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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 Problem Complaint, Ill-Defined (2331)
Event Date 08/05/2020
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that the subject experienced symptoms related coronary atherosclerotic heart disease and was hospitalized. In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization, the index procedure was performed on the same day. The target lesion was located in the mid left circumflex (lcx) extending up to distal lcx with 100% stenosis and was 59 mm long, with a reference vessel diameter of 2. 75 mm. The target lesion was treated with pre-dilatation and with placement of a 2. 50 mm x 32mm and a 2. 75mm x 32 mm synergy drug-eluting stent system. Following post-dilatation, the residual stenosis was 0%. The following day the patient was discharged. In (b)(6) 2020, unknown number of days post index procedure, the subject presented with symptoms related to coronary atherosclerotic heart disease and was hospitalized for further evaluation and treatment. The subject was diagnosed with coronary atherosclerotic heart disease and balloon dilation was performed to treat the event. The subject was discharged and the event was considered to be recovering/resolving. The lesion location of the balloon dilation treatment is unknown and the physician assessed it as unlikely related to the study device. In (b)(6) 2020, 335 days post index procedure, the subject presented with [unknown] symptoms related to coronary atherosclerotic heart disease and on the same day was hospitalized for further evaluation and treatment. The patient was diagnosed with coronary atherosclerotic heart disease and angiography without revascularization was performed during the event. No other action was taken, however, the physician assessment that the event was related to the study device was reported as possible. Two days later, the subject was discharged and the event was considered to be recovering/resolving.
 
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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 Key10683346
MDR Text Key211459647
Report Number2134265-2020-13882
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 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/13/2019
Device Model Number10622
Device Catalogue Number10622
Device Lot Number0022194140
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 Received09/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2018
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: 10/15/2020 Patient Sequence Number: 1
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