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

Model Number 10621

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

Patient Problems Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 05/05/2020

Event Type  Injury  

Event Description

(b)(6) registry it was reported that coronary atherosclerotic heart disease and restenosis occurred.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion 1 was located in the proximal left anterior descending artery (lad) extending up to mid lad with 70 % stenosis and was 47 mm long, with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of 2.50mmx 28 mm stent overlapped with another 2.75 mm x 24 mm synergy stent system.Post-dilatation was performed with 0% residual stenosis.The target lesion 2 was located in the mid left circumflex artery (lcx) with 90% stenosis and was 25mm long, with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 28 mm synergy stent system.Post-dilatation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin, clopidogrel and ticagrelor.In (b)(6) 2020, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.On the following day, the subject was referred for coronary angiography which revealed 85% proximal stenosis in lcx extending up to distal lcx which had previously placed study device.The stenosis was treated with percutaneous coronary intervention (pci) and target-vessel revascularization (tvr).Post intervention, residual stenosis was 0%.Non-target vessel revascularization was also performed.At the time of reporting, the event was considered recovering/resolving.Two days later, the subject was discharged.

Manufacturer Narrative

B5.Describe event or problem- corrected and updated.

Event Description

Synergy china registry.It was reported that coronary atherosclerotic heart disease and restenosis occurred.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion 1 was located in the proximal left anterior descending artery (lad) extending up to mid lad with 70 % stenosis and was 47 mm long, with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of 2.50mmx 28 mm stent overlapped with another 2.75 mm x 24 mm synergy stent system.Post-dilatation was performed with 0% residual stenosis.The target lesion 2 was located in the mid left circumflex artery (lcx) with 90% stenosis and was 25mm long, with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 28 mm synergy stent system.Post-dilatation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin, clopidogrel and ticagrelor.In (b)(6) 2020, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.On the following day, the subject was referred for coronary angiography which revealed 85% proximal stenosis in lcx extending up to distal lcx which had previously placed study device.The stenosis was treated with percutaneous coronary intervention (pci) and target-vessel revascularization (tvr).Post intervention, residual stenosis was 0%.Non-target vessel revascularization was also performed.At the time of reporting, the event was considered recovering/resolving.Two days later, the subject was discharged.It was further reported that in (b)(6) 2020, the 85% target lesion was extending to mid lcx and not distal as previously reported.The rationale of intervention was angiographic finding without symptoms or objective 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: 11810076
• MDR Text Key: 250181311
• Report Number: 2134265-2021-05958
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0023017624
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR