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

Model Number 10623

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

Patient Problems Atherosclerosis (1728); Thrombosis (2100); Complaint, Ill-Defined (2331)

Event Date 08/29/2020

Event Type  Injury  

Event Description

(b)(6) clinical study.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 80% stenosis and was 51 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.An additional drug eluting stent was implanted to cover the lesion length.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with unknown symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.Angiography without revascularization was performed during the event and at the time of reporting, the event was considered recovering/resolving.Four days later, the subject was discharged on aspirin and clopidogrel.

Event Description

Synergy china registry clinical study.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 80% stenosis and was 51 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.An additional drug eluting stent was implanted to cover the lesion length.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with unknown symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.Angiography without revascularization was performed during the event and at the time of reporting, the event was considered recovering/resolving.Four days later, the subject was discharged on aspirin and clopidogrel.It was further reported that in (b)(6) 2020, angiography was performed which revealed 20% stenosis in the proximal lad which is lesion treated during index procedure and the subject was diagnosed with stent thrombosis.

Event Description

Synergy china registry clinical study it was reported that coronary atherosclerotic heart disease and stent thrombosis occurred.In october 2019, the index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 80% stenosis and was 51 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.An additional drug eluting stent was implanted to cover the lesion length.The following day, the subject was discharged on aspirin and clopidogrel.In august 2020, the subject presented with unknown symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.Angiography without revascularization was performed during the event and at the time of reporting, the event was considered recovering/resolving.Four days later, the subject was discharged on aspirin and clopidogrel.It was further reported that in august 2020, angiography was performed which revealed 20% stenosis in the proximal lad which is lesion treated during index procedure and the subject was diagnosed with stent thrombosis.It was further reported that the event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was removed.

• 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: 10819338
• MDR Text Key: 215610201
• Report Number: 2134265-2020-15635
• 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,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0023242482
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 YR