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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 Complaint, Ill-Defined (2331)
Event Date 09/10/2020
Event Type  Injury  
Event Description
(b)(6). It was reported that the subject experienced symptoms of coronary atherosclerotic heart disease. In (b)(6) 2019, the index procedure was performed. The target lesion was located in the proximal right coronary artery (rca) extended to mid rca with 100% stenosis and was 30 mm long, with a reference vessel diameter of 3. 4 mm. The target lesion was treated with pre-dilatation and placement of a 3. 50 x 38 mm synergy stent system. Following post-dilatation, the residual stenosis was 0%. Nine days later, the subject was discharged on aspirin and other antiplatelet medications. In (b)(6) 2020, 322 days post index procedure, the subject presented with symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment. The subject was diagnosed with coronary atherosclerotic heart disease and event was treated medically. Two days later, the event was considered recovering/resolving and the subject was discharged on aspirin and other antiplatelet medications.
 
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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 Key10779589
MDR Text Key214380586
Report Number2134265-2020-15048
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
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/15/2020
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0023583312
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 Received10/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2019
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: 11/03/2020 Patient Sequence Number: 1
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