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

Model Number	H7493942816400
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon difficulty removal from the stent occurred.The target lesion was located in the mildly tortuous and moderately calcified coronary artery.After the lesion was dilated with emerge balloon catheter and wolverine cutting balloon, a 4.00 x 16mm synergy megatron drug-eluting stent was advanced and deployed successfully.However, upon removal, the balloon was stuck and was difficult to remove from the stent.The wire, balloon and guide were removed with force and intact from the patient.The procedure was completed successfully and there were no patient complications reported.

• 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: 17337762
• Report Number: 2124215-2023-34824
• Device Sequence Number: 7331760
• Product Code: NIQ
• UDI-Device Identifier: 08714729985624
• UDI-Public: 08714729985624
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 07/17/2023

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: 08/23/2023
• Device Model Number: H7493942816400
• Device Lot Number: 0030040218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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 Sex: Unknown