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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Cardiac Tamponade (2226)

Event Date 12/20/2022

Event Type  Death  

Event Description

It was reported that a cardiac tamponade and death occurred.Rotablation was successfully performed in the left circumflex (lcx) with a rotablator.After rotablation, the lesion was treated with a balloon and intravascular ultrasonography (ivus) from the mid lcx back to left main (lm).Based on the calcified lesion and location of calcium/plaque at the ostium, a stent was used from the mid lcx to lm.A 4.00 x 24mm synergy megatron stent was deployed successfully with no dissections or issues.The stent was post dilated in the distal and mid part of the stent with a 4.0 nc balloon.The physician then proceeded to post dilate the proximal with a 5.0 balloon.The lm measured 5.7 - 6mm with ivus.After ballooning the left main with the 5.0 balloon, a large lm perforation was present, and a cardiac tamponade occurred.Balloon tamponade was performed, and a code was run until the patient eventually passed.The official cause of death was perforation, shock, and coronary artery disease (cad).

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16137275
• MDR Text Key: 307080434
• Report Number: 2124215-2022-56271
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/11/2023
• 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
• Treatment: APEX BALLOONS - BOSTON SCIENTIFIC; ROTABLATOR - BOSTON SCIENTIFIC
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 90 YR
• Patient Sex: Female