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

Model Number	H7493941816300
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.Following pre-dilatation with a 2.0x15 emerge balloon catheter, a 3.00 x 16mm synergy xd drug eluting stent was advanced for treatment.However, the device was unable to cross the lesion and it was noted that the shaft broke.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include the additional information received via gfe e1 - initial reporter email: updated details from other hcp to physician.
Event or Problem Description
It was reported that shaft break occurred.Following pre-dilatation with a 2.0x15 emerge balloon catheter, a 3.00 x 16mm synergy xd drug eluting stent was advanced for treatment.However, the device was unable to cross the lesion and it was noted that the shaft broke.No patient complications nor injuries were reported.It was further reported that the target lesion located in the right coronary artery/posterior distal artery (rca/pda) was 95% stenosed with moderate to severe calcification, severe tortuosity, and > 45 degrees bend.A 6f guidezilla ii guide extension catheter was used to deliver the stent.The stent catheter shaft broke about mid-shaft and was removed intact.The procedure was completed with another of same device and the patient was stable post-procedure.

• 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: 15801077
• Report Number: 2124215-2022-46846
• Device Sequence Number: 3062475
• Product Code: NIQ
• UDI-Device Identifier: 08714729980964
• UDI-Public: 08714729980964
• 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): 12/15/2022

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: 03/06/2024
• Device Model Number: H7493941816300
• Device Lot Number: 0029046255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE EXTENSION CATHETER: 6FR GUIDEZILLA II
• Patient Sex: Unknown