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

Model Number	H7493941838220
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that difficulty removal occurred.The patient underwent percutaneous coronary intervention (pci).The 90% stenosed target lesion was located in the severely tortuous and moderately calcified coronary artery.A 2.25 x 38mm synergy xd drug-eluting stent (des) was selected for treatment.The balloon was inflated at nominal pressure for 30 seconds to implant the stent.The balloon was then fully deflated for 10 seconds.However, the balloon became stuck and failed to retract.The device was eventually removed using a guide extension catheter, and the procedure was completed.There were no patient complications reported.It was noted that the catheter hypotube was kinked.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
H6 evaluation conclusion code clarification: per the instructions for use, the user is to allow a minimum of 30 seconds for the balloon to deflate, however it was reported that the balloon was only deflated for 10 seconds.
Event or Problem Description
It was reported that difficulty removal occurred.The patient underwent percutaneous coronary intervention (pci).The 90% stenosed target lesion was located in the severely tortuous and moderately calcified coronary artery.A 2.25 x 38mm synergy xd drug-eluting stent (des) was selected for treatment.The balloon was inflated at nominal pressure for 30 seconds to implant the stent.The balloon was then fully deflated for 10 seconds.However, the balloon became stuck and failed to retract.The device was eventually removed using a guide extension catheter, and the procedure was completed.There were no patient complications reported.It was noted that the catheter hypotube was kinked.

• 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: 22936220
• Report Number: 2124215-2025-59282
• Device Sequence Number: 9864980
• Product Code: NIQ
• UDI-Device Identifier: 08714729980773
• UDI-Public: (01)08714729980773
• 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): 01/08/2026

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 Model Number: H7493941838220
• Device Catalogue Number: H7493941838220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 01/08/2026
• 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