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

Model Number	H7493941828250
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 2.50 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during removal, the stent was damaged.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
B5.Describe event or problem updated.E1.Initial reporter title and initial reporter last name updated.E3.Occupation updated.H6.Device code difficult to advance (a150205) added.
Event or Problem Description
It was reported that stent damage occurred.A 2.50 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during removal, the stent was damaged.The procedure was completed with a different device.There were no patient complications reported.It was further reported that there was resistance felt during insertion on which the stent strut was noted to be damaged, and the device was removed completely.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12510680
• Report Number: 2134265-2021-11925
• Device Sequence Number: 3398153
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: 08714729980834
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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: 11/18/2022
• Device Model Number: H7493941828250
• Device Lot Number: 0026429956
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1