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

Lot Number	0033940476
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 13feb2025.It was reported that inflation issue occurred.A 2.50 x 48mm synergy xd drug-eluting stent was advanced for treatment however, when the physician tried to deploy the stent, the stent would not inflate.The device was removed from the body with the stent still intact onto the balloon.Another stent was used to complete the procedure successfully.No patient complications were reported.However, returned device analysis revealed that outer lumen of shaft polymer extrusion had a tear.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 2.50 x 48mm was returned for analysis.Visual, tactile, microscopic and functional analysis was performed on the device.Multiple kinks were identified along the shaft polymer extrusion with a tear noted in the outer lumen, 38.1cm proximal from the bumper tip of the device.When attempting to inflate, the inflation liquid was seen coming from the tear in the outer lumen.No other device issues were identified during 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: 21560619
• Report Number: 2124215-2025-13388
• Device Sequence Number: 21232991
• Product Code: NIQ
• UDI-Device Identifier: 08714729985204
• UDI-Public: 08714729985204
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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 Expiration Date: 04/23/2026
• Device Lot Number: 0033940476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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