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

Model Number	H7493941832250
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that moved on balloon occurred.A 2.50 x 32mm synergy xd drug eluting stent was selected for use.During preparation, it was noticed that the stent was partially detached from the balloon.The device was not used and the procedure was completed with a different device.There were no patient complication reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy xd mr us 2.50 x 32mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts from the mid to distal region were stretched and pulled over the distal tip.The undamaged stent outer diameter was measured using snap gauge and the result was 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 no issues.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.No other issues were identified during analysis.
Event or Problem Description
It was reported that moved on balloon occurred.A 2.50 x 32mm synergy xd drug eluting stent was selected for use.During preparation, it was noticed that the stent was partially detached from the balloon.The device was not used and the procedure was completed with a different device.There were no patient complication 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13366691
• Report Number: 2134265-2022-00754
• Device Sequence Number: 3952655
• Product Code: NIQ
• UDI-Device Identifier: 08714729980841
• UDI-Public: 08714729980841
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 03/04/2022

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: 09/20/2023
• Device Model Number: H7493941832250
• Device Lot Number: 0028129496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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: Male