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

Model Number	H7493942816500
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties and stent damage post deployment occurred.The 80-95% stenosed target lesion was located in mild-non tortuous and moderately calcified left main artery.Intravenous ultrasound (ivus) was done, and pre-dilatation was performed of the target lesion.A 5.00 x 16mm synergy megatron stent was unpacked and prepped with one negative prep.The synergy megatron stent was then advanced for treatment and few angiographies was done to confirm proper position.The physician inflated the device with a 70 saline and 30 contrast mixture to 16 atmospheres (atms) for 25 seconds and dialed down the atms for 5-10 seconds to zero and pulled negative.During removal of the stent delivery system (sds) with inflation device on negative, the sds would not pass through the 7fr.Non- boston scientific guide catheter and it was stuck.The physician tried to lightly tug on the sds system to release and the balloon would not retract into the guide catheter.The balloon of the sds was tried to inflate to 3-6 atm and slowly came down but still the balloon did not wrap well as well as retract into the guide.The physician then removed the entire guide catheter, samurai wire, and sds from the groin sheath.However, it was noted that the ostial part of the stent was deformed due to the sds balloon getting stuck and unable to remove from the guide.The physician re-wired the coronary artery and deploy a 5.0x 12mm synergy xd stent to cover the deformation of the megatron stent and the procedure was completed.There were no patient complications nor injuries reported.

• 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: 15691945
• Report Number: 2124215-2022-43584
• Device Sequence Number: 15293525
• Product Code: NIQ
• UDI-Device Identifier: 08714729985648
• UDI-Public: 08714729985648
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/28/2022

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: 05/31/2023
• Device Model Number: H7493942816500
• Device Lot Number: 0029567499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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: Male