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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10623
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arteriosclerosis/ Atherosclerosis (4437)
Event Date 08/04/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
(b)(6) registry. It was reported that coronary atherosclerotic heart disease occurred. In (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day. The target lesion 1 was located in the proximal right coronary artery (rca) extending up to distal rca with 90% stenosis was 51mm long and a reference vessel diameter of 2. 75 mm. The target lesion 1 was treated with pre-dilation and placement of 2. 75 mm x 38 mm synergy stent system. Following this post dilation was performed with 0% residual stenosis. It was also noted that an additional drug-eluting stent was also used, however, details were not available. On the next day, the subject was discharged. In (b)(6) 2021, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment. Angiography without revascularization was performed. On the next day, the subject was discharged and the event was considered as recovering and resolving.
 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
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 Key12619734
MDR Text Key276138825
Report Number2134265-2021-12287
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 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/02/2020
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0023944397
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 Received09/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2019
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: 10/12/2021 Patient Sequence Number: 1
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