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

Model Number	H7493941832250
Medical Device Problem Codes	Failure to Advance (2524); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation issue occurred.The patient presented with coronary artery disease and underwent percutaneous transluminal coronary angioplasty.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified vessel.A 2.50 x 32mm synergy xd drug-eluting stent was advanced for treatment; however, the stent had difficulty to track the lesion and deflation issue was also noted.The procedure was completed with another of the same device.No complications were reported, and the patient condition was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 2.50 x 32mm was returned for analysis.Visual, tactile, microscopic analysis and functional testing was performed on the device.A visual inspection of the hypotube shaft identified no issues.A visual inspection of the outer and inner lumen and tactile examination of the mid-shaft section found no issues.A microscopic examination of the stent showed no sign of damage, stretching or lifting of the stent struts.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A microscopic analysis of the bumper tip showed no signs of distal tip damage.Functional testing was performed by attaching the device to an inflation unit and the balloon was inflated to the rated burst pressure.The device held pressure, and the stent deployed without issues.
Event or Problem Description
It was reported that deflation issue occurred.The patient presented with coronary artery disease and underwent percutaneous transluminal coronary angioplasty.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified vessel.A 2.50 x 32mm synergy xd drug-eluting stent was advanced for treatment; however, the stent had difficulty to track the lesion and deflation issue was also noted.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.

• 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: 21417348
• Report Number: 2124215-2025-09140
• Device Sequence Number: 9199219
• Product Code: NIQ
• UDI-Device Identifier: 08714729980841
• UDI-Public: (01)08714729980841(17)250410(10)31453255
• Combination Product (Y/N): Y
• 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): 04/29/2025

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: 04/10/2025
• Device Model Number: H7493941832250
• Device Catalogue Number: H7493941832250
• Device Lot Number: 0031453255
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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