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

Model Number	H7493941832270
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	05/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported elevated cardiac enzymes and myocardial infarction occurred.The patient was on a prior regimen of aspirin (>= 72 hours) and antiplatelet medication other than aspirin (>= 72 hours).At the time of the procedure, the patient received heparin or other antithrombotic medication.The 2.75 mm x 28 mm target lesion located in the main branch of the proximal left anterior descending vessel (lad) was pretreated with three devices using the largest balloon diameter of 2.5 mm x 12 mm wolverine cutting balloon, semi-compliant balloon angioplasty catheter and non-compliant balloon angioplasty catheter resulting in 30% residual stenosis and timi flow of 3.The lesion was then successfully treated with the 2.75 mm x 32 mm synergy xd drug eluting stent achieving 0% residual stenosis with timi flow of 3.A balloon angioplasty catheter (ptca dilatation catheter) and a non-complaint balloon was used for post dilation as ancillary devices.The 2.5 mm x 20 mm target lesion located in the side branch of the 1st diagonal vessel was pretreated with three devices using the largest balloon diameter of 2.5 mm x 15 mm wolverine cutting balloon, semi-compliant balloon angioplasty catheter and non-compliant balloon angioplasty catheters resulting in 10% residual stenosis and timi flow of 3.The lesion was then successfully treated with the 2.5 mm x 24 mm synergy xd drug eluting stent achieving 0% residual stenosis with timi flow of 3.A 2.75 mm non-complaint balloon was used for post dilation as an ancillary device.At the 3-6-hour time interval post procedure the biomarkers revealed troponin i hs level of 29.44 ng/l (within reference range) and troponin t hs level of 34.90 ng/l (elevated from reference range).During the 18-24-hour post procedure lab draw, results demonstrated increase in the troponin i hs level to 796.36 ng/l (upper limit normal (uln): 47 ng/l) and more than five times increase in the troponin t hs level to 93.20 ng/l (upper limit normal (uln): 14 ng/l).The elevation met the criteria for myocardial infarction.The patient discharged from the hospital with the continuation of aspirin and started 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 ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50550385
• Report Number: 2124215-2026-45884
• Device Sequence Number: 10650997
• Product Code: NIQ
• UDI-Device Identifier: 08714729980926
• UDI-Public: (01)08714729980926(17)271124(10)38116893
• 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): 09/23/2026

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: H7493941832270
• Device Catalogue Number: H7493941832270
• Device Lot Number: 0038116893
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 11/24/2025
• 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: 73 YR
• Patient Sex: Male