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

Model Number	H7493941848400
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderately to severely calcified right coronary artery.A 4.00 x 48 mm synergy xd drug-eluting stent was advanced for deployment.However, during initial inflation at 4 atmospheres for 1-2 seconds, the stent balloon ruptured.The device was removed successfully, and the procedure was completed using an alternate device.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 balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderately to severely calcified right coronary artery.A 4.00 x 48mm synergy xd drug-eluting stent was advanced for deployment.However, during initial inflation at 4 atmospheres for 1-2 seconds, the stent balloon ruptured.The device was removed successfully, and the procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Investigation results: device analysis findings: a partial synergy xd mr us 4.00 x 48mm was returned for analysis.A visual and tactile inspection identified a break in the hypotube shaft 67cm distal to the distal end of the strain relief, however the distal section of the break did not return for analysis.A microscopic examination of the hypotube shaft found no additional issues or damage.A microscopic examination of the manifold identified no issues.A leakage testing was not possible as the distal section of the device did not return for 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.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 information within the event and also considering the device analysis.This conclusion code is based on the available information and the review/testing conducted at boston scientific site.It was reported that during the initial inflation at 4 atmospheres for 1-2 seconds, the stent balloon ruptured.The device returned for analysis incomplete.The partial device returned with an unreported break in the hypotube shaft with only the proximal section returning for analysis.Without the stent balloon section of the device the reported rupture cannot be confirmed.It is most likely that the device break occurred post procedure when it was being repackaged for product return and the distal section was misplaced at this stage.

• 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: 23644975
• Report Number: 2124215-2025-86353
• Device Sequence Number: 9858991
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: (01)08714729985242(17)270122(10)35754423
• 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): 03/29/2026

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: H7493941848400
• Device Catalogue Number: H7493941848400
• Device Lot Number: 0035754423
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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