MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY? XD; coronary drug-eluting stent

Model Number	H7493941820220
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.During the procedure, a 7f guide catheter and a guidezilla ii guide extension catheter were used.After the lesion was pre-dilated with a 2.00mm emerge balloon catheter, a 2.25 x 20mm synergy? xd was advanced for treatment.During insertion, the stent got caught on the guidezilla and started to dislodge from the delivery system.The physician removed the delivery system, and guide extension together, retrieving the dislodged stent with no stent left behind.The guidezilla was reinserted, and a new stent was then introduced and successfully deployed.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.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50877502
• Report Number: 2124215-2026-50842
• Device Sequence Number: 9380502
• Product Code: NIQ
• UDI-Device Identifier: 08714729980735
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: H7493941820220
• Device Catalogue Number: H7493941820220
• Device Lot Number: 0039065088
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 03/31/2026
• 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
• Patient Sex: Unknown