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

Lot Number	0030775787
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shaft break occurred, requiring additional intervention.A 4.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device, the shaft became bent and fractured into two pieces.The device was removed by utilizing snares and other devices, and the procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that a shaft break occurred, requiring additional intervention.A 4.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device, the shaft became bent and fractured into two pieces.The device was removed by utilizing snares and other devices, and the procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the 100% stenosed target lesion was located in the moderately tortuous and moderately calcified circumflex artery.
Additional Manufacturer Narrative
Device evaluated by mfr: a synergy xd mr was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Visual and tactile examination identified a shaft break 54.5cm distal to the distal end of the strain relief, confirming the reported event.No other device issues were identified during returned product analysis.Based on the event description and analysis of the returned device, the reported shaft break was most likely due to patients challenging lesion.It is likely that an excessive force was used to maneuver through the moderately tortuous and moderately calcified circumflex artery which caused the shaft to bend and break.

• 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: 17957916
• Report Number: 2124215-2023-55424
• Device Sequence Number: 5295490
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: 12/18/2024
• Device Lot Number: 0030775787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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