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

Model Number	H7493941828350
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break, balloon deflation failure, and removal difficulty occurred requiring additional intervention.The target lesion was located in the left anterior descending artery (lad).A 3.50 x 28 mm synergy xd drug-eluting stent was advanced to the lesion site with some resistance noted during insertion and advancement of the device.During balloon inflation for stent deployment, the catheter shaft broke in half within the patient's coronary artery.The balloon failed to deflate promptly, resulting in patient pain and discomfort.The physician was able to deflate the balloon eventually, but the broken catheter fragment could not be retrieved with a snare or a non-boston scientific guide catheter.The stent was implanted, however; the patient was referred for emergency coronary artery bypass graft (cabg) surgery.During the surgery, the retained catheter and balloon fragment was successfully removed.The patient was discharged and is expected to make a full recovery.
Event or Problem Description
It was reported that shaft break, balloon deflation failure, and removal difficulty occurred requiring additional intervention.The target lesion was located in the left anterior descending artery (lad).A 3.50 x 28 mm synergy xd drug-eluting stent was advanced to the lesion site with some resistance noted during insertion and advancement of the device.During balloon inflation for stent deployment, the catheter shaft broke in half within the patient's coronary artery.The balloon failed to deflate promptly, resulting in patient pain and discomfort.The physician was able to deflate the balloon eventually, but the broken catheter fragment could not be retrieved with a snare or a non-boston scientific guide catheter.The stent was implanted, however; the patient was referred for emergency coronary artery bypass graft (cabg) surgery.During the surgery, the retained catheter and balloon fragment was successfully removed.The patient was discharged and is expected to make a full recovery.

• 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: 22351516
• Report Number: 2124215-2025-39984
• Device Sequence Number: 8519862
• Product Code: NIQ
• UDI-Device Identifier: 08714729981077
• UDI-Public: (01)08714729981077(17)261021(10)35252070
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/05/2025

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 Model Number: H7493941828350
• Device Catalogue Number: H7493941828350
• Device Lot Number: 0035252070
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 10/21/2024
• 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 Age: 83 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White