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

Model Number	H7493941820350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 3.50 x 20mm synergy xd drug-eluting stent (des) was deployed.During deployment, the balloon was initially inflated at low pressure; however, the balloon ruptured.A non-compliant balloon was then used to optimize the stent.The device was removed successfully with no fragments left in the patient.The procedure was completed using an alternate device.No patient complications were reported, and the patient made a full recovery.
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.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the stent was implanted and the stent delivery system will not be returned for analysis; 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 based on the event description.The product record review confirmed that this is not a new failure type and the risk is anticipated.There was no evidence of a manufacturing issue or design issue which could have caused the complaint.Based on this event review and details provided it was not possible to determine whether procedural technique, patient anatomy or another factor may have contributed to the reported damage.As a result, a definitive cause cannot be confirmed based on the available information.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.50 x 20mm synergy xd drug-eluting stent (des) was deployed.During deployment, the balloon was initially inflated at low pressure; however, the balloon ruptured.A non-compliant balloon was then used to optimize the stent.The device was removed successfully with no fragments left in the patient.The procedure was completed using an alternate device.No patient complications were reported, and the patient made a full recovery.

• 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: 24412736
• Report Number: 2124215-2026-09763
• Device Sequence Number: 12232224
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: (01)08714729981053(17)270304(10)36068842
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 04/26/2026

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: H7493941820350
• Device Catalogue Number: H7493941820350
• Device Lot Number: 0036068842
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/26/2026
• Date Device Manufactured: 03/04/2025
• 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