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

Lot Number 0029621612

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

Patient Problems Ventricular Fibrillation (2130); Thrombosis/Thrombus (4440)

Event Date 02/10/2023

Event Type  Injury  

Event Description

It was reported that ventricular fibrillation and thrombosis occurred.The patient presented unstable with several st elevations.The 90% stenosed target lesion was located in the moderately calcified and severely tortuous proximal to mid left anterior descending artery (lad).A 75% stenosis was also observed in the lad on the distal side of the target lesion.Angiography confirmed st elevation, so distal lad was left and a 2.75 x 38mm synergy xd was placed in proximal to mid lad.Good dilation was confirmed with intravascular ultrasound (ivus).The patient became stable, and the procedure was about to be completed.However, ventricular fibrillation (vf) occurred about 20 minutes after stent implantation.Insertion and post-dilation of the impella was performed.It was noted that there was a slight possibility of thrombosis with confirmation imaging performed on 13th feb.If the progress is favorable, impella will be removed.Per physician, implantation of the 2.75 x 38mm synergy xd did not contribute to the vf.As for the thrombus, due to severe calcification, plaque-rich areas behind the calcification may have been released into the blood vessels during the procedure.Thrombus was not caused by the synergy.No further patient complications were reported.

Event Description

It was reported that ventricular fibrillation and thrombosis occurred.The patient presented unstable with several st elevations.The 90% stenosed target lesion was located in the moderately calcified and severely tortuous proximal to mid left anterior descending artery (lad).A 75% stenosis was also observed in the lad on the distal side of the target lesion.Angiography confirmed st elevation, so distal lad was left and a 2.75 x 38mm synergy xd was placed in proximal to mid lad.Good dilation was confirmed with intravascular ultrasound (ivus).The patient became stable, and the procedure was about to be completed.However, ventricular fibrillation (vf) occurred about 20 minutes after stent implantation.Insertion and post-dilation of the impella was performed.It was noted that there was a slight possibility of thrombosis with confirmation imaging performed on 13th feb.If the progress is favorable, impella will be removed.Per physician, implantation of the 2.75 x 38mm synergy xd did not contribute to the vf.As for the thrombus, due to severe calcification, plaque-rich areas behind the calcification may have been released into the blood vessels during the procedure.Thrombus was not caused by the synergy.No further patient complications were reported.It was further reported that the thrombus was located in the treated target vessel.

• Brand Name: SYNERGY XD
• Type of Device: 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: 16499555
• MDR Text Key: 310836475
• Report Number: 2124215-2023-07562
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 0029621612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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