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

Device Problem Activation Failure (3270)

Patient Problems Angina (1710); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Fatigue (1849); Ischemia (1942); Myocardial Infarction (1969); Restenosis (4576)

Event Date 02/28/2022

Event Type  Injury  

Event Description

It was reported that in-stent restenosis (isr) occurred.On (b)(6) 2021, coronary angiography revealed 80% stenosis at the proximal left anterior descending artery (lad).A 3.00 mm x 38 mm synergy drug eluting stent was implanted as treatment during percutaneous coronary intervention.On (b)(6) 2022, that subject presented with stable angina and intravascular ultrasound revealed under expansion of the previously placed synergy drug eluting stent.Additionally, diagnostic angiography revealed 90% in-stent restenosis of the previously placed synergy drug eluting stent (due to under-expansion).The subject was randomized into the agent ide study on (b)(6) 2022 and the index procedure was performed on the same day.The subject was on a prior regimen of aspirin (>= 72 hours) and antiplatelet medication other than aspirin (>= 72 hours), at the time of index procedure.A loading dose of aspirin 243 mg was given prior to the procedure.Heparin or other antithrombotic medication were administered at the time of index procedure.The target lesion was located at the proximal lad and was 20 mm long with a reference vessel diameter of 4 mm.The target lesion was predilated with a 4.50 mm x 18 mm balloon with 0% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was treated with a 4.00 mm x 20 mm non-boston scientific balloon successfully with 0% residual stenosis and timi flow of 3.The subject was discharged on prasugrel and aspirin.On (b)(6) 2022, the subject presented to the hospital with the complaint of chest pain and shortness of breath while walking.Electrocardiography revealed inferior infarct and mild st depression with negative troponin.The subject also had moderate anterolateral ischemia.At the time of the event, the subject was on aspirin and prasugrel, which were continued.Exercise stress test and lab test were performed and the subject was recommended for cardiac catheterization.On (b)(6) 2022, coronary angiography revealed 70% isr of the proximal lad with moderate diffuse disease and mild calcification.The subject was diagnosed with severe multivessel coronary artery disease and the chest pain symptom was assessed as typical angina.The 70% stenosis at the target lesion was predilated using a 4.00mm x 20mm nc emerge and a 3.50mm x 10mm wolverine balloon and was followed by implanting a 4.00 mm x 30 mm non-boston scientific stent.Post dilation was performed with a 4,00 mm x 20 mm nc emerge balloon resulting in 0% stenosis and timi flow 3.The event was considered recovered/resolved.

Event Description

It was reported that in-stent restenosis (isr) occurred.On 12-jul-2021, coronary angiography revealed 80% stenosis at the proximal left anterior descending artery (lad).A 3.00 mm x 38 mm synergy drug eluting stent was implanted as treatment during percutaneous coronary intervention.On (b)(6) 2022 that subject presented with stable angina and intravascular ultrasound revealed under expansion of the previously placed synergy drug eluting stent.Additionally, diagnostic angiography revealed 90% in-stent restenosis of the previously placed synergy drug eluting stent (due to under-expansion).The subject was randomized into the agent ide study on (b)(6) 2022 and the index procedure was performed on the same day.The subject was on a prior regimen of aspirin (>= 72 hours) and antiplatelet medication other than aspirin (>= 72 hours), at the time of index procedure.A loading dose of aspirin 243 mg was given prior to the procedure.Heparin or other antithrombotic medication were administered at the time of index procedure.The target lesion was located at the proximal lad and was 20 mm long with a reference vessel diameter of 4 mm.The target lesion was predilated with a 4.50 mm x 18 mm balloon with 0% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was treated with a 4.00 mm x 20 mm non-boston scientific balloon successfully with 0% residual stenosis and timi flow of 3.On (b)(6) 2022 the subject was discharged on prasugrel and aspirin.On (b)(6) 2022 the subject presented to the hospital with the complaint of chest pain and shortness of breath while walking.Electrocardiography revealed inferior infarct and mild st depression with negative troponin.The subject also had moderate anterolateral ischemia.At the time of the event, the subject was on aspirin and prasugrel, which were continued.Exercise stress test and lab test were performed and the subject was recommended for cardiac catheterization.On (b)(6) 2022 coronary angiography revealed 70% isr of the proximal lad with moderate diffuse disease and mild calcification.The subject was diagnosed with severe multivessel coronary artery disease and the chest pain symptom was assessed as typical angina.The 70% stenosis at the target lesion was predilated using a 4.00 mm x 20 mm nc emerge and a 3.50 mm x 10 mm wolverine balloon and was followed by implanting a 4.00 mm x 30 mm non-boston scientific stent.Post dilation was performed with a 4,00 mm x 20 mm nc emerge balloon resulting in 0% stenosis and timi flow 3.The event was considered recovered/resolved.It was further reported that fatigue was also experienced when the subject presented to the hospital on (b)(6) 2022.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16644456
• MDR Text Key: 312334032
• Report Number: 2124215-2023-14491
• 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: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: White