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	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.
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.
Additional Manufacturer Narrative
Investigation results device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed and confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific has assigned an investigation conclusion code of adverse event related to patient condition based upon the information available.It was reported that elevated cardiac enzymes and myocardial infarction occurred.It is likely that the serious injury, illness or impairment was a result of the patients condition and medical history.The event of myocardial infarction is listed as a known adverse event associated with device use and elevated cardiac enzymes are a key indicator of a myocardial infarction.The product record review confirmed that this is not a new failure type, and the risk is anticipated.

• 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: 50550334
• Report Number: 2124215-2026-45882
• Device Sequence Number: 10266388
• Product Code: NIQ
• UDI-Device Identifier: 08714729980827
• UDI-Public: (01)08714729980827(17)280113(10)38398904
• 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): 09/25/2026

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: 0038398904
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 01/13/2026
• 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