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

Model Number	H7493941820400
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent moved on balloon.The 98-99% stenosed target lesion was located in the mildly tortuous and moderately calcified saphenous vein graft (svg) to obtuse marginal artery.There was no pre-dilation performed prior to advancement of a 4.00 x 20mm synergy xd drug-eluting stent.However, the stent would not cross the lesion and when the device was pulled back to the proximal svg, it was noticed that the stent moved on the balloon.An attempt to remove the stent was made, but the stent could not be removed without sliding off the balloon.The stent was deployed in the proximal svg to avoid losing it any further.After stenting, a balloon was advanced to dilate the lesion.An additional synergy xd was deployed successfully, and the procedure was completed.No patient complications were 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17043346
• Report Number: 2124215-2023-25052
• Device Sequence Number: 12053026
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• 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: 2023
• 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): 06/01/2023

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: 10/11/2024
• Device Model Number: H7493941820400
• Device Lot Number: 0030416735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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