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

Model Number	H7493941812300
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
Type of Reportable Event	Serious Injury
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 dislodged occurred.A 3.00 x 12mm synergy? xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion, and the stent came off the balloon.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.
Event or Problem Description
It was reported that stent dislodged occurred.A 3.00 x 12mm synergy? xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion, and the stent came off the balloon.No patient complications were reported.It was further reported that the target lesion was located in the distal left main and circumflex artery.The stent separated from the balloon without inflation, and another balloon was advanced to expand the dislodged stent.
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 implanted and will not be returned; therefore, a technical analysis could not be performed.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.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 event description and lack of information provided.It was reported that the stent separated from the balloon without inflation, and another balloon was advanced to expand the dislodged stent.A good faith effort was conducted to obtain additional clarification from the customer/account; however, no further information was available.The complaint device was not returned for analysis therefore reported allegation could not be confirmed.Based on the medical review task conducted for this complaint, the reported clinical event is anticipated per the instructions for use (ifu).As a result, the investigation is limited, and no definitive conclusions can be drawn based on the incomplete and unclear data provided.
Event or Problem Description
It was reported that stent dislodged occurred.A 3.00 x 12mm synergy? xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion, and the stent came off the balloon.No patient complications were reported.It was further reported that the target lesion was located in the distal left main and circumflex artery.The stent separated from the balloon without inflation, and another balloon was advanced to expand the dislodged stent.

• 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: 24306425
• Report Number: 2124215-2026-07465
• Device Sequence Number: 14738093
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: (01)08714729980957(17)270827(10)37395801
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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: H7493941812300
• Device Catalogue Number: H7493941812300
• Device Lot Number: 0037395801
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 04/08/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/03/2026; 04/20/2026
• Date Device Manufactured: 08/27/2025
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White