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

Lot Number 0026123072

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

Event Description

It was reported that removal difficulties and slow deflation occurred. The 100% stenosed target lesion was located in mildly tortuous and moderately calcified vessel. A synergy xd drug-eluting stent was advanced for treatment. However, during procedure, it was noted that the deflation time of the balloon in stent was slow and did not change after the contrast concentration was changed. The stent was deployed and the balloon was sticky when exiting a stent. Removal of the balloon from the stent caused the guide catheter to move forward into the left main. There were no patient complications nor injuries reported.

• Brand Name: SYNERGY XD
• 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: 11296424
• MDR Text Key: 230952884
• Report Number: 2134265-2021-00933
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 0026123072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial