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

Lot Number	0031015131
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the synergy xd mr us 2.75 x 8mm stent delivery system catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.The device was received with the crimped stent pulled proximally off the balloon and was positioned on the distal extrusion.Examination of the hypotube identified a severe kink in the laser cut section.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.The stent was returned detached from the balloon and there was evidence of stent deformation.The stent appeared compressed in its mid-section.Bumper tip showed no signs of distal tip damage.Balloon cones were reviewed, and no issues were noted.There was clear evidence of stent crimp marks on the balloon.The balloon did not appear to have been subjected to any positive pressures.No other issues were identified with the device.
Event or Problem Description
Reportable based on device analysis completed on 08nov2024.A 2.75 x 8mm synergy xd drug-eluting stent was returned with no reported allegations.However, investigation result revealed a stent detach.

• 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: 20798299
• Report Number: 2124215-2024-72830
• Device Sequence Number: 7809754
• Product Code: NIQ
• UDI-Device Identifier: 08714729980865
• UDI-Public: 08714729980865
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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: 01/23/2025
• Device Lot Number: 0031015131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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