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

Model Number	H7493941824250
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a coronary artery.A 2.50 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, while crossing the lesion, it was noticed that the stent twisted or crushed inside the artery.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 2.50 x 24mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts on the proximal end were lifted from the crimped profile.The undamaged stent outer diameter was measured and the result is within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a coronary artery.A 2.50 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, while crossing the lesion, it was noticed that the stent twisted or crushed inside the artery.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the stent strut was damaged and it was removed through the guide catheter.

• 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: 12310866
• Report Number: 2134265-2021-10320
• Device Sequence Number: 3682343
• Product Code: NIQ
• UDI-Device Identifier: 08714729980827
• UDI-Public: 08714729980827
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 11/02/2022
• Device Model Number: H7493941824250
• Device Lot Number: 0026344299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1