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

Lot Number	0032117237
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon became stuck in the stent struts.The target lesion was located in a non-tortuous and calcified left main (lm) artery.A 5.00 x 16mm synergy megatron drug-eluting stent was advanced to treat the lesion.Following stent deployment, the balloon was deflated and pulled back part way to post-dilate the proximal edge in the lm and use the proximal balloon as a proximal optimization technique (pot) technique.The balloon was deflated normally but got caught on the stent struts as it was deflated and became stuck.A 30mm balloon was inserted in the guide alongside the stent shaft and pinned the stent shaft against the inner guide.The system was then pulled out successfully.The stent was not affected and post-dilatation was performed with a new balloon to complete the procedure.The balloon was removed in a fully deflated state.The procedure was completed 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: 19098579
• Report Number: 2124215-2024-20262
• Device Sequence Number: 15407100
• Product Code: NIQ
• UDI-Device Identifier: 08714729985648
• UDI-Public: 08714729985648
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/12/2024

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: 07/10/2025
• Device Lot Number: 0032117237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male