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

Model Number	H7493941812300
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 12mm synergy xd drug eluting stent was advanced for treatment but it failed to cross the lesion and it was also noted that the stent was damaged.The procedure was completed with another of same device.There were no patient complications reported.
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 12mm synergy xd drug eluting stent was advanced for treatment but it failed to cross the lesion.However, it was noted that the stent was damaged.The procedure was completed with another of same device.There were no patient complications reported.It was further reported that the target lesion was located in the heavily calcified left circumflex artery.There were no adverse patient events and no failure 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13840899
• Report Number: 2134265-2022-03190
• Device Sequence Number: 14635314
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: 08714729980957
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 04/12/2022

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: 10/18/2023
• Device Model Number: H7493941812300
• Device Lot Number: 0028289610
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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