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

Model Number H7493941832400

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Failure to Deflate (4060)

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

Event Date 04/06/2023

Event Type  Injury  

Event Description

It was reported that deflation issues occurred.A 12mm x 2.50mm nc quantum apex and a 4.00 x 32mm synergy xd were selected for use.During the procedure, after the stent was successfully delivered and expanded, it was noted that the balloon got stuck in the guide.Another inflation device was used in an attempt to fully deflate the balloon, but it remained stuck in the guide, so a wire was used to pop and further deflate the balloon.Next the nc balloon got stuck in the guide after deflation and the nc balloon was also popped to further deflate.The balloon was removed and the procedure was completed successfully.There were no patient complications.

Event Description

It was reported that deflation issues occurred.A 12mm x 2.50mm nc quantum apex and a 4.00 x 32mm synergy xd were selected for use.During the procedure, after the stent was successfully delivered and expanded, it was noted that the balloon got stuck in the guide.Another inflation device was used in an attempt to fully deflate the balloon, but it remained stuck in the guide, so a wire was used to pop and further deflate the balloon.Next the nc balloon got stuck in the guide after deflation and the nc balloon was also popped to further deflate.The balloon was removed and the procedure was completed successfully.There were no patient complications.

Manufacturer Narrative

H6 device codes: corrected.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16809412
• MDR Text Key: 313946492
• Report Number: 2124215-2023-19072
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981169
• UDI-Public: 08714729981169
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493941832400
• Device Lot Number: 0029995432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/05/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention