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

Lot Number 0028509208

Device Problems Break (1069); Material Deformation (2976); Failure to Deflate (4060)

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

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

B5: describe event or problem: updated to include new information obtained.E1: initial reporter address 1: genesis healthcare system 955 bethesda dr.

Event Description

It was reported that a shaft break and balloon deflation issues occurred.The patient underwent renal artery stenting.A 5.00 x 12mm synergy xd drug-eluting stent was advanced for treatment and was deployed at 12 atmospheres for 30 seconds.However, the shaft was kinked slightly upon insertion.Post stent implantation, the balloon failed to deflate.When the device was removed, the shaft broke off.The device was trapped inside of the guide catheter and the entire system was removed fully deflated.The procedure was completed, with no patient complications reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17390705
• MDR Text Key: 319804880
• Report Number: 2124215-2023-35893
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981244
• UDI-Public: 08714729981244
• 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: Physician
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2023
• Device Lot Number: 0028509208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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