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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Cardiac Enzyme Elevation (1838); Obstruction/Occlusion (2422)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that re-occlusion occurred.The 95% stenosed target lesion was located in the severely calcified and moderately tortuous left anterior descending artery (lad) and the severely calcified and severely tortuous diagonal artery.On (b)(6) 2023, a 2.50 x 28mm synergy xd drug eluting stent was placed in the diagonal artery and a 3.00 x 48mm synergy xd drug eluting stent was placed in the lad using a culotte bifurcation technique.The stents were post dilated individually and using a kissing balloon technique.On (b)(6) 2023, the patient presented with chest pain and elevated troponins.Cardiac catheterization showed that the 3.00 x 48mm synergy xd was occluded.The stents had to be ballooned to open for flow and the patient was discharged to cardiac rehabilitation.

• 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: 18193598
• Report Number: 2124215-2023-66146
• Device Sequence Number: 15391812
• Product Code: NIQ
• UDI-Device Identifier: 08714729985228
• UDI-Public: 08714729985228
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: White