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

Model Number	H7493942808500
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties and balloon deflation failure occurred.The chronic totally occluded target lesion was located in the left main artery.A 5.00 x 8mm synergy megatron drug-eluting stent (des) and a 5.00x16 synergy megatron des were deployed for treatment.However, it was noted that the stent balloons were sticky and stuck in the lesion where the stents were implanted.It was also noted that the balloons were not deflating properly and one of the balloons got stuck and could not pass through the guide catheter.The physician had to pull negative and deflate the balloons multiple times and had to take the balloons and guide catheter system out, as a whole unit.Both stents were implanted into the patient and the procedure was completed.No harm was caused to the patient.
Event or Problem Description
It was reported that removal difficulties and balloon deflation failure occurred.The chronic totally occluded target lesion was located in the left main artery.A 5.00 x 8mm synergy megatron drug-eluting stent (des) and a 5.00x16 synergy megatron des were deployed for treatment.However, it was noted that the stent balloons were sticky and stuck in the lesion where the stents were implanted.It was also noted that the balloons were not deflating properly and one of the balloons got stuck and could not pass through the guide catheter.The physician had to pull negative and deflate the balloons multiple times and had to take the balloons and guide catheter system out, as a whole unit.Both stents were implanted into the patient and the procedure was completed.No harm was caused to the patient.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy megatron mr us 5.00 x 8mm stent delivery system was returned for analysis.The device was returned inside the guide catheter with no stent attached and the balloon in a deflated state.Numerous kinks observed on the guide catheter.Device soaked overnight in the waterbath at 37 degrees.No stent was returned.The balloon was in a deflated state with no signs of visual damage.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.The balloon was inflated to 16atm, the device inflated, held pressure and deflated after 15s which is inside the deflation time of 30s.The device was removed through guide catheter without issues.

• 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: 16137341
• Report Number: 2124215-2022-56446
• Device Sequence Number: 12414756
• Product Code: NIQ
• UDI-Device Identifier: 08714729985563
• UDI-Public: 08714729985563
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 02/08/2023

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: 02/07/2023
• Device Model Number: H7493942808500
• Device Lot Number: 0028887982
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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: Male