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

Model Number	H7493941838220
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported stent malposition occurred.In (b)(6) 2026, the patient was on a prior regimen of antiplatelet medication other than aspirin (great than or equal to 72 hours).The 2.25 mm x 25 mm target lesion was located at the first diagonal artery.The target lesion was pre-treated with a 2.25 mm x 12 mm wolverine and a non-compliant balloon resulting in 30% residual stenosis and timi flow of 3.The 2.25 mm x 38 mm synergy xd stent successfully treated the target lesion resulting in 0% residual stenosis and timi flow 3.On the same day of the procedure, ivus concluded the pre-treatment with the wolverine device demonstrated the presence of medial dissection.Ivus also noted stent malposition with the synergy xd stent.The patient discharged from hospital.On aspirin and clopidogrel.
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.

• 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: 25082282
• Report Number: 2124215-2026-24170
• Device Sequence Number: 13360963
• Product Code: NIQ
• UDI-Device Identifier: 08714729980773
• UDI-Public: (01)08714729980773(17)270902(10)37404442
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 07/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493941838220
• Device Catalogue Number: H7493941838220
• Device Lot Number: 0037404442
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 07/16/2026
• Date Device Manufactured: 09/02/2025
• 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
• Patient Age: 74 YR
• Patient Sex: Male