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

Model Number	H7493941838300
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact event date was not provided.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 removal difficulty occurred.The target lesion was located in a coronary artery.A 3.00 x 38mm synergy xd drug-eluting stent was advanced for treatment.However, it was noted that the stent catheter broke at the hub while removing it from the patient.The balloon was fully deflated prior to removal and was removed in one piece.The procedure was completed with the original device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.00 x 38mm stent delivery system (sds) was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break at the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section identified no issues.A microscopic examination of the stent profile showed no sign of damage, stretching or lifting of the stent struts.The balloon material was reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed signs of damage.B3: date of event: used first date of the month since exact event date was not provided.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 removal difficulty occurred.The target lesion was located in a coronary artery.A 3.00 x 38mm synergy xd drug-eluting stent was advanced for treatment.However, it was noted that the stent catheter broke at the hub while removing it from the patient.The balloon was fully deflated prior to removal and was removed in one piece.The procedure was completed with the original device.There were no patient complications reported.

• 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: 22333409
• Report Number: 2124215-2025-41200
• Device Sequence Number: 13059134
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: (01)08714729981015(17)261216(10)35553418
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 09/05/2025

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: H7493941838300
• Device Catalogue Number: H7493941838300
• Device Lot Number: 0035553418
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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