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	11/01/2025
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.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 dislodged requiring additional intervention.A 3.00 x 20mm synergy? xd drug-eluting stent was advanced for treatment.While crossing the lesion, the stent came off of the delivery system balloon.The physician opted to deploy an additional stent to pin the dislodged stent and complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodged requiring additional intervention.A 3.00 x 20mm synergy? xd drug-eluting stent was advanced for treatment.While crossing the lesion, the stent came off of the delivery system balloon.The physician opted to deploy an additional stent to pin the dislodged stent and complete the procedure.No patient complications were 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.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 drug-eluting stent was returned for analysis.A visual and tactile examination of the hypotube noted multiple hypotube kinks along the length of the hypotube shaft and the entire shaft polymer extrusion found no issues.And no stent was returned.A detailed microscopic examination of the balloon and tip found no issues.Evidence of crimp markings was present on the balloon body.A microscopic examination of the proximal and distal markerbands identified no damage.No other issues were noted during 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 cause not established.This code was selected as the most probable complaint cause based on the information available.The device was returned to the galway complaints investigation site with no stent attached and therefore the allegation can be confirmed.It is possible that an interaction occurred between the stent and the lesion's anatomical features and/or an interaction with other ancillary devices used during the procedure.However, based on the available information and condition of the returned device, a clear conclusion cannot be established.

• 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: 23842373
• Report Number: 2124215-2025-91786
• Device Sequence Number: 18523296
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: (01)08714729980971(17)270715(10)37053849
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 04/13/2026

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
• Device Model Number: H7493941820300
• Device Catalogue Number: H7493941820300
• Device Lot Number: 0037053849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown