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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
Model Number 10603
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Myocardial Infarction (1969); Thrombosis (2100); Complaint, Ill-Defined (2331)
Event Date 09/14/2020
Event Type  Injury  
Event Description
It was reported that myocardial infarction, right ventricular failure and acute stent thrombosis occurred. In (b)(6) 2020, the patient was admitted with spinal stenosis and underwent surgery. The target lesions were located in the left anterior descending (lad) with 70% stenosis, circumflex (cx) with 90% stenosis, and right coronary arteries (rca) with 95% stenosis. A 2. 75x20mm and 3. 0x16mm synergy drug-eluting stents were implanted in the rca. After the surgery, the patient was taken to the post-anesthesia care unit (pacu); however, the patient suffered from myocardial infarction. On the following day, the patient was taken back to the cardiac catherization lab and found to have an acute stent thrombosis in both synergy stents in the rca that was implanted 1 day prior. Balloon angioplasty was performed and stented with non-boston scientific stents. The patient experienced right ventricular failure and received impella and extracorporeal membrane oxygenation (ecmo) and was still admitted.
 
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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 CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10727376
MDR Text Key212752042
Report Number2134265-2020-14308
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/29/2021
Device Model Number10603
Device Catalogue Number10603
Device Lot Number0024590898
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 Received10/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2019
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: 10/23/2020 Patient Sequence Number: 1
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