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

Lot Number	0033291989
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	07/18/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.During the procedure, a 2.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.Upon delivering the stent for implantation, the physician encountered resistance and the shaft was broken.The device was pulled manually and the patient was being treated, however; the patient died.

• 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: 20070979
• Report Number: 2124215-2024-52024
• Device Sequence Number: 3075900
• Product Code: NIQ
• UDI-Device Identifier: 08714729980797
• UDI-Public: 08714729980797
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2024

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: 01/09/2026
• Device Lot Number: 0033291989
• 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: 07/31/2024
• Initial Report FDA Received Date: 08/26/2024
• Date Device Manufactured: 01/10/2024
• 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; Death
• Patient Sex: Unknown