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

Model Number 10619

Device Problems Break (1069); Positioning Failure (1158); Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Ischemia (1942); Ventricular Fibrillation (2130); Foreign Body In Patient (2687)

Event Date 12/09/2021

Event Type  Injury  

Event Description

It was reported that a shaft break and stent dislodged occurred. A percutaneous coronary intervention was performed during an acute myocardial infarction, with injury to the proximal and middle anterior descending artery. Following predilation with a balloon, a 3. 50 x 20 synergy stent was advanced to the target lesion, with an attempt to deploy, but the balloon would not inflate. It was noted that with the impossibility of inflating the stent, it was not possible to raise the pressure. At that time, the manometer was exchanged, and was unable to inflate, and so it was decided to remove the stent device. While removing the stent device, the hypotube fractured at the level of the balloon and the stent, extracting only the rest of the hypotube, which complicated the procedure. The balloon coiled and the stent remained in the distal segment of the distal anterior descending artery, causing no reflow and cardiac arrest due to ventricular fibrillation. No further patient complications were reported in relation to this event.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13018166
• MDR Text Key: 282333083
• Report Number: 2134265-2021-15881
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0027883047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/16/2021 Patient Sequence Number: 1