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

Lot Number	0031200262
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.The target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.The lesion was prepared using a 1.75 mm rotapro burr followed by a 6.00 mm non-compliant balloon.A 5.00 x 32 mm synergy megatron was deployed and upon removal the shaft broke 11 cm from the distal tip.The balloon with a portion of the shaft was left in the body.The physician attempted to remove the device fragment with a guidezilla unsuccessfully.A snare was used to retrieve the remaining piece of the device and the procedure was completed.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.The target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.The lesion was prepared using a 1.75 mm rotapro burr followed by a 6.00 mm non-compliant balloon.A 5.00 x 32 mm synergy megatron was deployed and upon removal the shaft broke 11 cm from the distal tip.The balloon with a portion of the shaft was left in the body.The physician attempted to remove the device fragment with a guidezilla unsuccessfully.A snare was used to retrieve the remaining piece of the device and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy megatron mr us 5.00 x 32mm was returned for analysis.Visual, tactile, and microscopic analysis were performed on the device.Device analysis found that the stent was not attached and not returned, stent was deployed.The balloon was in a deflated state.Multiple kinks were found along the hypotube shaft and a polymer extrusion shaft break at 123cm distal to the distal end of the strain relief.No other device issues were identified during the returned product 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18145656
• Report Number: 2124215-2023-64451
• Device Sequence Number: 20718019
• Product Code: NIQ
• UDI-Device Identifier: 08714729985808
• UDI-Public: 08714729985808
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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
• Report Date (Section B): 01/10/2024

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: 02/28/2024
• Device Lot Number: 0031200262
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown