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

Model Number 10620

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

Patient Problems Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Restenosis (4576)

Event Date 12/28/2023

Event Type  Injury  

Event Description

Synergy china registry.It was reported that the patient experienced stent thrombosis, acute st elevation myocardial infarction, acute heart failure and target vessel revascularization.In (b)(6) 2020, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal left anterior descending artery (lad) extending up to distal lad with 95% stenosis and was 12 mm long with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of 2.75 mm x 24 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal right coronary artery (rca) with 95% stenosis and was 8 mm long with a reference vessel diameter of 2.25 mm.The target lesion 2 was treated with pre-dilatation and placement of 2.25 mm x 12 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Three days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2023, the subject was diagnosed with stent thrombosis, acute st elevation myocardial infarction (mi) anterior/septal, acute heart failure and target vessel revascularization and was hospitalized on the same day for further evaluation and treatment.Coronary angiography revealed an unobstructed and non-thrombosed rca and a 50% in-stent restenosis in the lad with numerous visible thrombus shadows, and 50% -70% stenosis at the first diagonal (d1) opening.The stenosis noted in proximal lad extending up to middle lad which had previously placed study device was treated with percutaneous coronary intervention (target vessel revascularization).Post intervention, the residual stenosis was noted to be 0%.Thirteen days later in (b)(6) 2024, the events were considered to be recovered and resolved and the subject was discharged on aspirin and ticagrelor.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).

Manufacturer Narrative

E1: initial reporter phone: (b)(6).

Event Description

Synergy china registry: it was reported that the patient experienced stent thrombosis, acute st elevation myocardial infarction, acute heart failure and target vessel revascularization.On (b)(6) 2020, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal left anterior descending artery (lad) extending up to distal lad with 95% stenosis and was 12 mm long with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of 2.75 mm x 24 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal right coronary artery (rca) with 95% stenosis and was 8 mm long with a reference vessel diameter of 2.25 mm.The target lesion 2 was treated with pre-dilatation and placement of 2.25 mm x 12 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Three days later, the subject was discharged on aspirin and ticagrelor.On (b)(6) 2023, the subject was diagnosed with stent thrombosis, acute st elevation myocardial infarction (mi) anterior/septal, acute heart failure and target vessel revascularization and was hospitalized on the same day for further evaluation and treatment.Coronary angiography revealed an unobstructed and non-thrombosed rca and a 50% in-stent restenosis in the lad with numerous visible thrombus shadows, and 50% -70% stenosis at the first diagonal (d1) opening.The stenosis noted in proximal lad extending up to middle lad which had previously placed study device was treated with percutaneous coronary intervention (target vessel revascularization).Post intervention, the residual stenosis was noted to be 0%.Thirteen days later on (b)(6) 2024, the events were considered to be recovered and resolved and the subject was discharged on aspirin and ticagrelor.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18909063
• MDR Text Key: 337729853
• Report Number: 2124215-2024-15697
• 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: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2020
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0023974852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male