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

Model Number H7493942820450

Device Problems Break (1069); Entrapment of Device (1212); Material Deformation (2976)

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

Event Date 04/25/2023

Event Type  Injury  

Event Description

It was reported that device entrapment, shaft break, and stent damage occurred.The patient was being treated for coronary artery disease in the left main artery lesion using impella support.Following deployment of a 4.50 x 20mm synergy megatron drug-eluting stent, the stent balloon was withdrawn but it could not be removed from the guide catheter and would not move.Balloon advancement was attempted and to re-inflate, but advancement was not possible.No devices were able to move past the balloon that was stuck in the guide catheter, an attempt to pull was done and the balloon shaft broke off of the delivery system.The broken shaft and balloon were retrieved after many hours trying to use a snare.Following removal, it was noted that the stent was still attached to the balloon but was mangled and deformed.The procedure was completed with a synergy xd drug-eluting stent and the patient was fully recovered.

Manufacturer Narrative

Device evaluated by manufacturer: a synergy megatron mr us 4.50 x 20mm was returned for analysis.A visual, tactile and microscopic examination was performed on the returned device.Device analysis can confirm that a break did occur in the midshaft extrusion.An examination of the distal extrusion identified clear evidence that excessive tensile forces had been applied to the distal extrusion shaft, which resulted in the break in the midshaft extrusion.The midshaft was severely stretched and necked down along both sections of the break.This stretching to the distal extrusion extended distally beyond the guidewire exit port.Further analysis identified no tears or holes in the balloon.However, there was a large build-up of solidified blood inside the balloon.Due to the condition of the returned device it was not possible to inflate the balloon in order to test for leaks.The actual stent was not return for analysis.Device analysis confirms the reported event of a break in the distal extrusion.An examination of the break site identified clear evidence of excessive tensile forces having been applied to the device.

Event Description

It was reported that device entrapment, shaft break, and stent damage occurred.The patient was being treated for coronary artery disease in the left main artery lesion using impella support.Following deployment of a 4.50 x 20mm synergy megatron drug-eluting stent, the stent balloon was withdrawn but it could not be removed from the guide catheter and would not move.Balloon advancement was attempted and to re-inflate, but advancement was not possible.No devices were able to move past the balloon that was stuck in the guide catheter, an attempt to pull was done and the balloon shaft broke off of the delivery system.The broken shaft and balloon were retrieved after many hours trying to use a snare.Following removal, it was noted that the stent was still attached to the balloon but was mangled and deformed.The procedure was completed with a synergy xd drug-eluting stent and the patient was fully recovered.

• 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: 16940285
• MDR Text Key: 315311869
• Report Number: 2124215-2023-23721
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985679
• UDI-Public: 08714729985679
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2023
• Device Model Number: H7493942820450
• Device Lot Number: 0030159547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2022
• 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