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

Model Number H7493942832500

Device Problems Difficult to Remove (1528); Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2023

Event Type  malfunction  

Event Description

It was reported that deflation issue and removal difficulties were encountered.The patient presented with coronary artery disease (cad).The target lesion was located in right coronary artery.A boston scientific inflation device was used during the procedure with the saline contrast ratio of 50/50.A 5.00 x 32mm synergy megatron drug-eluting stent (des) was advanced and implanted.However, during the procedure, the balloon would not deflate well, and was difficult to track back through the guide.Another 5.00 x 20mm synergy megatron des was implanted; but same issue was encountered.The first balloon was able to be removed and the second balloon had to be removed with the guide and the wire.The vessel was reselected and re-wired to post dilate the lesion with a 5.5x15 nc emerge balloon catheter which had no issues in deflating.The procedure was completed successfully, and no patient complications were reported.The patient condition was stable.

• Brand Name: SYNERGY MEGATRON
• Type of Device: 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: 16600272
• MDR Text Key: 311865970
• Report Number: 2124215-2023-12918
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985808
• UDI-Public: 08714729985808
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2023
• Device Model Number: H7493942832500
• Device Lot Number: 0030473091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1