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

Model Number	H7493941816350
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dislodgement occurred requiring additional intervention.The target lesion, which was 90% stenosed, was located in the moderately tortuous and severely calcified left circumflex artery.A 3.50 x 16mm synergy xd drug-eluting stent was selected for treatment.A non-boston scientific 6f guide catheter and a non-boston scientific 0.014-inch guidewire were also used.Two attempts were made to deliver the stent into the circumflex artery; however, the presence of moderate tortuosity, severe calcification, and a prior stent in the left main artery caused these attempts to fail.Upon removal of the stent inflation device, fluoroscopy revealed that the stent had inadvertently moved into the left main artery after detaching from the balloon before reaching the target lesion.This caused complications, as the stent was no longer in the intended position.The physician then attempted to pass a balloon through the undeployed stent, aiming to slightly inflate the balloon in order to engage the stent and pull it back into the guide catheter.However, this attempt was unsuccessful.Fluoroscopy showed that the stent had shortened and was now positioned in the distal left main and ostial lad.Due to the deformation of the stent and the inability to retrieve it, additional balloons were used to crush the stent against the vessel wall, ensuring continued blood flow.The procedure was aborted, and the patient fully recovered.

• 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: 20709383
• Report Number: 2124215-2024-70663
• Device Sequence Number: 8101068
• Product Code: NIQ
• UDI-Device Identifier: 08714729981046
• UDI-Public: 08714729981046
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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): 11/18/2024

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: 03/19/2026
• Device Model Number: H7493941816350
• Device Catalogue Number: H7493941816350
• Device Lot Number: 0033729426
• 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: 10/22/2024
• Initial Report FDA Received Date: 11/18/2024
• Date Device Manufactured: 03/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 6F.; GUIDEWIRE USED: 0.014-INCH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown