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

Model Number H7493942832400

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

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

Event Date 06/22/2023

Event Type  malfunction  

Event Description

It was reported that removal difficulties and catheter entrapment occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified left main coronary artery.A 4.00 x 32mm synergy megatron drug-eluting stent was advanced for treatment.The stent balloon was inflated at 14 atmospheres for roughly 15 seconds and the stent was deployed.After waiting 20-30 seconds for the balloon to fully deflate, removal difficulties were encountered.The stent balloon became stuck in the proximal portion of the guide catheter and the guidewire appeared to be stuck to the balloon.The balloon was still stuck even after pulling back pressure/vacuum on the indeflator a second time.The stent balloon, wire, and guide catheter had to be removed as one unit.The procedure was completed with no patient complications were 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: 17329879
• MDR Text Key: 319512043
• Report Number: 2124215-2023-34701
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985785
• UDI-Public: 08714729985785
• 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: 07/14/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2024
• Device Model Number: H7493942832400
• Device Lot Number: 0030832797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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
• Treatment: GUIDE CATHETER: MDT EBU 4.0 7F