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

Model Number	H7493941848300
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	04/11/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that deflation failure occurred, resulting in patient death.The target lesion was located in the proximal left anterior descending artery (lad).A 3.00 x 48mm synergy xd drug-eluting stent was advanced for treatment and placed in the proximal lad.However, the device would not deflate.Re-inflation attempts were made followed by deflation attempts, and approximately 30 seconds to one minute of wait time before attempting to remove the device.However, patient experienced chest pain and all equipment was removed.The patient was stable post procedure with a non-boston scientific heart pump implanted.Unfortunately, patient died.It is unknown if the device or procedure were a cause or contribution to the patient death.
Additional Manufacturer Narrative
B2 date of death: either (b)(6) 2025 as it was reported the patient 'died over the weekend'.
Event or Problem Description
It was reported that deflation failure occurred, resulting in patient death.The target lesion was located in the proximal left anterior descending artery (lad).A 3.00 x 48mm synergy xd drug-eluting stent was advanced for treatment and placed in the proximal lad.However, the device would not deflate.Re-inflation attempts were made followed by deflation attempts, and approximately 30 seconds to one minute of wait time before attempting to remove the device.However, patient experienced chest pain and all equipment was removed.The patient was stable post procedure with a non-boston scientific heart pump implanted.Unfortunately, patient died.It is unknown if the device or procedure were a cause or contribution to the patient death.It was further reported that the balloon deflation was approximately 20-30 seconds and in emdr tw# (b)(4) that the patient subsequently died of unknown cause sometime during the next two days.

• 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: 21972325
• Report Number: 2124215-2025-27611
• Device Sequence Number: 8160786
• Product Code: NIQ
• UDI-Device Identifier: 08714729985228
• UDI-Public: (01)08714729985228(17)260430(10)34015001
• Combination Product (Y/N): Y
• Initial Reporter State: NM
• 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): 05/29/2025

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 Expiration Date: 04/30/2026
• Device Model Number: H7493941848300
• Device Catalogue Number: H7493941848300
• Device Lot Number: 0034015001
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/29/2025
• Date Device Manufactured: 04/30/2024
• 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: Death
• Patient Age: 53 YR
• Patient Sex: Male