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

Model Number	H7493942812450
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target vessel was located in the moderately calcified and mildly tortuous left main artery.A 4.5mm x 12mm synergy megatron drug-eluting stent was successfully implanted, however, the stent delivery system was difficult to remove from the stent.Forceful removal was required and the catheter fractured.An attempt to remove the fractured catheter via snare was unsuccessful and the device had to be removed by a vascular surgeon using a cutdown of the brachial artery.The procedure was completed successfully.Hospital admission beyond standard of care was required, however, the patient is fully recovered.There were no further complications reported.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target vessel was located in the moderately calcified and mildly tortuous left main artery.A 4.5mm x 12mm synergy megatron drug-eluting stent was successfully implanted, however, the stent delivery system was difficult to remove from the stent.Forceful removal was required and the catheter fractured.An attempt to remove the fractured catheter via snare was unsuccessful and the device had to be removed by a vascular surgeon using a cutdown of the brachial artery.The procedure was completed successfully.Hospital admission beyond standard of care was required, however, the patient is fully recovered.There were no further complications reported.It was further reported that the post deployment, balloon was inflated three times.A few seconds were waited for balloon deflation before pulling back the device.It was confirmed under fluoroscopy that the all the contrast had left the balloon prior to the withdrawal attempt.A 6f guide catheter was used during the procedure.No significant angulation or unusual take off was present.It was noted that the balloon would not come out of the stent.There was no difficulty advancing or positioning the stent at the lesion site.No other device was present in the vessel.The device could not maintain pressure, and no gradual loss of pressure was noted in the inflation device.No leaks were noted from the shaft of the device.No further patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluated by mfr: a 4.50 x 12 mm synergy megatron mr tent delivery system (sds), was returned without the distal section of the device containing the inner/outer shaft polymer extrusion, balloon and tip.The device was returned without the distal shaft containing the stent.Distal shaft of the device not returned so the balloon cones could not be reviewed.Distal shaft of the device not returned so the tip of the device could not be reviewed.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found a break in the midshaft region at 119 cm distal to the distal end of the strain relief with the corewire exposed.No other issues were identified during analysis.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15106088
• Report Number: 2134265-2022-08173
• Device Sequence Number: 11799792
• Product Code: NIQ
• UDI-Device Identifier: 08714729985594
• UDI-Public: 08714729985594
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/15/2022

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: 08/12/2022
• Device Model Number: H7493942812450
• Device Lot Number: 0027874923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female