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

Model Number H7493942816450

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

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

It was reported that catheter entrapment and removal difficulties occurred.The patient was presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.50 x 16mm synergy megatron drug-eluting stent was advanced for treatment.After stent deployment, the stent balloon was deflated but removal difficulty was encountered.The distal portion of the balloon was prolapsed and was stuck on the guide catheter despite multiple negative pressure pulls on the balloon port.Finally, the entire system was removed, and a new guide catheter, guidewire, and balloon were reintroduced for post-dilatation to complete the procedure.There were no patient complications nor injuries were reported.

Manufacturer Narrative

H6 device codes: corrected.

Event Description

It was reported that catheter entrapment and removal difficulties occurred.The patient was presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.50 x 16mm synergy megatron drug-eluting stent was advanced for treatment.After stent deployment, the stent balloon was deflated but removal difficulty was encountered.The distal portion of the balloon was prolapsed and was stuck on the guide catheter despite multiple negative pressure pulls on the balloon port.Finally, the entire system was removed, and a new guide catheter, guidewire, and balloon were reintroduced for post-dilatation to complete the procedure.There were no patient complications nor injuries were reported.It was further reported that vascular access was obtained via right radial artery.The target lesion was located in proximal right coronary artery.A 6 french fr4 runway guide catheter was engaged during the procedure.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16715843
• MDR Text Key: 313054521
• Report Number: 2124215-2023-16889
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985631
• UDI-Public: 08714729985631
• 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,Followup
• Report Date: 05/01/2023

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: 07/06/2023
• Device Model Number: H7493942816450
• Device Lot Number: 0029787355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 84 KG