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

Lot Number	0030917759
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The 4.0 x 38 mm synergy xd drug-eluting stent was selected for use.Before entering the body, the stent came off the balloon.There were no patient complications.
Event or Problem Description
It was reported that stent dislodgement occurred.The 4.0 x 38 mm synergy xd drug-eluting stent was selected for use.Before entering the body, the stent came off the balloon.There were no patient complications.
Additional Manufacturer Narrative
The synergy xd mr us 4.00 x 38mm stent delivery system was returned for analysis.Visual inspection revealed no issues with the hyptube shaft, outer/mid shaft section, or the inner lumen of the device.Microscopic examination revealed no issues with the stent profile, balloon profile, stent positioning, or tip profile.The undamaged crimped stent od (outer diameter) was measured within max crimped stent profile measurement.No 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: 18000449
• Report Number: 2124215-2023-59268
• Device Sequence Number: 18051794
• Product Code: NIQ
• UDI-Device Identifier: 08714729981176
• UDI-Public: 08714729981176
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 01/24/2024

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: 01/15/2025
• Device Lot Number: 0030917759
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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
• Patient Sex: Unknown