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

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

Patient Problems Angina (1710); Dyspnea (1816); Fatigue (1849); Restenosis (4576)

Event Date 12/06/2022

Event Type  Injury  

Event Description

It was reported that angina occurred.Diagnostic coronary angiography revealed a 90% stenosed target lesion at the ostial to proximal segment of the right coronary artery.The lesion was treated with rotational atherectomy followed by dilation with a non-boston scientific balloon.Intravascular lithotripsy was completed with a non-boston scientific balloon.A 4.50 x 15 emerge was selected to treat the lesion followed by laser atherectomy.Optical coherence tomography revealed a large degree of dissected neointimal tissue and a 4.00 x 48 synergy was deployed.The stent was post-dilated with a 4.50 x 12 non-compliant balloon and brachytherapy was performed.Post revascularization, 10% residual stenosis with thrombolysis in myocardial infarction (timi) flow 3 was noted.After the procedure, the patient experienced minor right sided chest discomfort.

Event Description

It was reported that angina occurred.On (b)(6) 2022 diagnostic coronary angiography revealed a 90% stenosed target lesion at the ostial to proximal segment of the right coronary artery.The lesion was treated with rotational atherectomy followed by dilation with a non-boston scientific balloon.Intravascular lithotripsy was completed with a non-boston scientific balloon.A 4.50 x 15 emerge was selected to treat the lesion followed by laser atherectomy.Optical coherence tomography revealed a large degree of dissected neointimal tissue and a 4.00 x 48 synergy was deployed.The stent was post-dilated with a 4.50 x 12 non-compliant balloon and brachytherapy was performed.Post revascularization, 10% residual stenosis with thrombolysis in myocardial infarction (timi) flow 3 was noted.After the procedure, the patient experienced minor right sided chest discomfort.It was further reported that on (b)(6) 2023 subject started experiencing cardiac symptoms associated with shortness of breath and dyspnea without chest pain.Diagnostic coronary angiography revealed 80% ostial stenosis of the rca and the subject was diagnosed with coronary artery diseases and aortic stenosis.On (b)(6) 2023 the subject presented with worsening symptoms of shortness of breath and fatigue.A coronary artery bypass graft procedure was performed to treat the stenosis.The subject also had an aortic valve replacement for the severe aortic stenosis.On (b)(6) 2023 the coronary artery disease and aortic stenosis were considered resolved, but the shortness of breath and fatigue persisted.

• 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: 16404994
• MDR Text Key: 309860693
• Report Number: 2124215-2023-07685
• 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,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• 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
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Race: White