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

Model Number H7493942812450

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that difficult to remove a balloon occurred.A 100% stenosed target lesion was located in the none tortuous and mildly calcified left main artery.A 4.50 x 12mm synergy megatron stent was selected for percutaneous coronary intervention (pci) procedure.The device was advanced to the target lesion and deployed without any problems.The stent was deployed at 11 atmospheres with no issues encountered.The stent was post dilated at 16 atmospheres.While withdrawing balloon into the guide catheter, resistance occurred.After several attempts to deflate the megatron stent balloon, the balloon became lodged in the non-boston scientific guide catheter and it would not come out.The balloon was fully deflated , the physician removed the guide catheter and the stent balloon as one piece by pulling the guide catheter with it.The procedure was completed successfully with another guide catheter.There were no patient complications and the patient was stable post procedure with successful outcome.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13006773
• MDR Text Key: 282334253
• Report Number: 2134265-2021-15691
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985594
• UDI-Public: 08714729985594
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2022
• Device Model Number: H7493942812450
• Device Lot Number: 0027253276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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
• Treatment: 6F EBU GUIDE CATHETER - MEDTRONIC
• Patient Sex: Female