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

Model Number	H7493941838250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Heart Failure/Congestive Heart Failure (4446); Restenosis (4576)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
Evolve lv xlv study.It was reported that myocardial infarction (mi) and restenosis occurred.On (b)(6) 2021, the subject presented with stable angina (ccs classification: iii) and was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending artery (lad) with 70% stenosis and was 15 mm long with a reference vessel diameter of 4.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.50 mm x 16 mm study stent.Following post-dilatation, residual stenosis was 0% with timi flow 3.Non-target lesions in the mid lad extending to the first diagonal were treated with placement of 2.50 mm x 16 mm, 2.50 mm x 38 mm, 2.50 mm x 38 mm and 3.00 mm x 48 mm synergy stents in the overlapping manner.The subject was discharged on aspirin and ticagrelor.On (b)(6) 2022, the subject presented at the emergency department via emergency medical services (ems) with complaints of sudden onset of mid chest pain radiating to neck and jaw with associated shortness of breath that began while walking to his truck which improved with a dose of sublingual nitroglycerine.The subject was administered aspirin and sublingual nitroglycerine by ems which alleviated the pain and it was reported that he experienced no chest pain after the second dose of nitroglycerine.On arrival at the emergency department, the subject was administered heparin bolus and drip was started.The subject was diagnosed with non-q wave mi based on symptoms, biomarker elevation, electrocardiography (ecg) changes and angiography.The location of the mi was anterior (septal) and lateral.The subject was hospitalized for further medical evaluation and was recommended for left heart catheterization, to continue heparin drip along with home medications aspirin, losartan, toprol xl, rosuvastatin, brilinta.In addition, for acute on chronic heart failure the subject was advised to take iv lasix 40 mg bid and supplemental oxygen.The subject was advised for cts (cardiovascular and thoracic surgery) evaluation for cabg surgery.In addition, subject was scheduled for endoscopy for anemia.On (b)(6) 2022 the occlusion noted in the lad was accessed by sternotomy and treated with bypass surgery using left internal mammary artery (lima) to lad anastomosis.In, addition, stenosis noted in right coronary artery and left circumflex were treated with bypass surgery using saphenous vein graft (svg) to posterior descending artery (pda) anastomosis and svg to intramyocardial obtuse marginal anastomosis respectively.Satisfactory surgical hemostasis was achieved post grafting using protamine.Post procedure, the subject was transferred to the intensive care unit in stable condition on low dose of inotropes and low dose of vasopressor.The subject was weaned and extubated from the ventricular without difficulty and when deemed medically appropriate, the subject was transferred to the telemetry stepdown unit, where the subject remained stable free from significant dysrhythmias.The subject was advised to continue aspirin, statin, beta blocker, brillinta and was advised to start oral lasix 40 mg daily for a month.On (b)(6) 2022, the subject was discharged from the hospital and the event was considered to be recovering/resolving.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15052898
• Report Number: 2134265-2022-07982
• Device Sequence Number: 5515697
• Product Code: NIQ
• UDI-Device Identifier: 08714729980858
• UDI-Public: 08714729980858
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: H7493941838250
• Device Lot Number: 0026305729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Race: White