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

Lot Number 0030917759

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

It was reported that stent moved on balloon occurred.The target lesion was located in the coronary artery.A 4.00 x 38mm synergy xd drug eluting stent (des) was advanced for dilatation.However, during the procedure, the stent partially shifted on the stent balloon prior to deployment.The device was removed from the patient's body successfully, and the procedure was completed with a different device.There were no patient complications reported.

Event Description

It was reported that stent moved on balloon occurred.The target lesion was located in the coronary artery.A 4.00 x 38mm synergy xd drug eluting stent (des) was advanced for dilatation.However, during the procedure, the stent partially shifted on the stent balloon prior to deployment.The device was removed from the patient's body successfully, and the procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

The device was returned for analysis.Visual and tactile revealed the proximal stent struts were damaged, they were bunched and pulled distally towards the mid-section of the balloon.A stent strut was partially lifted at the distal section of the stent.The device was returned attached to a guide catheter.Balloon cones were reviewed and were not subjected to positive pressure.Microscopic examination of the stent revealed stent struts pulled distally and bunched at the mid-section of the stent.Balloon cones were reviewed and were not subjected to positive pressure.Stent positioning revealed no signs of movement at the distal end, stent struts did not pass the distal markerband.Bumper tip showed no signs of distal tip damage.Dimensional testing revealed that the undamaged crimped stent od (outer diameter) was measured by snap gauge and the result was 0.0485 inch which is within max crimped stent profile measurement.

• 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: 18770199
• MDR Text Key: 336132636
• Report Number: 2124215-2024-10380
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981176
• UDI-Public: 08714729981176
• 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,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0030917759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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