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

Lot Number	0031444705
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty and shaft break occurred.The target lesion was located in the non-tortuous and non-calcified left main coronary artery.A 5.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.The balloon was inflated to approximately 12 atm and the stent was implanted without difficulty.During removal and after balloon deflation, resistance was noticed when removing, and the balloon became lodged within the stent.At the second attempt, the stent balloon was successfully pulled into the guide catheter, but the stent delivery shaft fractured and broke apart near the monorail wire exit port within the guide catheter.The detached portion of the device was removed inside the guide catheter from the patient.It was noted that vacuum was applied and held during balloon withdrawal.Physical damage was observed post-procedure, and the balloon was deflated prior to removal.The procedure was completed with the original device.There were no patient complications reported.

• 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: 18773358
• Report Number: 2124215-2024-10377
• Device Sequence Number: 15388286
• Product Code: NIQ
• UDI-Device Identifier: 08714729981275
• UDI-Public: 08714729981275
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2025
• Device Lot Number: 0031444705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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
• Patient Age: 48 YR
• Patient Sex: Male