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

Model Number	H7493941820270
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Material Separation (1562); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The patient underwent percutaneous coronary intervention (pci).A 2.75 x 20mm synergy xd drug-eluting stent was advanced for treatment but failed to cross the lesion.It was noted that the stent balloon did not expand, and the stent came off the balloon inside the guide catheter.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter phone number: (b)(6).H6: device codes - corrected from a051201 device dislodged or dislocated to a0401 break.H6: device codes- removed a0413 material separation and a1406 inflation problem.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient underwent percutaneous coronary intervention (pci).A 2.75 x 20mm synergy xd was advanced but failed to cross lesion.However, the balloon did not expand; the stent came off the balloon and was dislodged in the guider.No patient complications were reported.It was further reported that the stent came off the delivery system inside the guide catheter prior to deployment.The balloon and stent broke off from the distal shaft and were detached from the delivery system.The device was removed as a whole unit and the procedure was completed with a different device.
Additional Manufacturer Narrative
B5: describe event or problem updated.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient underwent percutaneous coronary intervention (pci).A 2.75 x 20mm synergy xd was advanced but failed to cross lesion.However, the balloon did not expand; the stent came off the balloon and was dislodged in the guider.No patient complications were reported.It was further reported that the balloon and stent came off the delivery system inside the guide catheter.The device was removed with the guide catheter as a whole unit and the procedure was completed with a different device.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16756088
• Report Number: 2124215-2023-16742
• Device Sequence Number: 3264958
• Product Code: NIQ
• UDI-Device Identifier: 08714729980896
• UDI-Public: 08714729980896
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 05/08/2023

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: 09/18/2024
• Device Model Number: H7493941820270
• Device Lot Number: 0030258815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 04/17/2023; 05/05/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 04/21/2023; 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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