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

Model Number 10623

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atherosclerosis (1728); Reocclusion (1985); Thrombosis (2100); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 08/10/2020

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that stent thrombosis occurred.In (b)(6) 2019, the subject was enrolled and the index procedure was performed on same day.The target lesion was located in the mid right coronary artery (rca) extending up to distal rca with 100% stenosis and was 93 mm long, with a reference vessel diameter of 4 mm.The target lesion was treated with pre-dilatation and placement of 4.00 mm x 24 mm synergy stent, overlapped with two 3.50 mm x 38 mm and 3.50 mm x 38 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease, stent thrombosis, and was hospitalized on the same day for further evaluation and treatment.On the following day, coronary angiography was performed which revealed 70% stenosis in mid rca.Balloon dilatation was performed to treat the event.The event was considered to be recovering/resolving and the subject was discharged on the next day.

Event Description

Synergy china registry.It was reported that stent thrombosis occurred.In (b)(6) 2019, the subject was enrolled and the index procedure was performed on same day.The target lesion was located in the mid right coronary artery (rca) extending up to distal rca with 100% stenosis and was 93 mm long, with a reference vessel diameter of 4 mm.The target lesion was treated with pre-dilatation and placement of 4.00 mm x 24 mm synergy stent, overlapped with two 3.50 mm x 38 mm and 3.50 mm x 38 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease, stent thrombosis, and was hospitalized on the same day for further evaluation and treatment.On the following day, coronary angiography was performed which revealed 70% thrombosis in mid rca.Balloon dilatation was performed to treat the event.The event was considered to be recovering/resolving and the subject was discharged on the next day.It was further reported that balloon dilatation was performed in the rca and left posterior descending artery which qualifies for target vessel revascularization (tvr) and non-tvr.

Event Description

Synergy china registry.It was reported that stent thrombosis occurred.In (b)(6) 2019, the subject was enrolled and the index procedure was performed on same day.The target lesion was located in the mid right coronary rtery (rca) extending up to distal rca with 100% stenosis and was 93 mm long, with a reference vessel diameter of 4 mm.The target lesion was treated with pre-dilatation and placement of 4.00 mm x 24 mm synergy stent, overlapped with two 3.50 mm x 38 mm and 3.50 mm x 38 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease, stent thrombosis, and was hospitalized on the same day for further evaluation and treatment.On the following day, coronary angiography was performed which revealed 70% thrombosis in mid rca.Balloon dilatation was performed to treat the event.The event was considered to be recovering/resolving and the subject was discharged on the next day.It was further reported that balloon dilatation was performed in the rca and left posterior descending artery which qualifies for target vessel revascularization (tvr) and non-tvr.It was further reported that the index procedure target lesion was located in the proximal rca extending to the distal rca.Additionally, in (b)(6) 2020, coronary angiography revealed 70% stenosis in proximal rca extending to mid rca was treated with percutaneous coronary intervention (pci).The event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was withdrawn.

Event Description

Synergy china registry.It was reported that stent thrombosis occurred.In (b)(6) 2019, the subject was enrolled and the index procedure was performed on same day.The target lesion was located in the mid right coronary rtery (rca) extending up to distal rca with 100% stenosis and was 93 mm long, with a reference vessel diameter of 4 mm.The target lesion was treated with pre-dilatation and placement of 4.00 mm x 24 mm synergy stent, overlapped with two 3.50 mm x 38 mm and 3.50 mm x 38 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease, stent thrombosis, and was hospitalized on the same day for further evaluation and treatment.On the following day, coronary angiography was performed which revealed 70% thrombosis in mid rca.Balloon dilatation was performed to treat the event.The event was considered to be recovering/resolving and the subject was discharged on the next day.It was further reported that balloon dilatation was performed in the rca and left posterior descending artery which qualifies for target vessel revascularization (tvr) and non-tvr.It was further reported that the index procedure target lesion was located in the proximal rca extending to the distal rca.Additionally, in (b)(6) 2020, coronary angiography revealed 70% stenosis in proximal rca extending to mid rca was treated with percutaneous coronary intervention (pci).The event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was withdrawn.It was further reported that at the time of the pci in (b)(6) 2020, the patient was asymptomatic with no signs of ischemia.

• 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: 10759081
• MDR Text Key: 213871459
• Report Number: 2134265-2020-14952
• 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,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0023148939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR