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

Model Number	H7493941848400
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent move on balloon occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.00 x 48mm synergy xd drug-eluting stent (des) was selected for use.However, when the package was opened and removed the device from the hoop, the stent was already accordioned off of the balloon.A new 4.00 x 48mm synergy xd des was then used to complete the procedure.There were no patient complications and the patient fully recovered.
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 stent move on balloon occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.00 x 48mm synergy xd drug-eluting stent (des) was selected for use.However, when the package was opened and removed the device from the hoop, the stent was already accordioned off of the balloon.A new 4.00 x 48mm synergy xd des was then used to complete the procedure.There were no patient complications and the patient fully recovered.
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: 24292083
• Report Number: 2124215-2026-07109
• Device Sequence Number: 18474696
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: (01)08714729985242(17)270811(10)37217408
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: H7493941848400
• Device Catalogue Number: H7493941848400
• Device Lot Number: 0037217408
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/06/2026
• 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
• Patient Sex: Unknown