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

Model Number	H7493942812450
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that difficult to remove a balloon occurred.A 100% stenosed target lesion was located in the none tortuous and mildly calcified left main artery.A 4.50 x 12mm synergy megatron stent was selected for percutaneous coronary intervention (pci) procedure.The device was advanced to the target lesion and deployed without any problems.The stent was deployed at 11 atmospheres with no issues encountered.The stent was post dilated at 16 atmospheres.While withdrawing balloon into the guide catheter, resistance occurred.After several attempts to deflate the megatron stent balloon, the balloon became lodged in the non-boston scientific guide catheter and it would not come out.The balloon was fully deflated , the physician removed the guide catheter and the stent balloon as one piece by pulling the guide catheter with it.The procedure was completed successfully with another guide catheter.There were no patient complications and the patient was stable post procedure with successful outcome.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13006773
• Report Number: 2134265-2021-15691
• Device Sequence Number: 13884922
• Product Code: NIQ
• UDI-Device Identifier: 08714729985594
• UDI-Public: 08714729985594
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/14/2021

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: 04/22/2022
• Device Model Number: H7493942812450
• Device Lot Number: 0027253276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F EBU GUIDE CATHETER - MEDTRONIC
• Patient Sex: Female