MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY? XD; CORONARY DRUG-ELUTING STENT

Model Number	H7493941838350
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Codes	Hematoma (1884); Vascular Dissection (3160)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a dissection and hematoma occured.In (b)(6) 2026, the patient presented with stenosis of the proximal left anterior descending artery (lad).Following pre-dilation using a balloon, the lad was treated with a 3.50 x 38mm synergy xd stent.During treatment, a dissection and hematoma were noted, however following the procedure the patient showed 0% residual stenosis with timi flow 3.The patient was discharged on aspirin and prasugrel.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes: device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the event.Device technical analysis: the device was not returned to the complaint investigation site for analysis.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: the stent was implanted therefore the reported event cannot be confirmed.Malapposition, dissection and hematoma are known inherent risks of interventional cardiology and are listed within the ifu as potential outcome with the use of this coronary stent.This investigation is assigned a most probable investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported a dissection and hematoma occurred.In (b)(6) 2026, the patient presented with stenosis of the proximal left anterior descending artery (lad).Following pre-dilation using a balloon, the lad was treated with a 3.50 x 38mm synergy xd stent.During treatment, a dissection and hematoma were noted, however following the procedure the patient showed 0% residual stenosis with timi flow 3.The patient was discharged on aspirin and prasugrel.It was further reported that stent malapposition occurred during the procedure.

• 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 ; 7634941632
• MDR Report Key: 24731514
• Report Number: 2124215-2026-17223
• Device Sequence Number: 21398780
• Product Code: NIQ
• UDI-Device Identifier: 08714729981091
• UDI-Public: (01)08714729981091(17)270811(10)37304792
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493941838350
• Device Catalogue Number: H7493941838350
• Device Lot Number: 0037304792
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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: 59 YR
• Patient Sex: Male