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

Model Number 9531

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

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 01/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Synergy china registry.It was reported that coronary atherosclerotic heart disease occurred.In (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the proximal right coronary artery (rca) extending up to middle rca with 99% stenosis and was 54 mm long with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 mm x 32 mm overlapped on to 3.50 mm x 28 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.In (b)(6) 2020, a staged procedure was performed, target lesion 1 located in the proximal left anterior descending artery (lad) extending up to middle lad with 90% stenosis and was 66 mm long with a reference vessel diameter of 2.75 mm.The target lesion 1 was treated with pre-dilatation and placement of a 2.50 mm x 38 mm overlapped on to 2.75 mm x 32 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.The target lesion 2 was located in the distal rca extending up to middle rca with 95% stenosis and was 46 mm long with a reference vessel diameter of 2.75 mm.The target lesion 2 was treated with pre-dilatation and placement of a 2.50 mm x 38 mm overlapped on to 2.75 mm x 12 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.Three days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2022, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on same day for further treatment.Angiography without revascularization was performed.No other action was taken to treat the event.Three days later, the event was considered to be recovered/resolved and on the same day the subject was discharged on aspirin and ticagrelor.

Event Description

Synergy china registry.It was reported that coronary atherosclerotic heart disease occurred.On (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the proximal right coronary artery (rca) extending up to middle rca with 99% stenosis and was 54 mm long with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 mm x 32 mm overlapped on to 3.50 mm x 28 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.On (b)(6) 2020, a staged procedure was performed, target lesion 1 located in the proximal left anterior descending artery (lad) extending up to middle lad with 90% stenosis and was 66 mm long with a reference vessel diameter of 2.75 mm.The target lesion 1 was treated with pre-dilatation and placement of a 2.50 mm x 38 mm overlapped on to 2.75 mm x 32 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.The target lesion 2 was located in the distal rca extending up to middle rca with 95% stenosis and was 46 mm long with a reference vessel diameter of 2.75 mm.The target lesion 2 was treated with pre-dilatation and placement of a 2.50 mm x 38 mm overlapped on to 2.75 mm x 12 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.Three days later, the subject was discharged on aspirin and ticagrelor.On (b)(6) 2022, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on same day for further treatment.Angiography without revascularization was performed.No other action was taken to treat the event.Three days later, the event was considered to be recovered/resolved and on the same day the subject was discharged on aspirin and ticagrelor.It was further reported that target lesion 2 was located in the proximal left circumflex (lcx) artery extending first obtuse marginal and not middle rca extending to distal rca as previously reported.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16040558
• MDR Text Key: 306061883
• Report Number: 2124215-2022-53143
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9531
• Device Catalogue Number: 9531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 40 YR
• Patient Sex: Male