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

Lot Number	0032229571
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.A percutaneous coronary intervention was performed.A 3.00 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, the stent came off the balloon when attempting to deliver down the vessel.The detached component was snared and removed from the patient.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A percutaneous coronary intervention was performed.A 3.00 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, the stent came off the balloon when attempting to deliver down the vessel.The detached component was snared and removed from the patient.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the event was also submitted via medwatch (b)(4) and that the patient presented for a ventricular assistance device guided percutaneous coronary intervention.
Additional Manufacturer Narrative
The synergy xd mr us 3.00 x 28mm stent delivery system was returned for analysis.Visual and tactile inspection revealed no issues with the hypotube, and that the entire stent was found stretched and damaged and not crimped onto the balloon.Visual, tactile, and microscopic inspection revealed no issues with the outer/mid-shaft sections or the inner lumen of the device.Microscopic inspection showed the balloon cones had been subjected to positive pressure and that there was contrast inside the balloon material.The bumper tip showed no signs of damage.
Event or Problem Description
It was reported that stent dislodgement occurred.A percutaneous coronary intervention was performed.A 3.00 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, the stent came off the balloon when attempting to deliver down the vessel.The detached component was snared and removed from the patient.The procedure was completed with another of the same device.There was no patient complications reported.It was further reported that the event was also submitted via medwatch (b)(4) and that the patient presented for a ventricular assistance device guided percutaneous coronary intervention.

• 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: 19829629
• Report Number: 2124215-2024-46114
• Device Sequence Number: 12617653
• Product Code: NIQ
• UDI-Device Identifier: 08714729980995
• UDI-Public: 08714729980995
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2025
• Device Lot Number: 0032229571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 08/08/2024; 10/18/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/28/2024; 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male