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

Model Number	H7493941816250
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty removal occurred.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified middle of the circumflex artery.A 2.50 x 16mm synergy xd drug-eluting stent was advanced for treatment.After the stent balloon deployment at nominal pressure for 15 seconds, difficulty removal of the balloon was encountered upon pulling back.The guide was repeatedly sucked in for two minutes, and negative pressure was applied in an attempt to remove all air from the balloon.The device was removed in one piece and the procedure was completed with a different device without any patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device synergy xd mr us 2.50 x 16mm stent delivery system was returned to the complaint investigation site (cis) for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination identified multiple hypotube kinks along the length of the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.No stent was returned for analysis, consistent with the reported event of the stent being deployed without issue.Bumper tip showed no signs of distal tip damage.The device was attached to an encore inflation unit and the balloon was inflated successfully and without issue.A vacuum was applied, and the balloon deflated fully with no issues noted.The encore device was verified before use by using the druck gauge, inflation was to the rate burst pressure of 18 atmospheres (atm) as per instructions for use (ifu).No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that difficulty removal occurred.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified middle of the circumflex artery.A 2.50 x 16mm synergy xd drug-eluting stent was advanced for treatment.After the stent balloon deployment at nominal pressure for 15 seconds, difficulty removal of the balloon was encountered upon pulling back.The guide was repeatedly sucked in for two minutes, and negative pressure was applied in an attempt to remove all air from the balloon.The device was removed in one piece and the procedure was completed with a different device without any 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: 21721767
• Report Number: 2124215-2025-17881
• Device Sequence Number: 18539454
• Product Code: NIQ
• UDI-Device Identifier: 08714729980803
• UDI-Public: (01)08714729980803(17)260916(10)34953959
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 06/06/2025

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: 09/16/2026
• Device Model Number: H7493941816250
• Device Catalogue Number: H7493941816250
• Device Lot Number: 0034953959
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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