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

Model Number	H7493941816350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Obstruction/Occlusion (2422); Reduced Blood Flow (4598)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced vessel occlusion, cardiac arrest, reduced blood flow, and dislodgement, all of which required additional intervention.The patient underwent a complex procedure on the proximal circumflex artery, which was 90% stenosed and had a 90-degree bend.It was located in a tortuous and severely calcified segment of the proximal circumflex artery.A 3.50 x 16mm synergy xd drug-eluting stent was advanced for treatment.Shockwave therapy was used to prepare the artery, and imaging was employed to assess the area.During the procedure, the stent became dislodged and stayed in the left main area of the artery.An attempt to remove it was made using a snare.However, the snaring resulted in cessation of flow to the left coronary system, leading to cardiac arrest.The patient was resuscitated, and flow was re-established.The decision was made to stent the area where the dislodged stent had ended up, restoring flow and stabilizing the patient.The patient remained on impella support post-procedure, successfully stented the problem area, and is expected to fully recover.

• 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: 21184447
• Report Number: 2124215-2024-84104
• Device Sequence Number: 19899211
• Product Code: NIQ
• UDI-Device Identifier: 08714729981046
• UDI-Public: 08714729981046
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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): 01/17/2025

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: 08/13/2026
• Device Model Number: H7493941816350
• Device Catalogue Number: H7493941816350
• Device Lot Number: 0034763571
• 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: 12/24/2024
• Initial Report FDA Received Date: 01/17/2025
• Date Device Manufactured: 08/13/2024
• 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