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

Device Problems Deflation Problem (1149); Device-Device Incompatibility (2919)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that balloon deflation issues occurred and the balloon was stuck in the catheter.A 5.00 x 20mm synergy megatron stent balloon expandable was advanced for treatment of moderately calcified and mild tortuous lesion.During the procedure a 5.00 x 20mm synergy megatron stent was implanted.Following implantation, the delivery balloon was attempted to be deflated four times, however the balloon did not fully deflate and remained stuck in the non-bsc catheter.The entire catheter was removed, and the procedure was completed successfully.There were no patient complications reported.

Manufacturer Narrative

Device media review: received attached to this complaint were two photo images.These images appear to show that the guide catheter has been dissected in order to expose the balloon.No tears or damages are noted in the balloon material.The balloon appears deflated.

Event Description

It was reported that balloon deflation issues occurred and the balloon was stuck in the catheter.A 5.00 x 20mm synergy megatron stent balloon expandable was advanced for treatment of moderately calcified and mild tortuous lesion.During the procedure a 5.00 x 20mm synergy megatron stent was implanted.Following implantation, the delivery balloon was attempted to be deflated four times, however the balloon did not fully deflate and remained stuck in the catheter.The entire catheter was removed, and the procedure was completed successfully.There were no patient complications reported.It was further reported that 6fr catheter used was a non-bsc (medtronic) catheter.The physician deflated the balloon 3 times, waiting for approximately 20-30 seconds before attempting to withdraw the device each time.

Event Description

It was reported that balloon deflation issues occurred and the balloon was stuck in the catheter.A 5.00 x 20mm synergy megatron stent balloon expandable was advanced for treatment of moderately calcified and mild tortuous lesion.During the procedure a 5.00 x 20mm synergy megatron stent was implanted.Following implantation, the delivery balloon was attempted to be deflated four times, however the balloon did not fully deflate and remained stuck in the non-bsc catheter.The entire catheter was removed, and the procedure was completed successfully.There were no patient complications reported.It was further reported that 6fr catheter used was a non-bsc (medtronic) catheter.The physician deflated the balloon 3 times, waiting for approximately 20-30 seconds before attempting to withdraw the device each time.

Manufacturer Narrative

B3 date of event: updated, as the event date was not reported, the first day in the month of the aware date is provided b5-describe event or problem: updated c2/d10-concomitant product/therapy: updated.

• 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 IRELAND LIMITED; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18619317
• MDR Text Key: 334283148
• Report Number: 2124215-2024-02973
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 01/22/2024; 03/05/2024
• Supplement Dates FDA Received: 02/14/2024; 03/26/2024
• 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
• Treatment: GUIDE CATHETER, MEDTRONIC.; GUIDE CATHETER, MEDTRONIC.