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

Lot Number	0031486981
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.A 2.75 x 8mm synergy xd drug eluting-stent and luge guidewire were used during procedure.The guidewire became stuck on the stent and the guidewire sheared off in the stent.Another stent was placed to trap the guidewire in the vessel wall.The patient died.
Event or Problem Description
It was reported that the patient died.A 2.75 x 8mm synergy xd drug eluting-stent and luge guidewire were used during procedure.The guidewire became stuck on the stent and the guidewire sheared off in the stent.Another stent was placed to trap the guidewire in the vessel wall.The patient died.It was further reported that the patient was critically ill prior to and after the procedure.The target vessel was moderate to severely calcified and angulated.It was noted that when the second stent was deployed across the struts of the first stent, the distal end of the wire sheared off from the main shaft as withdrawing the proximal wire was without any resistance.In the physician operator's opinion, the device did not cause or contribute to the patient death.

• 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: 18796502
• Report Number: 2124215-2024-11671
• Device Sequence Number: 7248006
• Product Code: NIQ
• UDI-Device Identifier: 08714729980865
• UDI-Public: 08714729980865
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2025
• Device Lot Number: 0031486981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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: Death
• Patient Age: 76 YR
• Patient Sex: Unknown