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

Model Number	H7493942812500
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	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation and removal difficulties occurred.The 95% stenosed target lesion was located in a moderately calcified non tortuous proximal circumflex artery.A synergy megatron 5.00 x 12mm balloon expandable stent was successfully deployed into the lesion.The stent delivery balloon was deflated to zero for 20-30 seconds then pulled negative on the inflation device.The stent delivery system could not be removed from the guide catheter.The wire, stent delivery system and guide catheter were removed as one unit.The balloon was not completely deflated and too big to removed from the guide catheter.No patient complications were reported.
Event or Problem Description
It was reported that balloon deflation and removal difficulties occurred.The 95% stenosed target lesion was located in a moderately calcified non tortuous proximal circumflex artery.A synergy megatron 5.00 x 12mm balloon expandable stent was successfully deployed into the lesion.The stent delivery balloon was deflated to zero for 20-30 seconds then pulled negative on the inflation device.The stent delivery system could not be removed from the guide catheter.The wire, stent delivery system and guide catheter were removed as one unit.The balloon was not completely deflated and too big to removed from the guide catheter.No patient complications were reported.
Additional Manufacturer Narrative
Analysis of device by mfr: synergy megatron mr us 5.00 x 12mm stent delivery system (sds) was returned for analysis.The following attributes were examined: an incomplete device was returned for analysis.The shaft of the device was found to be broken in the shaft polymer extrusion region with no hypotube or hub portion of the device returned for analysis.The portion of the device returned, from distal tip to the break site measured 12.5 cm.Balloon: balloon was found to be in a deflated state and bunched.No stent was present as this was successfully deployed during the procedure.Functional testing could not be completed due to the proximal section of the device not being returned.

• 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: 15544408
• Report Number: 2124215-2022-39828
• Device Sequence Number: 5862467
• Product Code: NIQ
• UDI-Device Identifier: 08714729985600
• UDI-Public: 08714729985600
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 11/22/2022

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: 01/17/2023
• Device Model Number: H7493942812500
• Device Lot Number: 0028774783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White