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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

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BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Restenosis (4576)
Event Date 07/12/2021
Event Type  Injury  
Event Description
Agent ide study. It was reported that angina and in-stent restenosis occurred. On (b)(6) 2020, a 3. 00 mm x 8 mm synergy stent was implanted in the proximal left circumflex artery (lcx) and a 3. 00 x 12mm synergy stent was implanted in the proximal rca. On (b)(6) 2020, severe in-stent restenosis (isr) was noted in the proximal rca. A 2. 75 x 28mm synergy stent and a 2. 75 x 12mm synergy stent were implanted in the proximal to mid rca to treat the restenosis. On (b)(6) 2021, the subject presented with stable angina and was randomized into the agent ide study and index procedure was performed the same day. Heparin or other antithrombotic medication were administered at the time of index procedure. The isr of the 3. 0 x 8mm synergy stent at the proximal lcx was treated with balloon angioplasty. On the same day, the 3. 00 x 10mm isr of the mid rca (where the 2. 75 x 28mm synergy and 2. 75 x 12mm synergy stents were located) was also treated. The target lesion was predilated with a 2. 5 mm x 15 mm balloon with 10% residual stenosis and timi flow 3. Following pre-dilation, the lesion was successfully treated with 3. 50 mm x 12 mm study device with 10% residual stenosis and timi flow 3. Post dilation was not performed. The subject experienced confusion, diarrhea, acute kidney injury, metabolic acidosis, and vertigo not considered related to the devices. On (b)(6) 2021, the subject was discharged on aspirin and clopidogrel.
 
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Brand NameSYNERGY
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13809114
MDR Text Key287408670
Report Number2134265-2022-02838
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/18/2022 Patient Sequence Number: 1
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