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

Model Number	H7493942812450
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent delivery system removal difficulties occurred.The target lesion was located in the proximal left anterior descending (lad) artery.A 4.50 x 12mm synergy megatron drug-eluting stent was advanced and successfully implanted in the lesion.However, the physician struggled to remove the stent delivery system (sds) from the freshly deployed stent.It was noticed that the distal plastic of the shaft was stretched and became elongated during the removal.The sds was able to remove intact after exerting significant and more withdrawal force and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy megatron mr us 4.50 x 12mm stent delivery system, catheter was returned for analysis.No stent was returned; the stent was implanted in the patient.The balloon cones were reviewed, and the balloon was in a deflated, bunched state.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 multiple kinks and stretching damages of the shaft polymer extrusion.No other issues were identified during analysis.
Event or Problem Description
It was reported that stent delivery system removal difficulties occurred.The target lesion was located in the proximal left anterior descending (lad) artery.A 4.50 x 12mm synergy megatron drug-eluting stent was advanced and successfully implanted in the lesion.However, the physician struggled to remove the stent delivery system (sds) from the freshly deployed stent.It was noticed that the distal plastic of the shaft was stretched and became elongated during the removal.The sds was able to remove intact after exerting significant and more withdrawal force and the procedure was completed.There were no patient complications 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16724185
• Report Number: 2124215-2023-14633
• Device Sequence Number: 7949918
• Product Code: NIQ
• UDI-Device Identifier: 08714729985594
• UDI-Public: 08714729985594
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 11/07/2023
• Device Model Number: H7493942812450
• Device Lot Number: 0030595032
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INFLATION DEVICE: MERIT
• Patient Sex: Unknown