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

Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 - date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that stent dislodgement occurred.The calcified nodule target lesion was located in a non-tortuous coronary artery.A 3.00 x 38mm synergy xd drug-eluting stent was advanced for treatment.During insertion, the physician attempted to advance the stent, however, it got stuck and came off in the vessel.The physician decided to deploy the stent at that location.The stent did not travel or move down the artery after it was detached from the stent balloon.The procedure was completed with the original device.There were no patient complications reported.
Additional Manufacturer Narrative
B3 - date of event: used the first date of the month of the aware date as no event date was provided.Investigation results: device analysis findings: the device was implanted and will not be returned for analysis; therefore, a technical analysis could not be performed.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there 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.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 investigation conclusion code of adverse event related to procedure.This code was selected as the most probable complaint cause based on the information available.Based on the event details, it is most likely the stent dislodgement occurred due to procedural factors.These procedural factors would include interactions of the stent with the lesion's anatomical features, as well as interactions with other ancillary devices used during the procedure.
Event or Problem Description
It was reported that stent dislodgement occurred.The calcified nodule target lesion was located in a non-tortuous coronary artery.A 3.00 x 38mm synergy xd drug-eluting stent was advanced for treatment.During insertion, the physician attempted to advance the stent, however, it got stuck and came off in the vessel.The physician decided to deploy the stent at that location.The stent did not travel or move down the artery after it was detached from the stent balloon.The procedure was completed with the original device.There were no patient complications reported.

• 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: 20186580
• Report Number: 2124215-2024-56489
• Device Sequence Number: 8138422
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: 08714729981015
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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?: Yes
• Operator of Device: Health Professional
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 04/21/2026
• 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 Sex: Unknown