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

Model Number	H7493941820250
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
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 dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 2.50 x 20 mm synergy xd drug-eluting stent was selected for treatment.During preparation, when the stent was loaded onto the wire, the stent separated from the balloon without the balloon being inflated.The stent was not inserted into the body.Another synergy stent was used to complete the procedure successfully.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.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record review: it was confirmed that this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations that 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 investigation conclusion code of cause not established.This conclusion code is based on the available information and the record review conducted at the boston scientific site.Based on the limited available information it cannot be assessed at this time what may have contributed to the reported issue and the cause cannot be established.A review of the product record did not identify any issues during the manufacturing of the finished goods batch which may have contributed to the event.One possible explanation is that unintentionally excessive force was applied to the device while removing the mandrel and stent protector leading to the stent dislodgement, but this cannot be confirmed.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 2.50 x 20mm synergy xd drug-eluting stent was selected for treatment.During preparation, when the stent was loaded onto the wire, the stent separated from the balloon without the balloon being inflated.The stent was not inserted into the body.Another synergy stent was used to complete the procedure successfully.There were no patient complications, and the patient fully recovered.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record review: it was confirmed that this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations that 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 investigation conclusion code of cause not established.This conclusion code is based on the available information and the record review conducted at the boston scientific site.Based on the limited available information it cannot be assessed at this time what may have contributed to the reported issue and the cause cannot be established.A review of the product record did not identify any issues during the manufacturing of the finished goods batch which may have contributed to the event.One possible explanation is that unintentionally excessive force was applied to the device while removing the mandrel and stent protector leading to the stent dislodgement, but this cannot be confirmed.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 2.50 x 20mm synergy xd drug-eluting stent was selected for treatment.During preparation, when the stent was loaded onto the wire, the stent separated from the balloon without the balloon being inflated.The stent was not inserted into the body.Another synergy stent was used to complete the procedure successfully.There were no patient complications, and the patient fully recovered.It was further reported that the stent protector was removed first during unpacking and there was no resistance encountered during removal.

• 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: 24548003
• Report Number: 2124215-2026-12903
• Device Sequence Number: 9485867
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: (01)08714729980810(17)270819(10)37330180
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 05/05/2026

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: H7493941820250
• Device Catalogue Number: H7493941820250
• Device Lot Number: 0037330180
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/10/2026; 05/05/2026
• Date Device Manufactured: 08/19/2025
• 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