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

Lot Number 0028784743

Device Problems Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Pulmonary Edema (2020)

Event Date 09/01/2022

Event Type  Injury  

Event Description

It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on the left main (lm).A 4.00 x 20mm synergy megatron was delivered successfully to the lm and deployed.Following deployment, the stent balloon was used to post dilate the lesion at 18 bar.However, difficulties pulling the balloon into the guide catheter occurred, and the balloon became stuck.It had become stuck in the opening of the guide catheter.While trying to remove the balloon, a shaft break occurred.It was noted that the patient experienced edema.The procedure was completed.No further patient complications resulted in relation to this event.It was further clarified that the patient experienced lung edema, fluid in the lung due to the heart struggling while the balloon was occluding the left main artery.No further patient complications were reported in relation to this event.

Event Description

It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on the left main (lm).A 4.00 x 20mm synergy megatron was delivered successfully to the lm and deployed.Following deployment, the stent balloon was used to post dilate the lesion at 18 bar.However, difficulties pulling the balloon into the guide catheter occurred, and the balloon became stuck.It had become stuck in the opening of the guide catheter.While trying to remove the balloon, a shaft break occurred.It was noted that the patient experienced edema.The procedure was completed.No further patient complications resulted in relation to this event.It was further clarified that the patient experienced lung edema (fluid in the lung due to the heart struggling while the balloon was occluding the left main artery.No further patient complications were reported in relation to this event.It was further reported that the 70 to 80% stenosed target lesion was located in the lm.The stent balloon was possibly inflated 3 times.The balloon was noted to have been fully deflated prior to removing the delivery system.The physician's assessment for the cause of the shaft break was noted to have been due to either weakness in the shaft or due to the difficulty experienced when removing the balloon and had become stuck.Everything had been removed from the patient, and the procedure was completed.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Additional information, updated initial reporter details.

Event Description

It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on the left main (lm).A 4.00 x 20mm synergy megatron was delivered successfully to the lm and deployed.Following deployment, the stent balloon was used to post dilate the lesion at 18 bar.However, difficulties pulling the balloon into the guide catheter occurred, and the balloon became stuck.It had become stuck in the opening of the guide catheter.While trying to remove the balloon, a shaft break occurred.It was noted that the patient experienced edema.The procedure was completed.No further patient complications resulted in relation to this event.It was further clarified that the patient experienced lung edema, fluid in the lung due to the heart struggling while the balloon was occluding the left main artery.No further patient complications were reported in relation to this event.It was further reported that the 70 to 80% stenosed target lesion was located in the lm.The stent balloon was possibly inflated 3 times.The balloon was noted to have been fully deflated prior to removing the delivery system.The physician's assessment for the cause of the shaft break was noted to have been due to either weakness in the shaft or due to the difficulty experienced when removing the balloon and had become stuck.Everything had been removed from the patient, and the procedure was completed.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Device evaluated by manufacturer: synergy megatron mr ous 4.00 x 20mm stent delivery system (sds), was returned for analysis, the following attributes were examined: stent profile: the stent was not returned.Balloon profile: the balloon cones were reviewed, and distal balloon bunching was identified.Tip profile: a visual and microscopic examination of the bumper tip showed no signs of distal tip damage.Hypotube profile: a visual and tactile examination of the hypotube shaft found multiple kinks.Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a shaft break at the wire exchange port - unable to inflate due to break.Device-to-device interaction test - device could not load through guide past point of balloon bunching.No other issues were identified during analysis.

Event Description

It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on the left main (lm).A 4.00 x 20mm synergy megatron was delivered successfully to the lm and deployed.Following deployment, the stent balloon was used to post dilate the lesion at 18 bar.However, difficulties pulling the balloon into the guide catheter occurred, and the balloon became stuck.It had become stuck in the opening of the guide catheter.While trying to remove the balloon, a shaft break occurred.It was noted that the patient experienced edema.The procedure was completed.No further patient complications resulted in relation to this event.It was further clarified that the patient experienced lung edema (fluid in the lung due to the heart struggling while the balloon was occluding the left main artery.No further patient complications were reported in relation to this event.It was further reported that the 70 to 80% stenosed target lesion was located in the lm.The stent balloon was possibly inflated 3 times.The balloon was noted to have been fully deflated prior to removing the delivery system.The physician's assessment for the cause of the shaft break was noted to have been due to either weakness in the shaft or due to the difficulty experienced when removing the balloon and had become stuck.Everything had been removed from the patient, and the procedure was completed.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Correction to h6 evaluation conclusion codes.Initially reported as unintended use error caused or contributed to event and corrected to failure to follow instructions.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15430920
• MDR Text Key: 299992027
• Report Number: 2124215-2022-36226
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2024
• Device Lot Number: 0028784743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other