MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10601

Device Problem Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Restenosis (4576)

Event Date 04/13/2023

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier: (b)(6).

Event Description

Evolve_lv_clv clinical stud.It was reported that myocardial infarction and in-stent restenosis (isr) occurred.On (b)(6) 2021, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending artery (lad) with 80% stenosis and was 16 mm long with a reference vessel diameter of 5.3 mm and timi flow of 3.The target lesion was treated with pre-dilation and placement of a 4.00 mm x 20 mm study stent.Following post-dilation, residual stenosis was 0% with timi flow of 3.In addition, a non-target lesion located in mid lad extending to distal lad was treated with placement of a 2.50 mm x 16 mm synergy drug eluting stent (des).A second non-target lesion located in 1st diagonal artery was treated with a 2.25 mm x 12 mm synergy des.The subject was discharged on aspirin and clopidogrel.On (b)(6) 2023, the subject presented in the emergency department (ed) with pressure-like substernal chest pain radiating to bilateral arms and lasting 40 minutes in duration with associated shortness of breath.The subject took nitroglycerine which did not provide complete pain relief and paramedics had given the subject 324mg of aspirin during transport to the ed.Cardiac enzymes were found to be elevated and electrocardiography revealed av-paced rhythm, st depression and t wave inversion in lateral leads with no clear ischemic changes or notable ectopy.The subject was diagnosed with non-q wave myocardial infarction and underwent several diagnostic tests.A chest x-ray revealed mild cardiomegaly, no focal consolidation or pulmonary edema, no pleural effusion or pneumothorax, and no acute pulmonary disease.Transthoracic echocardiography (tte) revealed markedly dilated left ventricle, mild left ventricular hypertrophy (lvh), severely decreased lv systolic function with lv ejection fraction of 15-20% with severe global hypokinesis, mild mitral regurgitation, and mild to moderate aortic insufficiency.The subject was hospitalized on the same day and started on heparin, gtt, aspirin, atrovastatin, plavix, and metropropol.The next day the subject underwent coronary angiography and, given the degree of multivessel progression, the subject was transferred to another hospital for complex percutaneous coronary intervention (pci) vs coronary artery bypass graft (cabg) evaluation.The subject was evaluated and deemed too high risk for surgery.On (b)(6) 2023, the 90% isr in the proximal lad was treated with balloon dilation using a 3.25mm non-compliant (nc) balloon from the left main coronary artery (lmca) into the lad followed by placement of a 4mm x 15mm non-boston scientific drug eluting stent from the mid lcma into the proximal lad.Following post dilation with a 4mm nc balloon, the final residual stenosis was noted to be 0% with timi flow 3.The event was considered resolved and the subject was discharged on dual antiplatelet therapy.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 17780482
• MDR Text Key: 323827693
• Report Number: 2124215-2023-48637
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P150003
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0025260514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• 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): Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: White