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

Model Number	H7493941848400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right coronary artery.A 4.00 x 48mm synergy xd drug eluting stent was selected for use.However, when removing the stent out of the hoop, the stent appeared to be off the balloon.The device was not inserted into the body.The procedure was completed with a new 48mm synergy stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 48mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found evidence of stent damage with stent struts lifted and pulled over balloon and tip at distal section.The undamaged crimped stent outer diameter was measured by 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 tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right coronary artery.A 4.00 x 48mm synergy xd drug eluting stent was selected for use.However, when removing the stent out of the hoop, the stent appeared to be off the balloon.The device was not inserted into the body.The procedure was completed with a new 48mm synergy stent.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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16724097
• Report Number: 2124215-2023-15388
• Device Sequence Number: 7225837
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: 08714729985242
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 05/22/2023

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: 10/09/2024
• Device Model Number: H7493941848400
• Device Lot Number: 0030355448
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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