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

Model Number	H7493941832450
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was 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 a shaft break occurred requiring additional intervention.A 4.50 x 32 mm synergy xd drug-eluting stent was advanced for treatment.During the procedure, the stent balloon failed to inflate.While attempting to remove the device, the physician broke the shaft.The remaining components of the shaft and balloon were successfully retrieved from the patient body using a snare.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.The device was returned for analysis.A visual and tactile examination of the hypotube shaft revealed no abnormalities.However, inspection of the outer and inner lumens, as well as the mid-shaft section, identified a break at the guidewire exchange port.Additionally, multiple polymer extrusion kinks were observed.Microscopic analysis of the balloon material showed no pinholes or tears.The balloon was returned in a deflated state and contained residual blood.The bumper tip exhibited signs of damage.Dimensional testing confirmed that the device was returned without the stent attached.The outer diameter (od) of the stent at the time of manufacturing was within the specified maximum crimped stent profile.Due to the condition of the returned device, a leakage test could not be performed.No additional device issues were identified during the returned product analysis.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 a shaft break occurred requiring additional intervention.A 4.50 x 32 mm synergy xd drug-eluting stent was advanced for treatment.During the procedure, the stent balloon failed to inflate.While attempting to remove the device, the physician broke the shaft.The remaining components of the shaft and balloon were successfully retrieved from the patients body using a snare.No patient complications were reported as a result of this event.

• 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: 21952957
• Report Number: 2124215-2025-26844
• Device Sequence Number: 15653532
• Product Code: NIQ
• UDI-Device Identifier: 08714729981237
• UDI-Public: (01)08714729981237(17)261001(10)35076559
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 06/18/2025

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 Expiration Date: 10/01/2026
• Device Model Number: H7493941832450
• Device Catalogue Number: H7493941832450
• Device Lot Number: 0035076559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown