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

Model Number	H7493941824400
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A saphenous vein graft (svg) procedure was performed on a 60 to 70% stenosed target lesion, located in the mildly tortuous distal right coronary artery (rca).A 4.00 x 24mm synergy xd was used for treatment.It was noted that a non boston scientific embolic protection wire was not closed into the sheath prior to retraction.The non boston scientific filter basket caught onto the synergy xd stent struts, which deformed and damaged the stent.An attempt to rewire through the stent was performed, but was unsuccessful.The procedure was completed and the patient had good flow.No patient complications resulted in relation to this event and the patient was reported to be stable upon completion of the case.

• 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: 10919678
• Report Number: 2134265-2020-16344
• Device Sequence Number: 11379029
• Product Code: NIQ
• UDI-Device Identifier: 08714729981145
• UDI-Public: 08714729981145
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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: 06/29/2022
• Device Model Number: H7493941824400
• Device Lot Number: 0025687931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1