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

Model Number	H7493942808500
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation issues occurred.The target lesion was located in a non- tortuous and moderately calcified left main coronary artery.A 5.00 x 8mm megatron drug-eluting stent was selected to use but during nstemi, there was an extreme difficulty removing the stent and noted that there was an uncomfortable amount of time to deflate the balloon.During balloon deflation, the patient was stable and did not feel any symptoms.When the balloon was about to be removed, it got stuck in the 6f cls 3.5 guide catheter.Eventually, the whole guide system and stent delivery had to be removed as a unit.The stent was deployed at 18 atmospheres (atm) and the balloon was re-inflated to 20 atmospheres (atm).The procedure was completed with this device and no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon deflation issues occurred.The target lesion was located in a non- tortuous and moderately calcified left main coronary artery.A 5.00 x 8mm megatron drug-eluting stent was selected to use but during nstemi, there was extreme difficulty removing the stent and it was noted that there was an uncomfortable amount of time needed to deflate the balloon.During balloon deflation, the patient was stable and did not feel any symptoms.When the balloon was about to be removed, it got stuck in the 6f cls 3.5 guide catheter.Eventually, the whole guide system and stent delivery had to be removed as a unit.The stent was deployed at 18 atmospheres (atm) and the balloon was re-inflated to 20 atmospheres (atm).The procedure was completed with this device and no patient complications nor injuries reported.It was further reported that there was no difficulty advancing the device over the wire through the 6f runway guide catheter.The stent was deployed with no issue using two inflations with an encore inflation device, the first at 18 atm and the second at 20 atm for 10 seconds.The stent was fully deployed with no issues and remained in the lesion.
Additional Manufacturer Narrative
The synergy megatron mr us 5.00 x 8mm stent delivery system (sds) was returned for analysis inserted through the reported 6f runway guide catheter on a 0.014inch size guidewire.No stent was returned as the stent was implanted in the patient.An examination of the balloon noted that the balloon was bunched towards its distal end and the balloon was forming a fold over the tip.There was contrast media visible inside the balloon.A visual, microscopic and tactile examination of the hypotube shaft found no damage.
Event or Problem Description
It was reported that balloon deflation issues occurred.The target lesion was located in a non- tortuous and moderately calcified left main coronary artery.A 5.00 x 8mm megatron drug-eluting stent was selected to use but during nstemi, there was extreme difficulty removing the stent and it was noted that there was an uncomfortable amount of time required to deflate the balloon.During balloon deflation, the patient was stable and did not feel any symptoms.When the balloon was about to be removed, it got stuck in the 6f cls 3.5 guide catheter.Eventually, the whole guide system and stent delivery had to be removed as a unit.The stent was deployed at 18 atmospheres (atm) and the balloon was re-inflated to 20 atmospheres (atm).The procedure was completed with this device and no patient complications nor injuries reported.It was further reported that there was no difficulty advancing the device over the wire through the 6f runway guide catheter.The stent was deployed with no issue using two inflations with an encore inflation device, the first at 18 atm and the second at 20 atm for 10 seconds.The stent was fully deployed with no issues and remained in the lesion.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15852138
• Report Number: 2124215-2022-46330
• Device Sequence Number: 12066229
• Product Code: NIQ
• UDI-Device Identifier: 08714729985563
• UDI-Public: 08714729985563
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 12/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2023
• Device Model Number: H7493942808500
• Device Lot Number: 0028887982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 12/21/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/05/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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: GUIDE CATHETER: 6F CLS3.5; GUIDE CATHETER: 6F RUNWAY CLS3.5; GUIDE CATHETER: 6F RUNWAY CLS3.5
• Patient Sex: Unknown