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

Model Number	H7493941812220
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel dissection occurred.The target lesion was located in a severely calcified coronary artery.Two synergy xd drug-eluting stents, a 2.25 x 12mm and a 2.25 x 28mm, were advanced for treatment.The devices had difficulty crossing the lesion and dissection occurred.The patient was flown out for coronary artery bypass graft surgery.
Event or Problem Description
It was reported that vessel dissection occurred.The target lesion was located in a severely calcified coronary artery.Two synergy xd drug-eluting stents, a 2.25 x 12mm and a 2.25 x 28mm, were advanced for treatment.The devices had difficulty crossing the lesion and dissection occurred.The patient was flown out for coronary artery bypass graft surgery.It was further reported that the 70% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.The dissection was noticed immediately and was treated with long balloon inflation and stenting with a smaller stent.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14552233
• Report Number: 2134265-2022-06078
• Device Sequence Number: 6502824
• Product Code: NIQ
• UDI-Device Identifier: 08714729980711
• UDI-Public: 08714729980711
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: H7493941812220
• Device Lot Number: 0028443989
• 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: 05/20/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown