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

Model Number	H7493942820350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 20 mm synergy megatron drug-eluting stent (des) was selected for treatment.However, during insertion, the shaft of the delivery system broke between the physician's fingers.The physician was able to remove and retrieve the stent before it was deployed.A new 3.5 x 20 mm synergy megatron des was then used and successfully implanted.The procedure was completed with another stent of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy megatron mr us 3.50 x 20mm was returned for analysis.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft and a shaft break 56cm distal to the distal end of the strain relief.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A microscopic analysis identified there was no sign of damage, stretching or lifting of the stent struts.A microscopic examination of the balloon identified no damages.The balloon was tightly folded and did not appear to have been subjected to any positive pressure.Bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 20 mm synergy megatron drug-eluting stent (des) was selected for treatment.However, during insertion, the shaft of the delivery system broke between the physician's fingers.The physician was able to remove and retrieve the stent before it was deployed.A new 3.5 x 20 mm synergy megatron des was then used and successfully implanted.The procedure was completed with another stent of the same device.No patient complications were reported.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20783633
• Report Number: 2124215-2024-74529
• Device Sequence Number: 5004503
• Product Code: NIQ
• UDI-Device Identifier: 08714729985655
• UDI-Public: 08714729985655
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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): 03/11/2025

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: 11/05/2025
• Device Model Number: H7493942820350
• Device Catalogue Number: H7493942820350
• Device Lot Number: 0032857586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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
• Patient Sex: Unknown