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

Lot Number	0032134034
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred which required additional intervention.The target lesion was located in the moderately tortuous and mildly calcified mid to proximal left anterior descending artery (lad).A 3.50 x 32mm synergy megatron drug eluting stent was advanced for dilation.The stent shaft was bent while loading onto the wire down into the lad.The shaft broke while advancing the device through the guide.The stent and delivery system exited the guide, but the distal portion of the stent delivery system was within the guide.The physician used a small balloon to track beyond the stent and inflated it to pull back the stent delivery system.Once the balloon was inflated and pulled, the physician was able to remove the stent and the stent delivery system through the guide.The physician rewired the lad and continued the procedure, placing a 3.5 x 38mm synergy stent in the diseased portion and the procedure was completed successfully.No patient complications were reported as a results of this event.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy megatron mr us 3.50 x 32mm stent delivery system (sds) was returned for analysis.Visual, tactile and microscopic inspection of the hypotube shaft identified a break at 81cm distal to the distal end of the strain relief.Also, multiple hypotube kinks were identified in various locations along the length of the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic analysis revealed that there was no sign of damage, stretching or lifting of the stent struts.There were no signs of movement, the stent was set between the proximal and distal markerbands.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred which required additional intervention.The target lesion was located in the moderately tortuous and mildly calcified mid to proximal left anterior descending artery (lad).A 3.50 x 32mm synergy megatron drug eluting stent was advanced for dilation.The stent shaft was bent while loading onto the wire down into the lad.The shaft broke while advancing the device through the guide.The stent and delivery system exited the guide, but the distal portion of the stent delivery system was within the guide.The physician used a small balloon to track beyond the stent and inflated it to pull back the stent delivery system.Once the balloon was inflated and pulled, the physician was able to remove the stent and the stent delivery system through the guide.The physician rewired the lad and continued the procedure, placing a 3.5 x 38mm synergy stent in the diseased portion and the procedure was completed successfully.No patient complications were reported as a results of this event.

• 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: 18988903
• Report Number: 2124215-2024-14679
• Device Sequence Number: 2857857
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: 08714729985778
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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: 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): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown