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

Model Number	H7493941828400
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent damage and dislodgement occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 4.00 x 28mm synergy xd drug-eluing stent was advanced for treatment using a 6f non-boston scientific extension guide catheter.However, upon entry into the vessel, the guide and the extension guide catheter backed out of the artery with the stent remaining at the ostium.While attempting to reseat the guide and extension guide catheter, the device sheared the stent off of the balloon requiring a vascular surgeon to snare it.The detached portion was removed and the procedure was completed with a 4.0x32 synergy stent.No patient complications were reported.
Event or Problem Description
It was reported that stent fracture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 4.00 x 28mm synergy xd drug-eluing stent was advanced for treatment using a 6f non-boston scientific extension guide catheter.However, upon entry into the vessel, the guide and the extension guide catheter backed out of the artery with the stent remaining at the ostium.While attempting to reseat the guide and extension guide catheter, the device sheared the stent off of the balloon requiring a vascular surgeon to snare it.The detached portion was removed and the procedure was completed with a 4.0x32 synergy stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not returned to the cis (complaint investigation site) for analysis however a photo was provided by the customer.The photo showed a vial containing a dislodged and damaged stent with struts stretched but not expanded.

• 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: 12593962
• Report Number: 2134265-2021-11914
• Device Sequence Number: 4289903
• Product Code: NIQ
• UDI-Device Identifier: 08714729981152
• UDI-Public: 08714729981152
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2022
• Device Model Number: H7493941828400
• Device Lot Number: 0026480264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female