Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0024235175
Device Problems Difficult to Remove (1528); Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that difficulty removing a stent device and a tear occurred.The target lesion was located in the moderately calcified and mildly tortuous ostial right coronary artery (rca).A 4.00 x 12mm synergy megatron stent balloon was advanced and successfully deployed in the ostial rca.A stent balloon was used to post dilate the stent at 24 bar.Post dilatation, the stent delivery system (sds) was pulled into the guide catheter.Once the distal part of the sds was completely in the 6f guide catheter, resistance was felt.In response to the resistance, the device was pulled on harder which resulted in a rip somewhere on the sds.The difficulty removing and rip occurred within the guide catheter and therefore the complete system (sds and guide) were safely taken out of the patient.It was noted that the reason for the difficulty removing the device and balloon was likely due to dilating the balloon at 24 bar.No patient complications resulted from this event and the patient was reported to be stable following the procedure.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: synergy megatron mr ous 4.00 x 12mm stent delivery system (sds) was returned for analysis, broken into 2 sections and without a stent.An examination found that the balloon appeared to have been subjected to positive and negative pressure.Some bunching of balloon material at proximal end.No visible issues with proximal bond.A visual via scope and tactile examination of the shaft polymer was carried out.A break was identified in the mid shaft extrusion 122mm distal of distal end of strain relief (on the proximal side of the port bond).Stretching of the mid shaft was noted on both sides of the break site.Some stretching also noted on the distal side of the port bond (distal shaft).The break exposed the corewire and separated the distal section.Damage was noted to the distal inner (blue section), it was bunched/accordioned, from 2 to 4mm distal of the bicomponent bond.A visual via scope examination of the tip identified tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual via scope examination of the manifold and strain relief did not identify any visible issues.The proximal end of the hypotube was looked down into via scope an no visible blockages were evident.An attempt was made to load the distal section over a 0.014 inch guidewire via tip, the wire was blocked at tip by what appeared to be dried media in the tip.The distal section was placed in small zip lock bag and placed in water batch to soak at 37 degrees to soften dried media.The device was removed from water bath after soaking overnight and second attempt was made to load the wire.The distal section of device was loaded and tracked over wire with some resistance noted, a white substance, appeared to be contract media came out of the wire lumen when tracking the wire.Wire was loaded via tip and exited at the wire exchange port.No other issues were noted.
 
Event Description
It was reported that difficulty removing a stent device and a tear occurred.The target lesion was located in the moderately calcified and mildly tortuous ostial right coronary artery (rca).A 4.00 x 12mm synergy megatron stent balloon was advanced and successfully deployed in the ostial rca.A stent balloon was used to post dilate the stent at 24 bar.Post dilatation, the stent delivery system (sds) was pulled into the guide catheter.Once the distal part of the sds was completely in the 6f guide catheter, resistance was felt.In response to the resistance, the device was pulled on harder which resulted in a rip somewhere on the sds.The difficulty removing and rip occurred within the guide catheter and therefore the complete system (sds and guide) were safely taken out of the patient.It was noted that the reason for the difficulty removing the device and balloon was likely due to dilating the balloon at 24 bar.No patient complications resulted from this event and the patient was reported to be stable following the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9291576
MDR Text Key170118237
Report Number2134265-2019-13471
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0024235175
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Date Manufacturer Received11/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-