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 Chest Pain (1776); Myocardial Infarction (1969); Restenosis (4576)

Event Date 03/17/2024

Event Type  Injury  

Event Description

(b)(6) study.It was reported that myocardial infarction, occlusion and in-stent restenosis (isr) occurred.On (b)(6) 2022, a 2.50 mm x 12 mm and 3.00 mm x 16 mm promus elite drug eluting stents implanted at the distal left circumflex artery (lcx).On (b)(6) 2023, a 3.50 mm x 28 mm synergy stent was implanted at the first obtuse marginal artery (om1).On (b)(6) 2024, the subject presented to emergency department with chief complaint of worsening chest pain prior to arrival for which nitroglycerine and 81 mg aspirin was taken.At the time of event, subject was on aspirin and clopidogrel.The subject was diagnosed with non-st elevation myocardial infarction.The location of myocardial infarction was inferior and lateral and was unknown q wave mi.On (b)(6) 2024, diagnostic coronary angiography revealed 100% occlusion of the mid lcx stent in the proximal segment after the origin of om1 and severe isr in the proximal segment of the saphenous vein graft (svg) to om graft.The 90% isr noted in the svg-om graft was initially dilated with 2.50 mm x 15 mm, 3.00 mm x 20 mm and 3.50 mm x 15 mm nc balloons.The same lesion was treated with a 3.00 mm x 15 mm wolverine cutting balloon and a 3.50 mm x 15 mm nc balloon.Ivus at this point revealed neointimal hyperplasia at the svg-om graft which was previously treated with the 3.50 mm x 28 mm synergy stent.Finally, the lesion was treated with a 3.00 mm x 24 mm synergy drug eluting stent and post dilation was performed with 3.50 mm x 20 mm nc balloons.The residual stenosis was 0% stenosis.The event was considered as recovered/resolved.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: 19110597
• MDR Text Key: 340238300
• Report Number: 2124215-2024-22706
• 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

• Date FDA Received: 04/15/2024
• 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: 03/27/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White