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

Model Number	H7493941816220
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that detachment occurred.The 2.25 x 16mm synergy xd drug eluting stent was selected for treatment of the target lesion located in a mildly tortuous vessel.The device was advanced and removed without complication or damage.Following additional pre-dilation, the stent was re-advanced.It became apparent that further pre-dilation was required.During removal of the stent, approximately one-quarter of the stent sheared off.The remaining three-quarters of the stent, still on the balloon, was removed intact.The sheared off portion of the stent remained in the vessel and was successfully dilated using a balloon advanced over the exiting wire.The patient remained stable throughout the procedure and is expected to fully recover.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned; therefore, a technical analysis could not be performed.Device history record review: this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable conclusion code of cause not established.This code was selected as the most probable complaint cause based on the investigation conducted.Based on the complaint information available and the fact that no device or image form the procedure was received for review, it is not possible to establish with certainty what the cause of the reported complaint was.
Event or Problem Description
It was reported that detachment occurred.The 2.25 x 16mm synergy xd drug eluting stent was selected for treatment of the target lesion located in a mildly tortuous vessel.The device was advanced and removed without complication or damage.Following additional pre-dilation, the stent was re-advanced.It became apparent that further pre-dilation was required.During removal of the stent, approximately one-quarter of the stent sheared off.The remaining three-quarters of the stent, still on the balloon, was removed intact.The sheared off portion of the stent remained in the vessel and was successfully dilated using a balloon advanced over the exiting wire.The patient remained stable throughout the procedure and is expected to fully recover.It was further reported that the target lesion was 90% stenosed and calcified.The proximal section of the stent was removed entirely on the delivery balloon and the distal section remained in the patient.
Event or Problem Description
It was reported that detachment occurred.The 2.25 x 16mm synergy xd drug eluting stent was selected for treatment of the target lesion located in a mildly tortuous vessel.The device was advanced and removed without complication or damage.Following additional pre-dilation, the stent was re-advanced.It became apparent that further pre-dilation was required.During removal of the stent, approximately one-quarter of the stent sheared off.The remaining three-quarters of the stent, still on the balloon, was removed intact.The sheared off portion of the stent remained in the vessel and was successfully dilated using a balloon advanced over the exiting wire.The patient remained stable throughout the procedure and is expected to fully recover.It was further reported that the target lesion was 90% stenosed and calcified.The proximal section of the stent was removed entirely on the delivery balloon and the distal section remained in the patient.

• 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: 24509112
• Report Number: 2124215-2026-12141
• Device Sequence Number: 10025523
• Product Code: NIQ
• UDI-Device Identifier: 08714729980728
• UDI-Public: (01)08714729980728(17)260812(10)34648268
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

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 Expiration Date: 08/12/2026
• Device Model Number: H7493941816220
• Device Catalogue Number: H7493941816220
• Device Lot Number: 0034648268
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 04/03/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/02/2026; 04/17/2026
• Date Device Manufactured: 08/12/2024
• 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