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

Lot Number	0031708795
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent moved on the balloon occurred.A 2.50 x 48mm synergy xd drug-eluting stent was selected for used.During preparation, it was opened, and when the stent was removed from the hoop, the stylet got caught, along with the stent strut, as it pulled or stretched the stent away from the balloon.The attached media also indicated that the stent was stretched, lifted, and moved from the balloon while inside the pouch.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy xd mr us 2.50 x 48mm stent delivery system (sds) was returned for analysis.A visual, tactile, and microscopic analysis of stent profile revealed the entire stent struts were stretched and damaged.Stent struts were pulled distally over the balloon cone and bumper tip.Balloon cones were reviewed and were not subjected to positive pressure.Visual and tactile inspection of the hypotube revealed multiple kinks were identified along the hypotube shaft.Shaft polymer extrusion revealed no kinks or damages.Microscopic analysis of the stent struts were pulled distally over balloon cone and tip of the device.Bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that the stent moved on the balloon occurred.A 2.50 x 48mm synergy xd drug-eluting stent was selected for used.During preparation, it was opened, and when the stent was removed from the hoop, the stylet got caught, along with the stent strut, as it pulled or stretched the stent away from the balloon.The attached media also indicated that the stent was stretched, lifted, and moved from the balloon while inside the pouch.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: 19406804
• Report Number: 2124215-2024-30488
• Device Sequence Number: 12456577
• Product Code: NIQ
• UDI-Device Identifier: 08714729985204
• UDI-Public: 08714729985204
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• 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): 07/03/2024

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: 05/15/2025
• Device Lot Number: 0031708795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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