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

Model Number 10622

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

Patient Problems Atherosclerosis (1728); Reocclusion (1985); Complaint, Ill-Defined (2331); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 08/19/2020

Event Type  Injury  

Event Description

(b)(6) registry clinical.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.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 symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.

Event Description

Synergy china registry clinical.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.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 symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.It was further reported that in (b)(6) 2020, the balloon dilatation performed was considered non-target vessel revascularization (non-tvr).

Event Description

Synergy china registry clinical.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.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 symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.It was further reported that in (b)(6) 2020, the balloon dilatation performed was considered non-target vessel revascularization (non-tvr).It was further reported that balloon dilatation performed was considered target vessel revascularization (tvr).It was further reported that in (b)(6) 2020, 85% stenosis noted in proximal rca extending up to middle rca which previously had the study device was treated with percutaneous coronary intervention (pci).Post intervention, residual stenosis was 0%.

Event Description

Synergy china registry clinical.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.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 symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.It was further reported that in (b)(6) 2020, the balloon dilatation performed was considered non-target vessel revascularization (non-tvr).It was further reported that balloon dilatation performed was considered target vessel revascularization (tvr).

Manufacturer Narrative

H6: codes corrected from fda codes to imdrf codes.

Event Description

Synergy china registry clinical.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.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 symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.It was further reported that in (b)(6) 2020, the balloon dilatation performed was considered non-target vessel revascularization (non-tvr).It was further reported that balloon dilatation performed was considered target vessel revascularization (tvr).It was further reported that in (b)(6) 2020, 85% stenosis noted in proximal rca extending up to middle rca which previously had the study device was treated with percutaneous coronary intervention (pci).Post intervention, residual stenosis was 0%.

Manufacturer Narrative

B5 - describe event or problem has been updated.B7 - other relevant history has been updated.Corrections: h6: codes corrected from fda codes to imdrf codes.

Event Description

Synergy china registry clinical it was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In october 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.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 symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.It was further reported that in (b)(6) 2020, the balloon dilatation performed was considered non-target vessel revascularization (non-tvr).It was further reported that balloon dilatation performed was considered target vessel revascularization (tvr).It was further reported that in (b)(6) 2020, 85% stenosis noted in proximal rca extending up to middle rca which previously had the study device was treated with percutaneous coronary intervention (pci).Post intervention, residual stenosis was 0%.It was further reported that in october 2019, the mid left circumflex (lcx) artery extending up to distal lcx (non-tvr) was also treated.Furthermore, in august 2020, the rationale of intervention was angina and symptoms of ischemia and the subject was discharged on aspirin and clopidogrel.

• 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: 10817455
• MDR Text Key: 215537074
• Report Number: 2134265-2020-15616
• 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,Followup
• Report Date: 09/30/2021

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: 08/02/2020
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0023325130
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR