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

Lot Number 0025426096

Device Problem Migration (4003)

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

Event Date 10/04/2021

Event Type  Injury  

Event Description

It was reported that stent migrate to the proximal left main.The 90% stenosed target lesion was located in the moderately calcified and mildly tortuous left main coronary artery.A 4.50 x 24mm synergy megatron stent was selected for a procedure.While inflation the stent the balloon only filled with contrast on the distal part of the balloon, and the stent moved from the planed position in to the proximal left main.The stent placement was plan b and the physician was happy with the treatment.The procedure was completed successfully with this device.There were no patient complications and the patient was good post procedure.It was reported that stent migrate to the proximal left main.The 90% stenosed target lesion was located in the moderately calcified and mildly tortuous left main coronary artery.A 4.50 x 24mm synergy megatron stent was selected for a procedure.While inflation the stent the balloon only filled with contrast on the distal part of the balloon, and the stent moved from the planed position in to the proximal left main.The stent placement was plan b and the physician was happy with the treatment.The procedure was completed successfully with this device.There were no patient complications and the patient was good post procedure.

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12605150
• MDR Text Key: 276451705
• Report Number: 2134265-2021-12649
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Lot Number: 0025426096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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