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

Model Number	H7493941838220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.An opticross imaging catheter was used but became kinked inside the patient during delivery post-stent placement, resulting in a loss of imaging.The device was removed, and a 2.25 x 38 mm synergy xd drug-eluting stent (des) was selected for treatment.However, the stent broke at the proximal stainless-steel shaft and snapped inside the patient.The device was removed, and another 3.50 x 24 mm synergy xd des was then selected, but it also broke at the proximal stainless-steel shaft and snapped inside the patient.The device was also removed by just pulling them back out over the wire.The hub of both stents was detached outside the body.The procedure was completed with another of same device, and no patient complications were reported.
Additional Manufacturer Narrative
D4.Lot number updated.
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.An opticross imaging catheter was used but became kinked inside the patient during delivery post-stent placement, resulting in a loss of imaging.The device was removed, and a 2.25 x 38 mm synergy xd drug-eluting stent (des) was selected for treatment.However, the stent broke at the proximal stainless-steel shaft and snapped inside the patient.The device was removed, and another 3.50 x 24 mm synergy xd des was then selected, but it also broke at the proximal stainless-steel shaft and snapped inside the patient.The device was also removed by just pulling them back out over the wire.The hub of both stents was detached outside the body.The procedure was completed with another of same device, and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 2.25 x 38mm was returned for analysis.A visual, tactile and microscopic analysis was performed on the device.A break was identified, 19.6cm distal to the distal strain relief with multiple kinks also noted along the hypotube shaft.The distal segment of the break was not returned.
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.An opticross imaging catheter was used but became kinked inside the patient during delivery post-stent placement, resulting in a loss of imaging.The device was removed, and a 2.25 x 38 mm synergy xd drug-eluting stent (des) was selected for treatment.However, the stent broke at the proximal stainless-steel shaft and snapped inside the patient.The device was removed, and another 3.50 x 24 mm synergy xd des was then selected, but it also broke at the proximal stainless-steel shaft and snapped inside the patient.The device was also removed by just pulling them back out over the wire.The hub of both stents was detached outside the body.The procedure was completed with another of same device, and no patient complications were 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21688769
• Report Number: 2124215-2025-18309
• Device Sequence Number: 12928666
• Product Code: NIQ
• UDI-Device Identifier: 08714729980773
• UDI-Public: (01)08714729980773(17)260923(10)34953958
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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: 09/23/2026
• Device Model Number: H7493941838220
• Device Catalogue Number: H7493941838220
• Device Lot Number: 0034953958
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 05/08/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/30/2025; 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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