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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Cardiac Enzyme Elevation (1838); Obstruction/Occlusion (2422)

Event Date 11/08/2023

Event Type  Injury  

Event 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 november 8, 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
• Type of Device: 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: 18193510
• MDR Text Key: 328883983
• Report Number: 2124215-2023-66148
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: 08714729980834
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: White