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

Lot Number 0032117237

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2024

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 340047520
• Report Number: 2124215-2024-20262
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985648
• UDI-Public: 08714729985648
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Lot Number: 0032117237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male