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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 10618
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Complaint, Ill-Defined (2331); Restenosis (4576); Insufficient Information (4580)
Event Date 07/06/2020
Event Type  Injury  
Event Description
Same case as pr id#: (b)(4). (b)(6) registry. It was reported that acute coronary syndrome occurred. In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization. Subsequently, index procedure was performed which revealed target lesion #1 was located in the mid left anterior descending (lad) artery extending to 1st diagonal with 95% stenosis and was 14 mm long and a reference vessel diameter of 2. 25 mm. Target lesion #1 was treated with pre-dilatation and placement of a 2. 25 mm x 16 mm and a 3mm x 16 mm synergy drug-eluting stent (des). Following this intervention, post dilation was performed with 0% residual stenosis. Target lesion #2 was located in the mid right coronary artery (rca) extending to proximal rca with 95% stenosis and was 20 mm long and a reference vessel diameter of 2. 75 mm. Target lesion #2 was treated with pre-dilatation and placement of a 3. 00 mm x 16 mm and a 2. 75 mm x 38 mm synergy des. Following this intervention, post dilation was performed with 0% residual stenosis. Four days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2020, 315 days post index procedure, the subject presented with symptoms of acute coronary syndrome and was hospitalized for further evaluation and treatment. No other action was taken to treat this event. Twenty-two days later, the event was considered recovered/resolved and the subject was discharged on aspirin and clopidogrel.
 
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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 Key10680071
MDR Text Key211446490
Report Number2134265-2020-13743
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,Followup,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/16/2020
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0023580979
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 Received10/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2019
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: 10/14/2020 Patient Sequence Number: 1
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