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

Model Number	H7493942820350
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the day of the event is unknown.Boston scientific became aware of the event on (b)(6) 2021.Therefore, a date of (b)(6) 2021 was entered to indicate that the event occurred on an unknown day in august 2021.
Event or Problem Description
It was reported that stent damage occurred.A 3.50 x 20mm synergy megatron stent was advanced to the target lesion, but the stent could not cross, and the struts of the stent broke.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient was stable following the procedure.
Additional Manufacturer Narrative
B3: date of event: the day of the event is unknown.Boston scientific became aware of the event on 01 aug 2021.Therefore, a date of 01 aug 2021 was entered to indicate that the event occurred on an unknown day in (b)(6) 2021.Device evaluated by mfr: a 3.50 x 20mm synergy megatron stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage with struts on the midsection in a lifted state.The undamaged crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement specification.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.A visual and microscopic examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.A 3.50 x 20mm synergy megatron stent was advanced to the target lesion, but the stent could not cross, and the struts of the stent broke.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient was stable following the procedure.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12416177
• Report Number: 2134265-2021-11134
• Device Sequence Number: 4724268
• Product Code: NIQ
• UDI-Device Identifier: 08714729985655
• UDI-Public: 08714729985655
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: 12/02/2021
• Device Model Number: H7493942820350
• Device Lot Number: 0026495670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1