• 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 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 CORONARY DRUG-ELUTING STENT Back to Search Results
Catalog Number H7493926028250
Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)
Patient Problem Failure of Implant (1924)
Event Date 05/07/2019
Event Type  Malfunction  
Event Description

Because of persistent stenosis in the obtuse marginal was previously dilated physician attempted to pass a 2. 25 x 12 mm synergy drug-eluting stent into the obtuse marginal to overlap with the previously placed stent. There was considerable difficulty despite guide and guide liner support. Several different configurations of wire and guide liner support were attempted to deliver the stent. The stent was being removed and there was considerable difficulty to return the stent delivery system into the guide. When the stent delivery was removed there was evidence of loss of stent. On fluoroscopy the undeployed stent was in the proximal circumflex. During removal of the stent delivery there was inadvertent removal of the wire from the circumflex and the undeployed stent. The physician initially attempted to wire into the circumflex with a plan of stenting the undeployed stent against the wall. Several wires were attempted unsuccessfully. It would not traverse the proximal vessel because of the tortuosity and now the undeployed stent reflecting the wire tip. When we rotated views to help with facilitation of wire passage it became obvious that the proximal portion of the stent had recoiled into the lad. This meant the stent was laying perpendicular to the left main with a portion in the lad and the majority in the proximal circumflex. Given this complex configuration it was obvious the stent would not be able to be rewired or removed with a retrieval device. The options of bifurcational left main stenting or single stenting of the lad into the left main were considered but given this patient's known occlusion of the rca vessel placement in increased risk of adverse events. The physician elected at that time to discontinue the intervention to discuss the options with thoracic surgery.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9097553
MDR Text Key159363740
Report Number9097553
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/20/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberH7493926028250
Device LOT Number23045936
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/15/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/16/2019
Event Location Hospital
Date Report TO Manufacturer09/20/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-