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

Model Number	H7493941848400
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a coronary artery.While advancing a 4.00 x 48mm synergy xd drug-eluting stent through a 6f guidezilla guide extension catheter, the stent came off of the balloon.The guidezilla was then removed, and the stent came out with it.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a coronary artery.While advancing a 4.00 x 48mm synergy xd drug-eluting stent through a 6f guidezilla guide extension catheter, the stent came off of the balloon.The guidezilla was then removed, and the stent came out with it.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that a resistance was felt when the stent was advanced into the guidezilla at the transition point.
Additional Manufacturer Narrative
H6 device code: corrected.

• 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: 20719511
• Report Number: 2124215-2024-70430
• Device Sequence Number: 12401045
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: 08714729985242
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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,Followup
• Report Date (Section B): 12/03/2024

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: 04/15/2026
• Device Model Number: H7493941848400
• Device Catalogue Number: H7493941848400
• Device Lot Number: 0033881802
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/03/2024
• Date Device Manufactured: 04/15/2024
• 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
• Patient Sex: Unknown