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

Model Number	H7493941820250
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: there was no date provided.
Event or Problem Description
It was reported that stent damage occurred.A 2.50 x 20mm synergy xd drug eluting stent was selected for use.However, the device would not load onto the wire and the stent was damaged.No patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.A 2.50 x 20mm synergy xd drug eluting stent was selected for use.However, the device would not load onto the wire and the stent was damaged.No patient complications were reported.It was further reported that it was the stent strut itself that got lifted.The procedure was completed with another of same device.

• 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: 11384810
• Report Number: 2134265-2021-02471
• Device Sequence Number: 17005205
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: 08714729980810
• Combination Product (Y/N): Y
• Initial Reporter State: WY
• 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): 03/15/2021

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: 12/14/2022
• Device Model Number: H7493941820250
• Device Lot Number: 0026563096
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1