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

Model Number	H7493941820250
Medical Device Problem Codes	Device Damaged by Another Device (2915); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a stent migration occurred.An opticross hd imaging catheter was selected for intravascular ultrasound examination.After placement of the synergy xd 2.5 x 20 stent, ivus examination was performed, and it was noted that the ivus catheter became stuck within the stent.It could neither be advanced nor withdrawn; therefore, the proximal portion was cut, and the imaging core was removed, and an 0.018-inch guidewire was inserted.The entrapment was then resolved, but the stent had migrated.It was noted that during the procedure the ivus catheter was kinked.The procedure was completed.No patient complications were reported.
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Risk review: a risk review was performed, and it confirmed that the event is 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 an acceptable risk benefit profile for the product.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.Investigation conclusion: the conclusion code adverse event related to procedure was selected as the most probable complaint cause based on the information available.Based on the reported event, the most likely contributing factors include procedure related challenges such as device to device interaction and or the application of excessive force during attempts to free the entrapped imaging catheter.These factors likely led to the stent being damaged, dislodged from its position, and migrating post deployment.No evidence was identified to suggest a manufacturing or design deficiency related to the device.
Event or Problem Description
It was reported that a stent migration occurred.An opticross hd imaging catheter was selected for intravascular ultrasound examination.After placement of the synergy xd 2.5 x 20 stent, ivus examination was performed, and it was noted that the ivus catheter became stuck within the stent.It could neither be advanced nor withdrawn; therefore, the proximal portion was cut, and the imaging core was removed, and an 0.018-inch guidewire was inserted.The entrapment was then resolved, but the stent had migrated.It was noted that during the procedure the ivus catheter was kinked.The procedure was completed.No patient complications were 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: 24318259
• Report Number: 2124215-2026-07851
• Device Sequence Number: 4941468
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: (01)08714729980810
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H7493941820250
• Device Catalogue Number: H7493941820250
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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: Required Intervention
• Patient Sex: Unknown