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

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 09/15/2023

Event Type  malfunction  

Event Description

It was reported that catheter entrapment and removal difficulties occurred.The target lesion was located in the non-tortuous and non-calcified vessel.A 5.00 x 12mm synergy megatron drug-eluting stent (des) was advanced for treatment.The physician inserted the megatron device to the guide catheter, and when the balloon was inflated, it got stuck to the stent.They managed to release but was concerned that the stent might dislodged.When they tried to remove the balloon through the catheter, it failed.Subsequently, he removed it and the catheter as one unit.A kinked on the mid shaft was noticed.The procedure was completed successfully with no patient complications were reported.

• Brand Name: SYNERGY MEGATRON
• Type of Device: 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: 17940788
• MDR Text Key: 325834102
• Report Number: 2124215-2023-55546
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 10/16/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 76 YR
• Patient Sex: Male