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

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported the removal difficulties occurred.A percutaneous coronary intervention was being performed.The target lesion was located in the right coronary artery.This synergy megatron stent balloon expandable device along with a 6fr convey guide catheter were selected.During withdrawal of the synergy megatron resistance was met at the distal end of the guide cather and the synergy megatron was not able to come inside the guide catheter.No patient complications were reported.

Event Description

It was reported the removal difficulties occurred.A percutaneous coronary intervention was being performed.The target lesion was located in the right coronary artery.This synergy megatron stent balloon expandable device along with a 6fr convey guide catheter were selected.During withdrawal of the synergy megatron resistance was met at the distal end of the guide cather and the synergy megatron was not able to come inside the guide catheter.No patient complications were reported.

Manufacturer Narrative

D4: unique identifier (udi) #: updated.E1: initial reporter address 1: (b)(6).

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10553845
• MDR Text Key: 207539038
• Report Number: 2134265-2020-12965
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/21/2020
• Patient Sequence Number: 1
• Treatment: 6FR CONVEY GUIDE CATHETER; 6FR CONVEY GUIDE CATHETER; 6FR CONVEY GUIDE CATHETER