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

Model Number	H7493942824500
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, removal difficulties and vessel dissection occurred.The stenosed target lesion was less than 60% located in the moderately tortuous and severely calcified proximal right coronary artery.After the non-boston scientific guidewire crossed the lesion, a 5.00 x 24mm synergy megatron drug-eluting stent was then placed for treatment.It was noted that physician aware that the balloon platform was a larger than the normal balloon of workhorse stents.So, the devices were removed all at once, however, during removal, the tip of the stent balloon ruptured at 24 atmospheres in 16 seconds and would not come out from the sheath.It was noted that the physician did not give the balloon time enough to deflate before pulling back into the guide catheter.Hence, resulted into dissection of the right common iliac artery.The procedure was competed successfully, and no further patient complications reported.The patient status was stable post-procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy megatron mr us 5.00 x 24mm stent delivery system, catheter was returned to the complaint investigation site.Visual, tactile and microscopic and functional testing was performed on the device.Multiple hypotube kinks were noted and the guide catheter was attached to the device and could not be removed.The polymer extrusion was damaged 7.3cm from the tip of the device and the proximal markerband was pulled distally.The balloon had already been subjected to positive pressure and was inflated to rpb but could not be deflated.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that balloon rupture, removal difficulties and vessel dissection occurred.The stenosed target lesion was less than 60% located in the moderately tortuous and severely calcified proximal right coronary artery.After the non-boston scientific guidewire crossed the lesion, a 5.00 x 24mm synergy megatron drug-eluting stent was then placed for treatment.It was noted that physician aware that the balloon platform was a larger than the normal balloon of workhorse stents.So, the devices were removed all at once, however, during removal, the tip of the stent balloon ruptured at 24 atmospheres in 16 seconds and would not come out from the sheath.It was noted that the physician did not give the balloon time enough to deflate before pulling back into the guide catheter.Hence, resulted into dissection of the right common iliac artery.The procedure was competed successfully, and no further patient complications reported.The patient status was stable post-procedure.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: 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: 17119503
• Report Number: 2124215-2023-28776
• Device Sequence Number: 12520679
• Product Code: NIQ
• UDI-Device Identifier: 08714729985723
• UDI-Public: 08714729985723
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2024
• Device Model Number: H7493942824500
• Device Lot Number: 0030856173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown