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

Model Number	H7493941828250
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy xd mr us 2.50 x 28mm stent delivery system (sds), catheter was returned for analysis.The following attributes were examined.Stent profile, a visual examination of the stent found issues.The entire stent was found to be damaged and moved distally along the balloon.Due to the level of damage, it was not possible to get a crimped stent od.A review of the manufacturing stent profile data was performed and the stent od was measured within max crimped stent profile measurement specification.Balloon profile: 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.The crimp marking s were visible on the balloon material.Tip profile: a visual and microscopic examination of the bumper tip showed no signs of distal tip damage.Hypotube profile: a visual and tactile examination of the hypotube identified multiple hypotube kinks.Shaft polymer extrusion profile: 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
Reportable based on device analysis completed on 22oct2021 it was reported that the device could not cross the lesion.A synergy xd mr us 2.50 x 28mm stent balloon expandable device could not cross the highly calcified artery.No patient complications were reported.However, device analysis revealed stent damage.

• 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: 12697849
• Report Number: 2134265-2021-13443
• Device Sequence Number: 19944671
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: 08714729980834
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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: 02/03/2023
• Device Model Number: H7493941828250
• Device Lot Number: 0026809070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR