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

Model Number	H7493941828300
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2025
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 shaft break occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in a severely tortuous and severely calcified coronary artery.A 3.00 x 28mm synergy? xd drug-eluting stent was successfully deployed.Upon retraction of the stent delivery system, the balloon fractured off, and both radiopaque markers remained inside the patient.An attempt was made to retrieve the detached component using a snare, but this was unsuccessful.The procedure was completed using the original device, and no patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in a severely tortuous and severely calcified obtuse marginal artery.A 3.00 x 28mm synergy? xd drug-eluting stent was successfully deployed at nominal pressure.Upon retraction of the stent delivery system, the balloon fractured off, and both radiopaque markers remained inside the patient.An attempt was made to retrieve the detached component using a snare, but this was unsuccessful.The procedure was completed using the original device, and no patient complications were reported.It was further reported via medwatch mw5178759 that the target lesion in the obtuse marginal artery was prepared using a lithotripsy balloon and balloon angioplasty.When an attempt was made to remove the delivery system, it broke off in the circumflex artery and could not be retrieved.

• 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: 23698378
• Report Number: 2124215-2025-86985
• Device Sequence Number: 16046130
• Product Code: NIQ
• UDI-Device Identifier: 08714729980995
• UDI-Public: (01)08714729980995(17)270225(10)36010483
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/29/2025

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: H7493941828300
• Device Catalogue Number: H7493941828300
• Device Lot Number: 0036010483
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 02/25/2025
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Race: White