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

Lot Number	0032134034
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 3.50 x 32mm synergy megatron drug-eluting stent was advanced for treatment.However, during the procedure, the stent catheter was broken.The device was removed completely intact from the patient, and the procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 3.50 x 32mm synergy megatron drug-eluting stent was advanced for treatment.However, during the procedure, the stent catheter was broken.The device was removed completely intact from the patient, and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy megatron mr us 3.50 x 32mm was returned to the complaint investigation site (cis).A visual, tactile and microscopic examination of the hypotube shaft identified a break in the device at 25.8cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.There was no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Bumper tip showed signs of distal tip damage (flared).

• 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: 18764021
• Report Number: 2124215-2024-10550
• Device Sequence Number: 11887043
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: 08714729985778
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• 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): 03/28/2024

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: 07/16/2025
• Device Lot Number: 0032134034
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• 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 Age: 80 YR
• Patient Sex: Male