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 12/16/2020

Event Type  Injury  

Event Description

Synergy (b)(4) registry it was reported that coronary atherosclerotic heart disease 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 was located in the proximal right coronary artery (rca) extending up to right posterior descending artery (r-pda) with 80% stenosis and was 61 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 28 mm overlapped with another 3.00 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.On the following day, the subject was discharged on aspirin and clopidogrel.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.Percutaneous transluminal coronary angioplasty (ptca) was performed in mid rca and proximal left anterior descending artery (lad).Three days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the event was recovering or resolving.

Event Description

Synergy china registry.It was reported that coronary atherosclerotic heart disease occurred.On (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 was located in the proximal right coronary artery (rca) extending up to right posterior descending artery (r-pda) with 80% stenosis and was 61 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 28 mm overlapped with another 3.00 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.On the following day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Percutaneous transluminal coronary angioplasty (ptca) was performed in mid rca and proximal left anterior descending artery (lad).Three days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the event was recovering or resolving.It was further reported that the event would qualify for clinical events committee (cec)- target vessel revascularization (tvr).On (b)(6) 2020, coronary angiography revealed 90% stenosis in mid rca, which had previously placed study device.It was treated with percutaneous coronary intervention-target vessel revascularization (pci-tvr).Post intervention, residual stenosis was 0%.

Event Description

Synergy china registry: it was reported that coronary atherosclerotic heart disease 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 was located in the proximal right coronary artery (rca) extending up to right posterior descending artery (r-pda) with 80% stenosis and was 61 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 28 mm overlapped with another 3.00 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.On the following day, the subject was discharged on aspirin and clopidogrel.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.Percutaneous transluminal coronary angioplasty (ptca) was performed in mid rca and proximal left anterior descending artery (lad).Three days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the event was recovering or resolving.It was further reported that the event would qualify for clinical events committee (cec)- target vessel revascularization (tvr).In (b)(6) 2020, coronary angiography revealed 90% stenosis in mid rca, which had previously placed study device.It was treated with percutaneous coronary intervention-target vessel revascularization (pci-tvr).Post intervention, residual stenosis was 0%.It was further reported that the rationale for tvr is angina and symptoms of ischemia.Furthermore, it was noted that the vessel treated during baseline surgery was restenosis this time.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11490114
• MDR Text Key: 240030235
• Report Number: 2134265-2021-02821
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0023316214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 04/05/2021; 11/19/2021
• Supplement Dates FDA Received: 04/23/2021; 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female