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

Lot Number	0029596705
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 30-aug-2022.It was reported that device damage occurred.A 4.00 x 48mm synergy xd drug-eluting stent was selected for treatment, but the device was noted to be damaged.No patient complications were reported.However, returned device analysis revealed stent detachment.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 4.00 x 48mm stent delivery system (sds) was returned for analysis.Visual/tactile, microscopic and dimensional analyses were performed on the device.The stent was returned detached from the device.Damage along the entire length of the stent was noted with the stent struts pulled and stretched evidencing excessive tensile force applied to the stent.A stent od reading couldn't be obtained.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was 0.0484 inches which is within specification.Balloon cones were reviewed where it was subjected to positive pressure.No issues were identified with the hypotube shaft.No issues were identified with the outer/mid-shaft sections or the inner lumen of the device.Bumper tip showed no signs of distal tip damage.

• 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: 17811044
• Report Number: 2124215-2023-47998
• Device Sequence Number: 15249841
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: 08714729985242
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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
• Report Date (Section B): 09/25/2023

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: 06/06/2024
• Device Lot Number: 0029596705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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
• Patient Sex: Unknown