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

Model Number	H7493941812350
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and upon removal, the hypotube section of the shaft was fractured.The physician grabbed the remaining wire to pull out the end with the stent.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and upon removal, the hypotube section of the shaft was fractured.The physician grabbed the remaining wire to pull out the end with the stent.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the break occurred approximately 129 cm from the hub.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.50 x 12mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage with proximal struts lifted.The undamaged stent outer diameter was measured 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 damage.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft and a break 22.5 cm distal to distal strain relief.A visual and tactile examination of the outer and mid-shaft section found no issues.No other issues noted with device.B5.Describe event or problem- updated.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and upon removal, the hypotube section of the shaft was fractured.The physician grabbed the remaining wire to pull out the end with the stent.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the break occurred approximately 129 cm from the hub.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15234731
• Report Number: 2134265-2022-08503
• Device Sequence Number: 6446744
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2022

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: 07/13/2023
• Device Model Number: H7493941812350
• Device Lot Number: 0027715496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 09/21/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/12/2022; 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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