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

Model Number	H7493942816500
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon failed to deflate and a vessel occlusion occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified proximal left main lesion.A 5.00 x 16mm synergy megatron was selected for use in the percutaneous coronary intervention (pci) procedure.There a significant bend involved in the lesion.The lesion pre dilated with 1.5,2.5 and 3.0 nc emerge balloon.There was no difficulty advancing the device over a non boston scientific wire and through the guide catheter.The synergy megatron stent had delivered through the struts of a transcatheter aortic valve replacement (tavr) valve.The synergy was delivered to the lesion site and the balloon inflated once at 12 atmospheres for 10 seconds.After the stent implanted, the physician attempted to deflate the balloon for 20 seconds, but the balloon was unable to deflate, retrieve and vessel occlusion occurred.Then, the physician cut the back end of the stent catheter and deliver a guide extension catheter over it in order to retrieve the balloon.The device was removed by sheathing it inside of a guide extension catheter and the balloon was removed in partially inflated.It was notice the balloon was stretched and deformed upon retrieval, and the device removed from the patient intact.The guidewire able to be removed from the device once outside the patient.The procedure was completed with this device.There were no further patient complications, the patient was stable and fully recovered at the end of the procedure.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: 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: 13523189
• Report Number: 2134265-2022-01511
• Device Sequence Number: 5298930
• Product Code: NIQ
• UDI-Device Identifier: 08714729985648
• UDI-Public: 08714729985648
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 02/14/2022

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: 04/12/2022
• Device Model Number: H7493942816500
• Device Lot Number: 0027201083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1.5NC EMERGE BALLOON BOSTON SCIENTIFIC; 2.5NC EMERGE BALLOON BOSTON SCIENTIFIC; 3.0 NC EMERGE BALLOON BOSTON SCIENTIFIC; BMW GUIDE WIRE - ABBOTT
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Race: Black Or African American