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

Lot Number	0030969648
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 20mm synergy megatron drug-eluting stent was advanced for treatment.However, in the middle of the procedure, the shaft broke proximally prior to stent deployment.No patient complications were reported, and no harm was done to the patient.
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 20mm synergy megatron drug-eluting stent was advanced for treatment.However, in the middle of the procedure, the shaft broke proximally prior to stent deployment.No patient complications were reported, and no harm was done to the patient.It was further reported that the 90% stenosed target lesion was located in the very tortuous, calcified, and acutely angled proximal right coronary artery.The device was removed completely, and the procedure was completed with a different device.
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 20mm synergy megatron drug-eluting stent was advanced for treatment.However, in the middle of the procedure, the shaft broke proximally prior to stent deployment.No patient complications were reported, and no harm was done to the patient.It was further reported that the 90% stenosed target lesion was located in the very tortuous, calcified, and acutely angled proximal right coronary artery.The device was removed completely, and the procedure was completed with a different device.
Additional Manufacturer Narrative
The device was returned to the cis for analysis.Visual, tactile, microscopic analysis and dimensional testing were performed on the device.Examination of the stent found stent damage at mid and proximal sections.Examination of the hypotube found a multiple kinks and a break at 16cm distal to the distal end of the strain relief.No other device issues were identified during returned product analysis.

• 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: 17785357
• Report Number: 2124215-2023-51522
• Device Sequence Number: 5472520
• Product Code: NIQ
• UDI-Device Identifier: 08714729985662
• UDI-Public: 08714729985662
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2023

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: 01/24/2024
• Device Lot Number: 0030969648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 09/21/2023; 10/19/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/03/2023; 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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
• Patient Sex: Unknown