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

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.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9097553
• MDR Text Key: 159363740
• Report Number: 9097553
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H7493926028250
• Device Lot Number: 23045936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 70