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

Model Number	H7493942828350
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent damage post-deployment occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified aorto-ostial right coronary artery (rca).A 3.50 x 28mm synergy megatron drug-eluting stent was advanced for treatment.However, after initial deployment of the stent, interaction with the guide catheter caused axial deformation of the stent.As a result, subsequent post inflation ballooning was made difficult.A new wire was placed outside the first row of megatron stent struts and balloons were used in a "crush" technique to create an opening.Then, a new stent was deployed at the ostium rca and the procedure was successful.The patient then underwent angiogram of the target lesion located in the non-tortuous mid to distal right coronary artery.A 2.50mm x 12mm nc emerge was advanced and deployed for treatment.However, during withdrawal, the hypotube broke just proximal to the balloon and remained inside the patient.A new stent was placed to pin the balloon fragment onto another stent to avoid migration.No further patient complications were 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: 17290591
• Report Number: 2124215-2023-33881
• Device Sequence Number: 6319515
• Product Code: NIQ
• UDI-Device Identifier: 08714729985730
• UDI-Public: 08714729985730
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 07/10/2023

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: 08/25/2023
• Device Model Number: H7493942828350
• Device Lot Number: 0030083447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown