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

Model Number	H7493942816450
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment and removal difficulties occurred.The patient was presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.50 x 16mm synergy megatron drug-eluting stent was advanced for treatment.After stent deployment, the stent balloon was deflated but removal difficulty was encountered.The distal portion of the balloon was prolapsed and was stuck on the guide catheter despite multiple negative pressure pulls on the balloon port.Finally, the entire system was removed, and a new guide catheter, guidewire, and balloon were reintroduced for post-dilatation to complete the procedure.There were no patient complications nor injuries were reported.
Additional Manufacturer Narrative
H6 device codes: corrected.
Event or Problem Description
It was reported that catheter entrapment and removal difficulties occurred.The patient was presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.50 x 16mm synergy megatron drug-eluting stent was advanced for treatment.After stent deployment, the stent balloon was deflated but removal difficulty was encountered.The distal portion of the balloon was prolapsed and was stuck on the guide catheter despite multiple negative pressure pulls on the balloon port.Finally, the entire system was removed, and a new guide catheter, guidewire, and balloon were reintroduced for post-dilatation to complete the procedure.There were no patient complications nor injuries were reported.It was further reported that vascular access was obtained via right radial artery.The target lesion was located in proximal right coronary artery.A 6 french fr4 runway guide catheter was engaged during the procedure.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16715843
• Report Number: 2124215-2023-16889
• Device Sequence Number: 7264212
• Product Code: NIQ
• UDI-Device Identifier: 08714729985631
• UDI-Public: 08714729985631
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 05/01/2023

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: 07/06/2023
• Device Model Number: H7493942816450
• Device Lot Number: 0029787355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 84 KG