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

Lot Number	0030105343
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.During the procedure, a 2.25 x 12mm synergy xd drug-eluting stent was advanced for treatment but could not pass though the lesion.However, upon advancing the stent into the patient, it was noticed that the stent was broken.No patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.During the procedure, a 2.25 x 12mm synergy xd drug-eluting stent was advanced for treatment but could not pass though the lesion.However, upon advancing the stent into the patient, it was noticed that the stent was broken.No patient complications reported.It was further reported that the shaft near the hub broke, and the physician may have bent the device while advancing it into the guide catheter.

• 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: 17843192
• Report Number: 2124215-2023-52633
• Device Sequence Number: 12574612
• Product Code: NIQ
• UDI-Device Identifier: 08714729980711
• UDI-Public: 08714729980711
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 10/09/2023

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: 08/29/2024
• Device Lot Number: 0030105343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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