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

Model Number	H7493941828300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent movement from the balloon occurred.A 3.00 x 28mm synergy xd balloon expandable stent was selected for treatment.The synergy xd advanced through the copilot and a 6f guidezilla guide extension catheter.The synergy xd balloon was inflated within the vessel and removed.After removal, it was observed that the synergy xd stent was on the proximal part of the balloon.A new stent and new guidezilla guide extension catheter was used to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that stent movement from the balloon occurred.A 3.00 x 28mm synergy xd balloon expandable stent was selected for treatment.The synergy xd advanced through the copilot and a 6f guidezilla guide extension catheter.The synergy xd balloon was inflated within the vessel and removed.After removal, it was observed that the synergy xd stent was on the proximal part of the balloon.A new stent and new guidezilla guide extension catheter was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the synergy xd mr us 3.00 x 28mm stent delivery system (sds) was returned for analysis; an examination of the crimped stent via scope found evidence of damage.The entire stent was pulled proximally over proximal balloon cone and was positioned on the outer shaft.Stent struts were bunched.Due to the extent of the stent damage on the balloon, it was not possible to perform a measurement of the stent outer diameter.As a result, the stent crimp data (ref.Crimp data attached) was reviewed and it was noted that the maximum stent crimp profile was 0.0412 inch, taken during the manufacture of the batch.This value is within maximum crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon had been inflated.A visual and microscopic examination of the bumper tip no issues.A visual and tactile examination of the hypotube shaft found no kinks or damages.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.No other issues were identified during the product analysis.

• 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: 15951571
• Report Number: 2124215-2022-51818
• Device Sequence Number: 17977068
• Product Code: NIQ
• UDI-Device Identifier: 08714729980995
• UDI-Public: 08714729980995
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 01/30/2023

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: 02/15/2024
• Device Model Number: H7493941828300
• Device Lot Number: 0028915062
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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