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

Model Number	H7493942816400
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties occurred.The 80% stenosed target lesion was located in a non-tortuous and non-calcified coronary artery.A 4.00 x 16mm synergy megatron drug-eluting stent was advanced for treatment.However, after successfully deploying the stent, the physician experienced a hard time removing the balloon in the guide catheter.The balloon was reinflated and deflated again, but rewrap failed.The device was removed from the patient intact as a whole unit and the procedure was successfully completed with another device.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties occurred.The 80% stenosed target lesion was located in a non-tortuous and non-calcified coronary artery.A 4.00 x 16mm synergy megatron drug-eluting stent was advanced for treatment.However, after successfully deploying the stent, the physician experienced a hard time removing the balloon in the guide catheter.The balloon was reinflated and deflated again, but rewrap failed.The device was removed from the patient intact as a whole unit and the procedure was successfully completed with another device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the synergy megatron mr us 4.00 x 16mm was returned for analysis.Visual and tactile inspection revealed the device was received inserted through the guide catheter.A visual and tactile examination identified multiple kinking along the exposed section of the hypotube, exiting from the guide catheter.No kinks or damages with shaft polymer extrusion.A visual examination of the balloon section of the device, which was exiting the guide catheter, identified no damage.The balloon was not folded and did not appear fully deflated.A detailed microscopic examination of the balloon material identified no damages.Microscopic analysis revealed the balloon exhibited signs of having been inflated and was not refolded and fully deflated.No issues identified during examination of the extrusion shaft, after the device was removed from the guide.A microscopic examination of the tip section found that tip was compressed.An initial attempt to withdraw the device back through the guide met with a restriction when an attempt was made to pull the balloon section back through the guide.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure of 16 atmospheres with no leaks noted.A vacuum was applied to the balloon and the balloon was allowed to deflate for 30 seconds.Although the balloon did not refold correctly, the balloon folds did tighten, and it was possible to remove the device from the guide catheter with no resistance noted.

• 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: 17043768
• Report Number: 2124215-2023-25562
• Device Sequence Number: 13026257
• Product Code: NIQ
• UDI-Device Identifier: 08714729985624
• UDI-Public: 08714729985624
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 07/06/2023
• Device Model Number: H7493942816400
• Device Lot Number: 0029778931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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
• Patient Sex: Unknown