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

Lot Number	0032265944
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.The 99% stenosed target lesion was located in the non-tortuous and high-grade lesion of the proximal left anterior descending artery.A 2.50 x 16mm synergy xd drug-eluting stent was advanced; but failed to cross the lesion and thrombosis occurred.Multiple balloon inflations and an attempt to place the stent were performed.The patient was placed on an intra-aortic balloon pump to be safely transferred to another facility.The patient was in stable condition post procedure.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20523534
• Report Number: 2124215-2024-63710
• Device Sequence Number: 9171466
• Product Code: NIQ
• UDI-Device Identifier: 08714729980803
• UDI-Public: 08714729980803
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/24/2024

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: 08/13/2025
• Device Lot Number: 0032265944
• 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: 10/01/2024
• Initial Report FDA Received Date: 10/24/2024
• Date Device Manufactured: 08/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown