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

Model Number	H7493941820220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an aneurysm occurred.The patient was on a prior regimen of aspirin (>= 72 hours) and antiplatelet medication other than aspirin (>= 72 hours).Prior to the procedure the patient received heparin, antithrombotic medication and a loading dose of 75 mg of clopidogrel.The 2.75 mm x 18 mm target lesion located at the first obtuse marginal vessel was pre-treated with four devices using the largest balloon diameter of 2.25 mm x 20 mm wolverine and non-compliant balloon angioplasty catheter resulting in 0% residual stenosis and timi flow of 3.The lesion was then successfully treated with the 2.25 mm x 20 mm synergy xd stent demonstrating 0% residual stenosis and timi flow of 3.Post synergy xd stent placement, aneurysm with timi flow 3 was indicated.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 ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 25294494
• Report Number: 2124215-2026-28291
• Device Sequence Number: 18520982
• Product Code: NIQ
• UDI-Device Identifier: 08714729980735
• UDI-Public: (01)08714729980735(17)271218(10)38252596
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/21/2026

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: H7493941820220
• Device Catalogue Number: H7493941820220
• Device Lot Number: 0038252596
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 07/21/2026
• Date Device Manufactured: 12/18/2025
• 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: 79 YR
• Patient Sex: Male
• Patient Race: White