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	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent moved on balloon occurred.The target lesion was located in the coronary artery.A 4.00 x 38mm synergy xd drug eluting stent (des) was advanced for dilatation.However, during the procedure, the stent partially shifted on the stent balloon prior to deployment.The device was removed from the patient's body successfully, and the procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that stent moved on balloon occurred.The target lesion was located in the coronary artery.A 4.00 x 38mm synergy xd drug eluting stent (des) was advanced for dilatation.However, during the procedure, the stent partially shifted on the stent balloon prior to deployment.The device was removed from the patient's body successfully, and the procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and tactile revealed the proximal stent struts were damaged, they were bunched and pulled distally towards the mid-section of the balloon.A stent strut was partially lifted at the distal section of the stent.The device was returned attached to a guide catheter.Balloon cones were reviewed and were not subjected to positive pressure.Microscopic examination of the stent revealed stent struts pulled distally and bunched at the mid-section of the stent.Balloon cones were reviewed and were not subjected to positive pressure.Stent positioning revealed no signs of movement at the distal end, stent struts did not pass the distal markerband.Bumper tip showed no signs of distal tip damage.Dimensional testing revealed that the undamaged crimped stent od (outer diameter) was measured by snap gauge and the result was 0.0485 inch which is within max crimped stent profile measurement.

• 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: 18770199
• Report Number: 2124215-2024-10380
• Device Sequence Number: 7701473
• Product Code: NIQ
• UDI-Device Identifier: 08714729981176
• UDI-Public: 08714729981176
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 03/27/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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