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

Model Number	H7493941816250
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.After a guidezilla was advanced for support, a 2.50 x 16mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent dislodged inside the balloon delivery system and was remained inside the guidezilla on the stent delivery system shaft.The physician removed the guidewire, guidezilla and the device with the stent delivery system.The procedure was completed with another of the same device and no harm was done to the patient.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient was being treated for coronary artery disease and underwent percutaneous coronary intervention.During the intervention a guidezilla was used for support.When the physician advanced the 2.50 x 16mm synergy xd drug-eluting stent, it dislodged inside the balloon delivery system and the stent remained inside the guidezilla on the stent delivery system shaft.The physician removed the guidewire, guidezilla and synergy xd stent with stent delivery system.The procedure was completed with another of same device and no patient harm resulted in relation to this event.It was further reported that the target lesion was located in the heart.The stent was stuck inside the guidezilla guide extension catheter.No damage was noted on the guidezilla.The devices were removed all together as one unit and replaced with new equipment to complete the percutaneous coronary intervention (pci) without harm to the patient.
Additional Manufacturer Narrative
B5 - describe event or problem and h6.Device code: updated.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the synergy xd stent delivery system was returned for analysis inside a guide catheter loaded onto a guidewire, the following attributes were examined.The stent was not crimped in place between the two marker bands, it was instead found located down below the guidewire port in a damaged crushed state.Device to device interaction test: guidewire was removed without issue.The device could not be removed from the guide catheter without further damage to the device.No other issues were identified during analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient was being treated for coronary artery disease and underwent percutaneous coronary intervention.During the intervention a guidezilla was used for support.When the physician advanced the 2.50 x 16mm synergy xd drug-eluting stent, it dislodged inside the balloon delivery system and the stent remained inside the guidezilla on the stent delivery system shaft.The physician removed the guidewire, guidezilla and synergy xd stent with stent delivery system.The procedure was completed with another of same device and no patient harm resulted in relation to this event.It was further reported that the target lesion was located in the heart.The stent was stuck inside the guidezilla with no damage noted with the device.The devices were removed all together as one unit and replaced with new equipment to complete the percutaneous coronary intervention (pci) without harm to the patient.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16455437
• Report Number: 2124215-2023-09006
• Device Sequence Number: 5844708
• Product Code: NIQ
• UDI-Device Identifier: 08714729980803
• UDI-Public: 08714729980803
• Combination Product (Y/N): Y
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2023

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: 10/09/2024
• Device Model Number: H7493941816250
• Device Lot Number: 0030372910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/06/2023; 03/30/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/15/2023; 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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
• Patient Sex: Unknown