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

Model Number	H7493941838300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a grade c dissection occurred.The 3.0 mm x 36 mm target lesion located at the mid right coronary artery (mid rca) was pretreated with a 3.0 x 15 mm non-compliant balloon angioplasty catheter resulting in 40% stenosis and timi flow 3.The target lesion was then treated with the 3.0 mm x 38 mm synergy xd stent.During the stent placement a stent edge dissection caused by the stent placement occurred.The dissection was a type c that extended into the distal rca and required placement of two stents to resolve the issue.The event was resolved and the patient discharged.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50860042
• Report Number: 2124215-2026-50502
• Device Sequence Number: 9554101
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• 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
• Report Date (Section B): 09/22/2026

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: H7493941838300
• Device Catalogue Number: H7493941838300
• Device Lot Number: 0038398901
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• 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: Required Intervention
• Patient Sex: Unknown