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

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

It was reported that difficulties removing a balloon occurred.The target lesion was located in the ostial right coronary artery (rca).A 5.00 x 16mm synergy megatron stent was deployed normally in the rca.However, the stent balloon was unable to be retracted through the guide catheter.Negative pressure was drawn on the balloon, 30 seconds were attempted to deflate the balloon, but the issue did not resolve.The delivery system was removed intact together with the guide catheter.It was noted that no physical damage was observed, the balloon was deflated prior to attempting to remove the balloon, difficulties removing the balloon from the stent occurred, and upon removal, the balloon appeared to be partially deflated.The procedure was completed and no patient complications resulted in relation to this event.

Event Description

It was reported that difficulties removing a balloon occurred.The target lesion was located in the ostial right coronary artery (rca).A 5.00 x 16mm synergy megatron stent was deployed normally in the rca.However, the stent balloon was unable to be retracted through the guide catheter.Negative pressure was drawn on the balloon, 30 seconds were attempted to deflate the balloon, but the issue did not resolve.The delivery system was removed intact together with the guide catheter.It was noted that no physical damage was observed, the balloon was deflated prior to attempting to remove the balloon, difficulties removing the balloon from the stent occurred, and upon removal, the balloon appeared to be partially deflated.The procedure was completed and no patient complications resulted in relation to this event.It was further reported that a 6f guide catheter was used during the procedure.No resistance was encountered while advancing the device in the guide catheter or over the wire before deployment of the stent or balloon inflation.A ration of 60% saline and 40% contrast media was used during the procedure.There was no attempt to withdraw an unexpanded stent back through the guide catheter.The catheter balloon was only inflated and deflated once after the initial stent deployment.Complete deflation was visualized under fluoroscopy before removing the balloon.There was no engagement with the stent and or guide catheter tip during withdrawal.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13515863
• MDR Text Key: 285645405
• Report Number: 2134265-2022-01515
• Device Sequence Number: 1
• Product Code: NIQ
• 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,Followup
• Report Date: 02/21/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1