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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 10620
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Angina (1710)
Event Date 12/05/2020
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that unstable angina occurred. In (b)(6) 2019, the subject was referred to cardiac catheterization and the index procedure was performed on the same day. The target lesion 1 was located in the distal left circumflex (lcx) artery with 90% stenosis and was 24 mm long and a reference vessel diameter of 2. 25 mm. The target lesion was treated with pre-dilatation and placement of a 2. 25 mm x 28 mm synergy study stent. Following this post dilation was performed with 0% residual stenosis. The target lesion 2 was located in the mid left anterior descending (lad) artery with 90% stenosis and was 38 mm long and a reference vessel diameter of 2. 50 mm. The target lesion was treated with pre-dilatation and placement of a 2. 25 mm x 38 mm overlapped with 2. 75 mm x 24 mm synergy study stents. Following this post dilation was performed with 0% residual stenosis. Three days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2020, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment. Three days later, coronary angiography revealed 50% stenosis in distal lcx and it was treated with percutaneous coronary intervention (pci) - target-vessel revascularization (tvr). Post intervention, residual stenosis was 0%. The rationale for tvr was angina. At the time of reporting the event was not recovered and not resolved. Six days after hospitalization, the subject was discharged.
 
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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 Key12617727
MDR Text Key275985234
Report Number2134265-2021-12554
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,Followup
Report Date 07/06/2022
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 Date10/05/2020
Device Model Number10620
Device Catalogue Number10620
Device Lot Number0023654866
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2019
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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