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

Model Number	H7493941820400
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that an inflation issue resulted in a dissection.The target lesion was located in the distal right coronary artery (rca).A 4.00 x 12mm synergy xd drug-eluting stent (des) was initially deployed.However, during inflation with the encore indeflator, the proximal end of the balloon appeared to inflate higher than the distal edge, resulting in a proximal edge dissection.The dissection was non-flow limiting and graded as type a.Subsequently, a second 4.00 x 20mm synergy xd des was deployed, but it also contributed to additional dissection in the distal rca.An additional stent was then placed to cover the dissected area and complete the procedure.The patient made a full recovery, remained stable, and no other issues were reported.

• 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: 22457984
• Report Number: 2124215-2025-43952
• Device Sequence Number: 8598080
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: (01)08714729981138(17)261111(10)35350719
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

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: H7493941820400
• Device Catalogue Number: H7493941820400
• Device Lot Number: 0035350719
• 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: 06/12/2025
• Initial Report FDA Received Date: 07/09/2025
• Date Device Manufactured: 11/11/2024
• 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: Required Intervention
• Patient Sex: Unknown