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

Lot Number 0031995126

Device Problems Break (1069); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The stenosed target lesion was located in the non-tortuous and non-calcified left anterior descending artery.A 3.50 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, when the physician attempted to advance the device, a resistance was felt, and the mid shaft was kinked and broke.The device was removed intact from the patient's body.The procedure was completed with another of the same device.There were 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: 18373155
• MDR Text Key: 331109802
• Report Number: 2124215-2023-72478
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981046
• UDI-Public: 08714729981046
• 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: 12/21/2023

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 Lot Number: 0031995126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• 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