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

Device Problem Failure to Advance (2524)

Patient Problems Angina (1710); Restenosis (4576)

Event Date 02/11/2022

Event Type  Injury  

Event Description

Agent ide.It was reported that in-stent restenosis (isr) occurred.On (b)(6) 2017, 80% isr and 90% isr was noted at the proximal right coronary artery (rca) and mid rca respectively.The lesions were successfully treated with a 3.00 mm x 10.00 mm non-boston scientific (bsc) balloon and a 3.00 mm x 38.00 mm synergy stent, resulting in 30% residual stenosis.On (b)(6) 2022, the subject presented to the hospital, complaining chest burning and discomfort (equivalent to stable angina), which were similar to prior episodes.Two days later, the cardiac catheterization revealed 60% isr at the proximal and mid rca.On (b)(6) 2022, the subject presented with stable angina and was referred for the agent ide study.The target lesion was located at the proximal left circumflex (lcx) and was 20 mm long with a reference vessel diameter was 3.0 mm.The target lesion was predilated using a 3.00 mm x 15 mm balloon resulting in 20% residual stenosis and timi flow 3.Following pre-dilation, the lesion was successfully treated with a 3.5 mm x 20 mm nc quantum apex study device with 10% residual stenosis and timi flow 3.The subject was discharged on clopidogrel and aspirin.On (b)(6) 2024, the subject started experiencing symptoms of shortness of breath with exertion, chest pain and fatigue.At the time of the event the subject was on aspirin and clopidogrel.Diagnostic coronary angiography revealed that the 80% stenosis at the 3.0 mm x 38 mm synergy drug eluting stent, 60% stenosis at the proximal rca, 80% stenosis at the distal rca and 90% stenosis at proximal lcx.The subject was diagnosed with worsening coronary artery stenosis and aortic stenosis.On (b)(6) 2024, the subject was hospitalized and recommended for coronary artery bypass graft surgery (cabg).Cabg was performed with saphenous vein graft (svg) to obtuse marginal branch.In addition, cabg was performed at the left internal mammary artery (lima) to the left anterior descending artery (lad) and svg to posterior descending artery (pda).On (b)(6) 2024, the events were considered to be resolved/recovered and the subject was discharged.

• Brand Name: SYNERGY XD
• 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: 19110728
• MDR Text Key: 340232851
• Report Number: 2124215-2024-22724
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/15/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White