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

Lot Number 0029981912

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 12/27/2023

Event Type  Injury  

Event Description

It was reported that the stent dislodged requiring additional intervention.The target lesion, located in the moderately calcified ostial right coronary artery (rca), was pre dilated and a 4.00 x 8 mm synergy megatron was advanced.During attempted deployment, it was noticed that the stent had "slipped off" the delivery system and was "loose" on the guidewire.Implantation of the device was not possible and the dislodged stent was retrieved via snare.An additional synergy megatron was used to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Video/media review by manufacturer: received to the complaint was a short video clip from the procedure.A review of the video available confirms the alleged stent dislodgement.The recording shows an undeployed stent sitting on a wire distally from the distal end of the guide catheter.In the following frame the stent is shown deployed (expanded) and located higher up than the delivery balloon at one side of the guide catheter.The balloon appears to have no contrast liquid inside it.

Event Description

It was reported that the stent dislodged requiring additional intervention.The target lesion, located in the moderately calcified ostial right coronary artery (rca), was pre dilated and a 4.00 x 8 mm synergy megatron was advanced.During attempted deployment, it was noticed that the stent had "slipped off" the delivery system and was "loose" on the guidewire.Implantation of the device was not possible and the dislodged stent was retrieved via snare.An additional synergy megatron was used to complete the procedure.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: 18503048
• MDR Text Key: 332780236
• Report Number: 2124215-2024-00698
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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: 0029981912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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