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

Model Number	H7493941848350
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The patient underwent percutaneous coronary intervention (pci) for a target lesion located in the coronary artery.Initially, a shockwave balloon was advanced but failed to cross the lesion.Subsequently, a 3.0mm emerge balloon catheter was successfully advanced and inflated with minimal waste.A 3.50 x 48mm synergy xd drug-eluting stent (des) was then selected for treatment, but it also failed to cross.However, during removal of the des system, a strut became stuck and began to come off of the distal end of the catheter.After additional attempts to remove the des system, the shaft broke.A snare was then used in an unsuccessful attempt to remove the device fragment.The patient underwent coronary artery bypass graft (cabg) surgery, but unfortunately, the patient died.
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.

• 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: 22987140
• Report Number: 2124215-2025-61159
• Device Sequence Number: 18372210
• Product Code: NIQ
• UDI-Device Identifier: 08714729985235
• UDI-Public: (01)08714729985235(17)270217(10)35970471
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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
• Report Date (Section B): 09/05/2025

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: H7493941848350
• Device Catalogue Number: H7493941848350
• Device Lot Number: 0035970471
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 02/17/2025
• 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; Death
• Patient Sex: Unknown