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

Lot Number	0031083410
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter difficulty removal occurred.The 70% stenosed target lesion was located in the not very tortuous and moderately calcified left circumflex artery (lcx).A non-bsc guide was used to predilate the lesion with a 3 x 12mm nc emerge and successfully implanted a 3.50 x 16mm synergy megatron drug-eluting stent.However, during the removal of the stent delivery system (sds), it would not come back through the guide.Everything was successfully removed after multiple attempts of inflating and deflating the balloon at both low and high pressures.The procedure was completed with the original device.There were no patient complications reported.
Event or Problem Description
It was reported that catheter difficulty removal occurred.The 70% stenosed target lesion was located in the not very tortuous and moderately calcified left circumflex artery (lcx).A non-bsc guide was used to predilate the lesion with a 3 x 12mm nc emerge and successfully implanted a 3.50 x 16mm synergy megatron drug-eluting stent.However, during the removal of the stent delivery system (sds), it would not come back through the guide.Everything was successfully removed after multiple attempts of inflating and deflating the balloon at both low and high pressures.The procedure was completed with the original device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy megatron mr us 3.50 x 16mm stent delivery system (sds) was returned for analysis.A visual examination performed, and device was inserted through the guide catheter with the guidewire inserted through the wire lumen.Exposed from the tip of the guide was approximately 2mm of the distal end of the balloon.When the device was removed from the guide (without the use of an excessive force) it was identified that the distal and midshaft extrusion had been severely stretched.No tears or holes were observed in the extrusion.Microscopic revealed the stent was implanted in the patient and therefore was not returned.When the device was withdrawn from the guide, a visual and microscopic examination of the balloon material identified no tears or holes in the balloon.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual, microscopic and device to device interaction test was performed.When the device was placed under vacuum, it was possible to retract the device back out from the guide with no resistance noted.When the device was removed from the guide (without the use of an excessive force) it was identified that the distal extrusion had been severely stretched.

• 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: 18796619
• Report Number: 2124215-2024-11737
• Device Sequence Number: 17936595
• Product Code: NIQ
• UDI-Device Identifier: 08714729985617
• UDI-Public: 08714729985617
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: 02/08/2024
• Device Lot Number: 0031083410
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLON USED TO PREDILATE: 3 X 12MM NC EMERGE; BALLON USED TO PREDILATE: 3 X 12MM NC EMERGE
• Patient Sex: Male