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

Model Number	H7493941808400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The 90% stenosed, target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 4.00 x 8mm synergy xd drug-eluting stent was advanced for treatment.Upon repositioning, the stent was dislodged.The stent was crushed to the side wall of the vessel and the procedure completed successfully with a 3.75x12 nc emerge balloon catheter.There were no patient complications.
Event or Problem Description
It was reported that stent dislodgement occurred.The 90% stenosed, target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 4.00 x 8mm synergy xd drug-eluting stent was advanced for treatment.Upon repositioning, the stent was dislodged.The stent was crushed to the side wall of the vessel and the procedure completed successfully with a 3.75x12 nc emerge balloon catheter.There were no patient complications.It was further reported that multiple attempts had been made to position the stent and that the stent was dislodged at the lesion site.Accidental pressure was not applied to the delivery system while positioning and repositioning at the lesion site and no resistance was felt while advancing the device in the guide catheter or over the wire.As per physician opinion, the cause of the reported event was the calcium.
Additional Manufacturer Narrative
An angiographic photo was provided by the site.However, due to the poor quality of the image it could not be determined with certainty if the image was showing a dislodged stent.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15229486
• Report Number: 2134265-2022-08520
• Device Sequence Number: 2109297
• Product Code: NIQ
• UDI-Device Identifier: 08714729981107
• UDI-Public: 08714729981107
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 09/26/2022

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: 09/29/2023
• Device Model Number: H7493941808400
• Device Lot Number: 0028174944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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 Sex: Unknown