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

Model Number	H7493941816300
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 3.00 x 16mm synergy xd drug-eluting stent was loaded on a non-boston scientific guidewire but failed to track and ended up getting fused to the guidewire outside of the body.After an unsuccessful attempt to forcefully remove the device from the guidewire, the physician needed to cut the guidewire to get the device off.It was also noted that the stent became damaged.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the synergy xd mr us 3.00 x 16mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found that the stent was deformed and mangled on the balloon.As a result of the condition of the stent it was not possible to measure the stent outer diameter (od).As a result a review was performed into the stent crimp od at the time of production and was within maximum crimped stent profile measurement.It was not possible to examine the balloon due to the damaged stent on the balloon.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual and microscopic examination of the shaft polymer extrusion found to the extrusion to be bunched along its length.As a result of this damage it was not possible to pass a recommended 0.014 inch guidewire through the stretched and bunched lumen.
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 3.00 x 16mm synergy xd drug-eluting stent was loaded on a non-boston scientific guidewire but failed to track and ended up getting fused to the guidewire outside of the body.After an unsuccessful attempt to forcefully remove the device from the guidewire, the physician needed to cut the guidewire to get the device off.It was also noted that the stent became damaged.The procedure was completed with another of same device.No patient complications were reported.

• 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: 15824618
• Report Number: 2124215-2022-46280
• Device Sequence Number: 6143655
• Product Code: NIQ
• UDI-Device Identifier: 08714729980964
• UDI-Public: 08714729980964
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 01/03/2023

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: 08/22/2024
• Device Model Number: H7493941816300
• Device Lot Number: 0030046974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: BMW; GUIDEWIRE: BMW
• Patient Sex: Unknown