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

Model Number	H7493941828250
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a peripheral arterial vessel.A 2.50 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during introduction, it was noticed that the shaft was kinked and it eventually snapped.The device was pulled out from the sheath without issue.The procedure was completed with another 2.50 x 24mm synergy xd drug-eluting stent.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a peripheral arterial vessel.A 2.50 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during introduction, it was noticed that the shaft was kinked and it eventually snapped.The device was pulled out from the sheath without issue.The procedure was completed with another 2.50 x 24mm synergy xd drug-eluting stent.No patient complications were reported.
Additional Manufacturer Narrative
D4 - lot number: updated to 0030411136.
Additional Manufacturer Narrative
H6 - evaluation conclusion code: updated from adverse event related to procedure to cause traced to intentional off-label, unapproved, or contraindicated use.Device evaluated by mfr: the device was returned to the cis for analysis.Visual, tactile and microscopic analysis was performed on the device.Visual and tactile examination identified multiple hypotube kinks and a shaft break at 58cm distal to the distal end of the strain relief.Examination of the outer and inner lumen and mid-shaft section of the shaft polymer extrusion profile found a break at the site of the wire exchange port.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a peripheral arterial vessel.A 2.50 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during introduction, it was noticed that the shaft was kinked and it eventually snapped.The device was pulled out from the sheath without issue.The procedure was completed with another 2.50 x 24mm synergy xd drug-eluting stent.No patient complications were reported.It was further reported that the stent was used for treatment of a peripheral vascular disease in the anterior tibial artery.

• 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: 16895758
• Report Number: 2124215-2023-21554
• Device Sequence Number: 6312064
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: 08714729980834
• 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,Followup
• Report Date (Section B): 08/28/2023

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: 10/11/2024
• Device Model Number: H7493941828250
• Device Lot Number: 0030411136
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 06/26/2023; 08/10/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/01/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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