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

Lot Number	0033255335
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: use first date of the month since exact date of event was not provided.
Event or Problem Description
It was reported that the stent moved on the balloon.A 4.00 x 28mm synergy xd drug-eluting stent was selected for use.However, during preparation, it was noted the stent looked mangled and was partially off the shaft when it was removed from the hoop.The stent was put aside, and a replacement stent was used to complete the procedure successfully.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 28mm stent delivery system (sds) was returned for analysis.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.Examination of the crimped stent via scope found evidence of stent damage with the struts pulled from the mid-section towards the bumper distal tip.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The undamaged crimped stent outer diameter was measured by snap gauge and the result was within max crimped stent profile measurement.B3: date of event: use first date of the month since exact date of event was not provided.
Event or Problem Description
It was reported that the stent moved on the balloon.A 4.00 x 28mm synergy xd drug-eluting stent was selected for use.However, during preparation, it was noted the stent looked mangled and was partially off the shaft when it was removed from the hoop.The stent was put aside, and a replacement stent was used to complete the procedure successfully.There were no patient complications reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20358802
• Report Number: 2124215-2024-61493
• Device Sequence Number: 18164267
• Product Code: NIQ
• UDI-Device Identifier: 08714729981152
• UDI-Public: 08714729981152
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 01/14/2026
• Device Lot Number: 0033255335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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