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

Lot Number	0031838065
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty and balloon detachment occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified vessel.A 5.00 x 32mm synergy megatron was advanced for treatment and deployed.The balloon was fully deflated.However, during the procedure, even though the balloon was fully deflated, the physician had difficulty removing the balloon.When the balloon was pulled back, the balloon was partially detached from the shaft.The stent balloon, wire, and guide catheter had to be removed as one unit.The procedure was completed with no patient complications were reported.
Additional Manufacturer Narrative
The device was returned for analysis.A visual and tactile examination of the balloon identified that the balloon was creased and there was some blood visible inside the balloon.The stent was not received for analysis.The tip section of the device was lightly inverted into the distal end of the balloon.A visual, tactile and microscopic examination identified multiple kinking along the hypotube.The device was received in two sections as a result of a break in the midshaft extrusion at the guidewire exit port.The distal extrusion identified that the extrusion was severely stretched and necked down along both sections of the break.A microscopic examination of the balloon material identified no tears or holes in the balloon.However, there was a large build-up of solidified blood inside the balloon.Due to the condition of the returned device, it was not possible to inflate the balloon in order to test inflate/deflate functionality.A microscopic examination of the tip identified no damages.The balloon was extending towards the tip which was inverting the tip into the distal end of the balloon.
Event or Problem Description
It was reported that removal difficulty and balloon detachment occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified vessel.A 5.00 x 32mm synergy megatron was advanced for treatment and deployed.The balloon was fully deflated.However, during the procedure, even though the balloon was fully deflated, the physician had difficulty removing the balloon.When the balloon was pulled back, the balloon was partially detached from the shaft.The stent balloon, wire, and guide catheter had to be removed as one unit.The procedure was completed with no patient complications were reported.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19102407
• Report Number: 2124215-2024-22040
• Device Sequence Number: 12619381
• Product Code: NIQ
• UDI-Device Identifier: 08714729985808
• UDI-Public: 08714729985808
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/14/2024

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: 05/22/2024
• Device Lot Number: 0031838065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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
• Patient Sex: Unknown