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

Lot Number	0033535592
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was difficulty in removing the stent and a shaft break occurred, necessitating additional intervention.The target lesion was located in the mildly tortuous and moderately calcified vein graft.Pre-dilation was performed with a non-boston scientific balloon.During the procedure, a 3.50 x 48mm synergy xd drug-eluting stent was advanced for treatment; however, when the stent delivery system was deflated, difficulty was encountered in removing the stent.Subsequently, during attempts to pull out the stent, the shaft was broken, leaving a portion of the stent inside the patient's body and the patient underwent coronary artery bypass grafting.A snare was attempted, and the device was successfully removed.The procedure was completed, and the patient remained stable 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: 19556771
• Report Number: 2124215-2024-36852
• Device Sequence Number: 6806413
• Product Code: NIQ
• UDI-Device Identifier: 08714729985235
• UDI-Public: 08714729985235
• 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): 06/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2026
• Device Lot Number: 0033535592
• 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: 05/28/2024
• Initial Report FDA Received Date: 06/18/2024
• Date Device Manufactured: 02/20/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown