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

Lot Number	0033509554
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 3.00 x 48mm synergy xd drug-eluting stent was advanced but difficulties in crossing the lesion was encountered.However, when pushing the stent further, the shaft broke in half outside the watchdog device.The device was pulled out and was successfully removed.The procedure was completed with a non-boston scientific device with no patient complications reported.
Additional Manufacturer Narrative
The device was returned with analysis.A visual and tactile examination of the hypotube shaft identified a break at 20.5cm distal to the distal end of the strain relief.Multiple hypotube kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A microscopic analysis revealed no sign of damage, stretching or lifting of the stent struts.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 90% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 3.00 x 48mm synergy xd drug-eluting stent was advanced but difficulties in crossing the lesion was encountered.However, when pushing the stent further, the shaft broke in half outside the watchdog device.The device was pulled out and was successfully removed.The procedure was completed with a non-boston scientific device with no patient complications reported.

• 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: 19406534
• Report Number: 2124215-2024-32219
• Device Sequence Number: 12501607
• Product Code: NIQ
• UDI-Device Identifier: 08714729985228
• UDI-Public: 08714729985228
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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
• Report Date (Section B): 07/12/2024

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: 02/19/2026
• Device Lot Number: 0033509554
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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