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

Lot Number	0030446045
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the device failed to cross the lesion and noted to be fractured.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy xd mr us 3.00 x 20mm stent delivery system (sds) was returned for analysis.No issues were noted on the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.There was no sign of damage, stretching or lifting of the stent struts.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the device failed to cross the lesion and noted to be fractured.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

• 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: 17809654
• Report Number: 2124215-2023-51548
• Device Sequence Number: 7380327
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: 08714729980971
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• 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): 10/19/2023

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: 10/16/2024
• Device Lot Number: 0030446045
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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 Age: 80 YR
• Patient Sex: Female