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

Model Number	H7493941820300
Medical Device Problem Codes	Nonstandard Device (1420); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dislodgement occurred.A 3.00 x 20mm synergy? xd drug-eluting stent was selected for treatment.However, upon unpacking, it was noticed that there was no stent present on the balloon.The procedure was completed with a different device without any patient complications reported.The patient has fully recovered.
Event or Problem Description
It was reported that dislodgement occurred.A 3.00 x 20mm synergy? xd drug-eluting stent was selected for treatment.However, upon unpacking, it was noticed that there was no stent present on the balloon.The procedure was completed with a different device without any patient complications reported.The patient has 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 3.00 x 20mm synergy xd mr stent delivery system was returned for analysis.A visual and tactile examination of the balloon cones were reviewed and were not subjected to positive pressure and multiple kinks were identified along the hypotube shaft.A detailed microscopic examination of the balloon cones were reviewed and were not subjected to positive pressure.The stent was not crimped onto the balloon or returned for analysis.Crimp markings were visible on the balloon and no kinks or damages on the shaft polymer extrusion.A microscopic examination of the distal and proximal markerbands identified no damage as well as the bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.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 table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this product investigation is assigned the most probable cause classification of unintended use error caused or contributed to event.This code was selected as the most probable complaint cause based on the information available.Analysis of the returned device confirmed stent dislodgement.The stent was not crimped onto the balloon or returned for analysis.Based on the event description it is likely that an excessive force was applied to the device while removing the stent protector.Instructions for use (ifu) states to gently remove the stent protector.The unreported hypotube kink most likely occurred as a result of an unintentional use error and likely occurred during repackaging for return.

• 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: 24473955
• Report Number: 2124215-2026-11146
• Device Sequence Number: 21363870
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: (01)08714729980971(17)270129(10)35851368
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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
• Report Date (Section B): 04/01/2026

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: H7493941820300
• Device Catalogue Number: H7493941820300
• Device Lot Number: 0035851368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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