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

Model Number	H7493941816250
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 75% stenosed target lesion was located in a mildly tortuous and severely calcified coronary artery.A 2.50 x 16mm synergy xd drug-eluting stent was advanced for treatment but it could not cross the lesion due to highly calcified lesion.However, it was found that the shaft broke during crossing the lesion.The device was simply removed in one piece and the procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: synergy xd mr us 2.50 x 16mm stent delivery system (sds) was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break at 21.2cm distal to the distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic analysis revealed that 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 75% stenosed target lesion was located in a mildly tortuous and severely calcified coronary artery.A 2.50 x 16mm synergy xd drug-eluting stent was advanced for treatment but it could not cross the lesion due to highly calcified lesion.However, it was found that the shaft broke during crossing the lesion.The device was simply removed in one piece and the procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: synergy xd mr us 2.50 x 16mm stent delivery system (sds) was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break at 21.2cm distal to the distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic analysis revealed that 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 75% stenosed target lesion was located in a mildly tortuous and severely calcified coronary artery.A 2.50 x 16mm synergy xd drug-eluting stent was advanced for treatment but it could not cross the lesion due to highly calcified lesion.However, it was found that the shaft broke during crossing the lesion.The device was simply removed in one piece and the procedure was completed with another of same device.There were no patient complications reported.As per further review, it was not stated that the 2.50 x 16mm synergy xd drug-eluting stent failed to cross the lesion.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20820968
• Report Number: 2124215-2024-75647
• Device Sequence Number: 7683866
• Product Code: NIQ
• UDI-Device Identifier: 08714729980803
• UDI-Public: 08714729980803
• Combination Product (Y/N): Y
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2025

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: 06/27/2025
• Device Model Number: H7493941816250
• Device Catalogue Number: H7493941816250
• Device Lot Number: 0031990123
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 02/06/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/22/2025; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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