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

Model Number	H7493941812400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 12mm synergy xd drug-eluting stent was selected for use.However, during preparation, it was noted that the shaft broke.The device was replaced, and a new stent was used to complete the procedure successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 12mm stent delivery system was returned for analysis.The device was returned without the stent detached and it was not possible to measure stent outer diameter due to its bunched and damaged state.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture is within max crimped stent profile measurement.The balloon cones were reviewed with crimp markings visible on the exposed balloon profile.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 12mm synergy xd drug-eluting stent was selected for use.However, during preparation, it was noted that the shaft broke.The device was replaced, and a new stent was used to complete the procedure successfully.No patient complications were reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16022015
• Report Number: 2124215-2022-53034
• Device Sequence Number: 6923013
• Product Code: NIQ
• UDI-Device Identifier: 08714729981114
• UDI-Public: 08714729981114
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 09/20/2023
• Device Model Number: H7493941812400
• Device Lot Number: 0028130805
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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