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

Lot Number	0031669521
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/24/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that the removal difficulties and shaft break occurred; and the patient died.The patient presented with severe aortic stenosis (as) and was sent to catheterization lab as st elevation myocardial infarction.Vascular access was obtained via right radial access.The 90% occluded target lesion was located in the moderately calcified and non-tortuous ostial left main (lm) artery.A 6f jl 3.5 guide with side holes together with a.014 non- boston scientific (bsc) guidewire was advanced for treatment.The lesion was directly stented with a 5.00 x 8 megatron drug eluting stent at the ostium of the lm.When attempting to remove the balloon of the stent delivery system (sds), the sds became stuck in the stent in lm and the distal shaft was separated.The proximal shaft of the sds was removed but the distal part remained in the patient.The physician attempted to pull negative on the balloon multiple times without success and also attempted to inflate and then deflate the balloon with gentle pull back of the sds; however, these were unsuccessful.Physician attempted to implant mechanical circulatory support (mcs), but due to severe as it could not be completed.The patient then coded and expired before other removal attempts could be performed.

• Brand Name: SYNERGY MEGATRON
• 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: 17760383
• Report Number: 2124215-2023-49975
• Device Sequence Number: 6664678
• Product Code: NIQ
• UDI-Device Identifier: 08714729985563
• UDI-Public: 08714729985563
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 09/15/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2024
• Device Lot Number: 0031669521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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: Death
• Patient Age: 82 YR
• Patient Sex: Male