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

Model Number	H7493941816300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the mildly tortuous and mildly calcified ostial vessel.A 3.00 x 16mm synergy xd drug eluting stent was implanted for treatment.However, during removal of the device, the rod separated from the balloon portion in the guide catheter.The stent delivery system (sds) broke at 121 cm from the hub.The device was removed as a whole and the procedure was completed.There were no patient complications nor injuries reported, and the patient condition was fine post-procedure.
Additional Manufacturer Narrative
A partial device was returned to the cis for analysis.Visual, tactile and microscopic analysis was performed on the device.Visual and tactile examination of the stent delivery system noted the stent was not returned.A 23cm portion of the polymer extrusion was returned with the balloon and tip.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the mildly tortuous and mildly calcified ostial vessel.A 3.00 x 16mm synergy xd drug eluting stent was implanted for treatment.However, during removal of the device, the rod separated from the balloon portion in the guide catheter.The stent delivery system (sds) broke at 121 cm from the hub.The device was removed as a whole and the procedure was completed.There were no patient complications nor injuries reported, and the patient condition was fine post-procedure.

• 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: 17324594
• Report Number: 2124215-2023-37007
• Device Sequence Number: 17807005
• Product Code: NIQ
• UDI-Device Identifier: 08714729980964
• UDI-Public: 08714729980964
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/16/2023

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: 12/13/2024
• Device Model Number: H7493941816300
• Device Lot Number: 0030755248
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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