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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 10622
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Ischemia (1942); Restenosis (4576)
Event Date 11/12/2021
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that unstable angina and restenosis occurred. In (b)(6) 2020, the subject with unstable angina was referred for cardiac catheterization. The index procedure was performed on the same day. The target lesion 1 was located in the proximal left anterior descending (lad) artery to mid lad with 85% stenosis and was 32 mm long, with a reference vessel diameter of 3. 5 mm. The target lesion 1 was treated with pre-dilatation and placement of 3. 50 mm x 32 mm synergy stent system. Following post-dilatation the residual stenosis was noted to be 0%. Two days later, the subject was discharged on aspirin and ticagrelor. In (b)(6) 2021, the subject with symptoms of ischemia and angina was hospitalized for further evaluation and treatment. Coronary angiography which revealed 85% stenosis noted in proximal extending up to mid lad which had previously placed study device was treated with percutaneous coronary intervention. Post intervention, residual stenosis was 0% target-vessel revascularization (tvr). The rationale for intervention was angina, symptoms of ischemia and angiographic finding without symptoms or objective signs of ischemia. On the following day, the outcome of the event was considered to be recovering and resolving. The subject was discharged on aspirin and ticagrelor.
 
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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 Key13358205
MDR Text Key284455612
Report Number2134265-2022-00677
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
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/17/2020
Device Model Number10622
Device Catalogue Number10622
Device Lot Number0023854186
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2019
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: 01/26/2022 Patient Sequence Number: 1
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