MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 10619

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atherosclerosis (1728); Complaint, Ill-Defined (2331); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 11/18/2020

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that the subject experienced symptoms of coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The index procedure was performed and the target lesion was located in the mid left anterior descending artery (lad) with 90% stenosis and was 19 mm long, with a reference vessel diameter of 3 mm.The target lesion was treated with pre-dilatation and placement of a 3.0 x 20 mm synergy china stent system.Following post-dilatation, the residual stenosis was 0%.Myocardial enzyme elevation was also confirmed.Two days later, the subject was discharged on aspirin and other antiplatelet medications.In (b)(6) 2020, the subject presented with symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Subject was diagnosed with coronary atherosclerotic heart disease and coronary angiography was recommended.At the time of reporting, the event was considered recovering/resolving.Two days later, the subject was discharged on aspirin and other antiplatelet medications.No other information is available at this point of time.

Event Description

Synergy china registry.It was reported that the subject experienced symptoms of coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The index procedure was performed and the target lesion was located in the mid left anterior descending artery (lad) with 90% stenosis and was 19 mm long, with a reference vessel diameter of 3 mm.The target lesion was treated with pre-dilatation and placement of a 3.0 x 20 mm synergy china stent system.Following post-dilatation, the residual stenosis was 0%.Myocardial enzyme elevation was also confirmed.Two days later, the subject was discharged on aspirin and other antiplatelet medications.In (b)(6) 2020, the subject presented with symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Subject was diagnosed with coronary atherosclerotic heart disease and coronary angiography was recommended.At the time of reporting, the event was considered recovering/resolving.Two days later, the subject was discharged on aspirin and other antiplatelet medications.No other information is available at this point of time.It was further reported that coronary angiography without revascularization was performed in (b)(6) 2020.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11023073
• MDR Text Key: 221868620
• Report Number: 2134265-2020-18021
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0023299302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 67 YR