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

Model Number	H7493942832450
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The patient presented for percutaneous coronary intervention in a saphenous vein graft.After inserting a 6f sheath and placing a 6f guide catheter, a 4.50 x 32mm synergy megatron drug-eluting stent was advanced and deployed.However, during withdrawal, the stent balloon would not rewrap tight enough to fit through the guide catheter opening.After a struggle to get it through the guide catheter, it would then not fit through the sheath.The physician "snapped" the balloon through the sheath and was then able to remove it.The same scenario happened with the second 4.50 x 32mm synergy megatron drug-eluting stent deployed.The physician needed to deploy a third synergy megatron drug-eluting stent and upsized to 8f.The procedure was completed with no patient complications.

• Brand Name: SYNERGY MEGATRON
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16313725
• Report Number: 2124215-2023-04455
• Device Sequence Number: 15002832
• Product Code: NIQ
• UDI-Device Identifier: 08714729985792
• UDI-Public: 08714729985792
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2023
• Device Model Number: H7493942832450
• Device Lot Number: 0028962908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White