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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 10621
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Restenosis (4576)
Event Date 08/02/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone: (b)(6).
 
Event Description
Synergy (b)(6) registry. It was reported that unstable angina and restenosis occurred. In august 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 left anterior descending (lad) artery with 85% stenosis, was 24 mm 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 28 mm synergy stent system. Following this post dilation was performed with 0% residual stenosis. Two days later, the subject was discharged on aspirin and ticagrelor. In august 2021, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment. Three days later, the subject was referred for coronary angiography which revealed 80% stenosis in proximal lad artery which had previously placed study device was treated with percutaneous coronary intervention (pci) - target-vessel revascularization (tvr). Post intervention, residual stenosis was 0%. The rationale of intervention was angina and angiographic finding without symptoms or objective signs of ischemia. Two days later, the event was recovered and resolved, and the subject was discharged on the same day.
 
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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 Key12595067
MDR Text Key275504852
Report Number2134265-2021-12085
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 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/03/2022
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0025222822
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 Received09/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2020
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: 10/07/2021 Patient Sequence Number: 1
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