MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY? XD; coronary drug-eluting stent

Model Number	H7493941824250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that elevated cardiac enzymes and myocardial infarction occurred.At the time of the procedure, the patient received heparin or other antithrombotic medication, gp iib/iiia inhibitor and a loading dose of 325 mg of aspirin and 75 mg of clopidogrel.The 2.75 mm x15 mm target lesion located at the mid-left anterior descending vessel was pretreated with a 2.5 mm x 20 mm non-complaint balloon angioplasty catheter resulting in 0% stenosis and timi flow 3.The target lesion was then successfully treated with a 2.5 mm x 25 mm synergy xd drug eluting stent achieving 0% stenosis and timi flow 3.After the stent placement, the lesion was treated with an ancillary device: balloon angioplasty catheter (nc emerge).In addition, prior to the target lesion treatment, the non-target lesion extending from the proximal circumflex vessel to the first obtuse marginal vessel was successfully treated with the following devices: 3.0 mm x 15 mm, 3.5 mm x 12 mm, 2.5 mm x 20 mm balloon angioplasty catheters; 4.0 mm x 12 mm ivl; 3.5 mm x 16 mm drug eluting stent and 2.5 mm x 20 mm agent dcb.The core lab noted at the 3-6 hour post procedure lab draw, results demonstrated an elevated level of troponin t hs (128 ng/l) which met the criteria for myocardial infarction.The patient was started on clopidogrel and discharged the day after the procedure with the continuation of aspirin and clopidogrel.

• Brand Name: SYNERGY? XD
• Common Device Name: 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50551622
• Report Number: 2124215-2026-45873
• Device Sequence Number: 10384209
• Product Code: NIQ
• UDI-Device Identifier: 08714729980827
• UDI-Public: (01)08714729980827(17)270429(10)36500930
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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 Model Number: H7493941824250
• Device Catalogue Number: H7493941824250
• Device Lot Number: 0036500930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 04/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Race: White