/2020
Device Model Number9550
Device Catalogue Number9550
Device Lot Number0022427414
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2018
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: 03/30/2022 Patient Sequence Number: 1
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