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

Model Number	H7493941812350
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A 3.50 x 12 mm synergy xd drug-eluting stent was advanced to the lesion site for treatment.The stent was initially advanced and then removed intact.Upon re-advancement, the stent failed to inflate.During the second removal, the stent exited the body while still on the guidewire and broke at the stent junction.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status and the additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status and the additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a shaft break occurred.A 3.50 x 12 mm synergy xd drug-eluting stent was advanced to the lesion site for treatment.The stent was initially advanced and then removed intact.Upon re-advancement, the stent failed to inflate.During the second removal, the stent exited the body while still on the guidewire and broke at the stent junction.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that a shaft break occurred.A 3.50 x 12 mm synergy xd drug-eluting stent was advanced to the lesion site for treatment.The stent was initially advanced and then removed intact.Upon re-advancement, the stent failed to inflate.During the second removal, the stent exited the body while still on the guidewire and broke at the stent junction.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status and the additional details regarding the reported event, but further information was unable to be obtained.The device was returned for evaluation.Visual and tactile inspection revealed multiple kinks along the hypotube shaft.A midshaft break was identified, located from the distal tip.Additionally, breaks were noted in the laser-cut sections from the strain relief.Microscopic analysis showed lifting of the stent struts in the distal section of the stent.The distal stent struts appeared slightly lifted and had shifted over the distal marker band.The balloon cones were examined and found to be intact, with no anomalies noted.The balloon wings were tightly wrapped and evenly folded, indicating they had not been subjected to positive pressure.The bumper tip showed no signs of damage.Functional testing was performed.Due to the midshaft break, a leak was observed at the break site.An inflation aid was attached to the distal end of the midshaft, and the balloon was successfully inflated to its rated burst pressure (rbp) of 16 atmospheres.The balloon inflated and the stent deployed without issue.No additional device anomalies were identified during the returned product analysis.

• 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: 22543404
• Report Number: 2124215-2025-47907
• Device Sequence Number: 17895905
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: (01)08714729981039(17)270224(10)36001246
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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: H7493941812350
• Device Catalogue Number: H7493941812350
• Device Lot Number: 0036001246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 10/09/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/02/2025; 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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