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

Lot Number	0031444705
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.A 5.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device, the stent detached from the balloon inside the patient.The device was removed successfully and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A 5.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device, the stent detached from the balloon inside the patient.The device was removed successfully and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 5.00 x 24mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.No issues identified with the hypotube shaft.The polymer extrusion was stretched near the port exchange and was broken, 55.5cm from the tip of the device.The guidewire, used by the physician, was received loaded through the inner /guidewire lumen.However, due to the stretching and bunching of the extrusion, the extrusion was stretched down onto the guidewire, preventing the removal of the wire from the lumen.The stent was not attached or returned.Although the balloon had stent crimp markings, it seemed the balloon was subjected to positive pressure.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.

• 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: 17958069
• Report Number: 2124215-2023-54510
• Device Sequence Number: 15212693
• Product Code: NIQ
• UDI-Device Identifier: 08714729981275
• UDI-Public: 08714729981275
• Combination Product (Y/N): Y
• Initial Reporter State: AK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 04/10/2025
• Device Lot Number: 0031444705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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