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

Model Number 10618

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

Patient Problems Complaint, Ill-Defined (2331); Restenosis (4576); Insufficient Information (4580)

Event Date 07/06/2020

Event Type  Injury  

Event Description

Same case as pr id#: (b)(4).(b)(6) registry.It was reported that acute coronary syndrome occurred.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed which revealed target lesion #1 was located in the mid left anterior descending (lad) artery extending to 1st diagonal with 95% stenosis and was 14 mm long and a reference vessel diameter of 2.25 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.25 mm x 16 mm and a 3mm x 16 mm synergy drug-eluting stent (des).Following this intervention, post dilation was performed with 0% residual stenosis.Target lesion #2 was located in the mid right coronary artery (rca) extending to proximal rca with 95% stenosis and was 20 mm long and a reference vessel diameter of 2.75 mm.Target lesion #2 was treated with pre-dilatation and placement of a 3.00 mm x 16 mm and a 2.75 mm x 38 mm synergy des.Following this intervention, post dilation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, 315 days post index procedure, the subject presented with symptoms of acute coronary syndrome and was hospitalized for further evaluation and treatment.No other action was taken to treat this event.Twenty-two days later, the event was considered recovered/resolved and the subject was discharged on aspirin and clopidogrel.

Event Description

Same case as pr id# (b)(4).Synergy china registry.It was reported that acute coronary syndrome occurred.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed which revealed target lesion #1 was located in the mid left anterior descending (lad) artery extending to 1st diagonal with 95% stenosis and was 14 mm long and a reference vessel diameter of 2.25 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.25 mm x 16 mm and a 3mm x 16 mm synergy drug-eluting stent (des).Following this intervention, post dilation was performed with 0% residual stenosis.Target lesion #2 was located in the mid right coronary artery (rca) extending to proximal rca with 95% stenosis and was 20 mm long and a reference vessel diameter of 2.75 mm.Target lesion #2 was treated with pre-dilatation and placement of a 3.00 mm x 16 mm and a 2.75 mm x 38 mm synergy des.Following this intervention, post dilation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, 315 days post index procedure, the subject presented with symptoms of acute coronary syndrome and was hospitalized for further evaluation and treatment.No other action was taken to treat this event.Twenty-two days later, the event was considered recovered/resolved and the subject was discharged on aspirin and clopidogrel.It was further reported that the target lesion #1 was located in proximal lad to mid lad with 99% stenosis.The stent used was a 2.75 mmx16 mm synergy stent system instead of 3 mmx16 mm as previously reported.In (b)(6) 2020, the subject was diagnosed with acute coronary syndrome and angiography revealed 80% stenosis in proximal to mid lad.The rationale for target vessel revascularization (tvr) were electrocardiogram (ecg) changes and angiographic finding without symptoms or objective signs of ischemia.In (b)(6) 2020, 70% stenosis noted in proximal lad extending up to mid lad was treated with percutaneous coronary intervention.Post intervention, residual stenosis was 0% tvr.The physician considers the event not related to the study device.

Event Description

Same case as pr id# (b)(4), (b)(6) it was reported that acute coronary syndrome occurred.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed which revealed target lesion #1 was located in the mid left anterior descending (lad) artery extending to 1st diagonal with 95% stenosis and was 14 mm long and a reference vessel diameter of 2.25 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.25 mm x 16 mm and a 3mm x 16 mm synergy drug-eluting stent (des).Following this intervention, post dilation was performed with 0% residual stenosis.Target lesion #2 was located in the mid right coronary artery (rca) extending to proximal rca with 95% stenosis and was 20 mm long and a reference vessel diameter of 2.75 mm.Target lesion #2 was treated with pre-dilatation and placement of a 3.00 mm x 16 mm and a 2.75 mm x 38 mm synergy des.Following this intervention, post dilation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, 315 days post index procedure, the subject presented with symptoms of acute coronary syndrome and was hospitalized for further evaluation and treatment.No other action was taken to treat this event.Twenty-two days later, the event was considered recovered/resolved and the subject was discharged on aspirin and clopidogrel.It was further reported that the target lesion #1 was located in proximal lad to mid lad with 99% stenosis.The stent used was a 2.75 mmx16 mm synergy stent system instead of 3 mmx16 mm as previously reported.In july 2020, the subject was diagnosed with acute coronary syndrome and angiography revealed 80% stenosis in proximal to mid lad.The rationale for tcr were ecg changes and angiographic finding without symptoms or objective signs of ischemia.In (b)(6) 2020, 70% stenosis noted in proximal lad extending up to mid lad was treated with percutaneous coronary intervention.Post intervention, residual stenosis was 0% target-vessel revascularization (tvr).The physician considers the event not related to the study device.It was further reported that the target lesion 1 was 27mm long instead of 14mm and the target lesion 2 was 47mm long instead of 20mm as previously reported.The physician considers the acs event in (b)(6) 2020 as possibly related to the study device.

• 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: 10680071
• MDR Text Key: 211446490
• Report Number: 2134265-2020-13743
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2020
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0023580979
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 62 YR