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

Model Number	H7493941820250
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the non-calcified and non-tortuous saphenous vein graft to the obtuse marginal branch.A 2.50 x 20mm synergy xd stent was advanced to treat the lesion.However, during advancing, the shaft snapped in half just between the mid and distal portion.The device was removed and the procedure was completed with another 2.50 x 20 mm synergy stent.No patient complications were reported.
Additional Manufacturer Narrative
Updated: b5.Describe event or problem and d.Concomitant product/therapy.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the non-calcified and non tortuous saphenous vein graft (svg) to obtuse marginal (om) branch.A 2.50 x 20mm synergy xd stent was advanced to treat the lesion.However, the mid and distal shafts snapped with very little forward pressure.The physician was not pushing in to a barrier when the system snapped.The device was pulled out and the procedure was completed with another 2.50 x 20 mm synergy stent.No patient complications were reported.It was further reported that the valve was fully opened to allow easy passage of the device and there was no resistance encountered at any stage.The shaft snapped before any kind of attempt to straighten a kinked/bent shaft were identified.

• 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: 11216334
• Report Number: 2134265-2021-00254
• Device Sequence Number: 3795427
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: 08714729980810
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: 09/07/2022
• Device Model Number: H7493941820250
• Device Lot Number: 0026022859
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE EXTENSIO: 6 GUIDEZILLA CATHETER