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

Model Number H7493941832300

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2021

Event Type  malfunction  

Event Description

During a multivessel percutaneous coronary intervention (pci) with the assistance of an impella.The initial undeployed lad stent came off the balloon in the left main and had to be removed with a 6f guideliner.During removal of the lad stent, the initial wiring of the lad stent was threaded through a strut on the lcx stent, which resulted in unintended removal of the lcx stent.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12312160
• MDR Text Key: 266205806
• Report Number: 12312160
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493941832300
• Device Catalogue Number: H7493941832300
• Device Lot Number: 26820399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2021
• Date Report to Manufacturer: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31755 DA