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

Model Number	H7493942808450
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease (cad).Percutaneous coronary intervention (pci) was performed in right coronary artery.A 4.50 x 8mm synergy megatron drug-eluting stent was advanced for treatment.However, the shaft was broken.A 4.5 x 12 mm nc emerge balloon catheter was used and completed the procedure successfully.No patient complications were reported.
Additional Manufacturer Narrative
This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgements from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease (cad).Percutaneous coronary intervention (pci) was performed in right coronary artery.A 4.50 x 8mm synergy megatron drug-eluting stent was advanced for treatment.However, the shaft was broken.A 4.5 x 12 mm nc emerge balloon catheter was used and completed the procedure successfully.No patient complications were reported.It was further reported that the 90% stenosed target lesion was located in the mildly tortuous and severely calcified ostial right coronary artery.After the 4.50 x 8mm synergy megatron drug-eluting stent was implanted, the balloon was deflated but was not able to be removed easily from the stent.The physician pulled the device back but the shaft broke at approximately 100 cm from the hub inside the guiding catheter.The distal portion of the device was removed without any issues and post-dilatation was performed with the 4.5 x 12 mm nc emerge balloon catheter.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease (cad).Percutaneous coronary intervention (pci) was performed in right coronary artery.A 4.50 x 8mm synergy megatron drug-eluting stent was advanced for treatment.However, the shaft was broken.A 4.5 x 12 mm nc emerge balloon catheter was used and completed the procedure successfully.No patient complications were reported.It was further reported that the 90% stenosed target lesion was located in the mildly tortuous and severely calcified ostial right coronary artery.After the 4.50 x 8mm synergy megatron drug-eluting stent was implanted, the balloon was deflated but was not able to be removed easily from the stent.The physician pulled the device back but the shaft broke at approximately 100 cm from the hub inside the guiding catheter.The distal portion of the device was removed without any issues and post-dilatation was performed with the 4.5 x 12 mm nc emerge balloon catheter.
Additional Manufacturer Narrative
This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgements from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.Device evaluated by mfr.: synergy megatron mr us 4.50 x 8mmmm stent delivery system was returned for analysis.No stent was returned; the stent was implanted in the patient.The balloon cones were reviewed, and the balloon was in a deflated state with traces of blood inside.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.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 site of the wire exchange port.No other issues were identified during analysis.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16529992
• Report Number: 2124215-2023-11204
• Device Sequence Number: 2905052
• Product Code: NIQ
• UDI-Device Identifier: 08714729985556
• UDI-Public: 08714729985556
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/22/2023

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: 07/27/2023
• Device Model Number: H7493942808450
• Device Lot Number: 0029899965
• 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: 03/02/2023
• Supplement Date Received by Manufacturer: 03/10/2023; 05/11/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/20/2023; 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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
• Patient Sex: Unknown