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

Model Number	H7493942812500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the renal artery.A 5.00 x 12mm synergy megatron drug-eluting stent was advanced for treatment.However, it was noted that the device broke in two pieces.The device was removed together with the guide catheter with no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the renal artery.A 5.00 x 12mm synergy megatron drug-eluting stent was advanced for treatment.However, it was noted that the device broke in two pieces.The device was removed together with the guide catheter with no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a synergy megatron mr us 5.00 x 12mm stent delivery system (sds) catheter was returned to the complaint investigation site (cis).Visual, tactile and microscopic analysis and functional testing was performed on the device.No issues identified with the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion identified a break in the midshaft approximately 35cm from the distal tip and stretching of the distal shaft at the port exchange.A microscopic inspection noted that the inner lumen was bunched 5.8cm from the distal tip.Microscopic analysis found blood inside the balloon.There was no stent attached to the device and the detached stent was not returned for analysis.Bumper tip showed no signs of distal tip damage.Functional testing identified traces of blood inside the balloon however it was not possible to inflate the balloon due to the extent of the damage.

• 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: 20657324
• Report Number: 2124215-2024-70779
• Device Sequence Number: 7914365
• Product Code: NIQ
• UDI-Device Identifier: 08714729985600
• UDI-Public: 08714729985600
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 07/02/2025
• Device Model Number: H7493942812500
• Device Catalogue Number: H7493942812500
• Device Lot Number: 0032097267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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