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

Lot Number	0030990882
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified circumflex artery.A 2.25 x 8mm synergy xd drug-eluting stent (des) was opened out of the package, but the shaft was visibly broken at proximal to the hub.Another 2.25 x 8mm synergy des was opened and advanced but it failed to cross the lesion.However, when the physician attempted to twist the stent, it did not look right, and upon removal from the sheath, the shaft was also broken at proximal to the stent balloon.The procedure was completed with a non-boston scientific device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 2.25 x 8mm was returned for analysis.A visual and tactile inspection revealed no issues identified with the hypotube shaft.A visual, tactile and microscopic examination of the outer and inner lumen and mid-shaft section identified a break at the guidewire exchange port with the distal section not returned for analysis.The stent, balloon and tip were not returned for analysis.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified circumflex artery.A 2.25 x 8mm synergy xd drug-eluting stent (des) was opened out of the package, but the shaft was visibly broken at proximal to the hub.Another 2.25 x 8mm synergy des was opened and advanced but it failed to cross the lesion.However, when the physician attempted to twist the stent, it did not look right, and upon removal from the sheath, the shaft was also broken at proximal to the stent balloon.The procedure was completed with a non-boston scientific device.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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19445844
• Report Number: 2124215-2024-31749
• Device Sequence Number: 8507603
• Product Code: NIQ
• UDI-Device Identifier: 08714729980704
• UDI-Public: 08714729980704
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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): 06/21/2024

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: 01/23/2025
• Device Lot Number: 0030990882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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