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

Model Number	H7493941838220
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	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complications occurred.The patient was on gpiib/iiia inhibitors and on prior regimen of aspirin (>= 72 hours) and antiplatelet other than aspirin (>= 72 hours) at the time of the procedure.A loading dose of 300mg of clopidogrel was given prior to the procedure.The 40 mm x 2.00 mm target lesion was located in the first obtuse marginal branch of the left circumflex artery (lcx) and was pre-treated with a 2.00 mm x 30 mm semi-compliant balloon angioplasty catheter resulting in 0% residual stenosis and timi flow 3.The target lesion was then successfully treated with a 2.25 mm x 38 mm synergy xd drug eluting stent resulting in 0% residual stenosis and timi flow of 3.A non-target lesion extending from the distal left anterior descending artery (lad) to the mid lad was successfully treated prior to the treatment of target lesion using a 2.25 mm x 38 mm drug eluting stent and a 2.50 mm x 16 mm drug eluting stent.Post-procedure, elevated cardiac enzymes were detected and the patient was diagnosed with myocardial infarction.The patient was discharged from the hospital with the continuation of aspirin and clopidogrel medications.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6) hospital.

• 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 ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50073594
• Report Number: 2124215-2026-40669
• Device Sequence Number: 10480939
• Product Code: NIQ
• UDI-Device Identifier: 08714729980773
• UDI-Public: (01)08714729980773(17)270902(10)37404442
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 09/10/2026

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: H7493941838220
• Device Catalogue Number: H7493941838220
• Device Lot Number: 0037404442
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 09/02/2025
• 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: 63 YR
• Patient Sex: Female
• Patient Race: White