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

Lot Number 0028326069

Device Problem Difficult to Advance (2920)

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

Event Date 05/17/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 31-jan-2024.It was reported that the stent balloon catheter was difficult to advance.A 5.00 x 12mm synergy stent balloon expandable was selected for use.The balloon was not able to fit into the non-bsc guide catheter.No further information is available.However, returned device analysis revealed the stent balloon catheter was stuck on the wire.

Manufacturer Narrative

Device evaluated by manufacturer: the returned product consisted of the synergy xd mr ous 5.00 x 12mm device, tracked over a guidewire and inserted through a guide catheter.A visual, tactile microscopic and device to device interaction examination of the returned device was performed.Device analysis confirmed that the device was stretched down onto the guidewire which prevented the movement of the device over the wire.Just the distal section of the balloon and tip was exiting from the tip of the guide catheter.No damage was observed to the balloon however, the balloon was not tightly folded.The tip did not exhibit any signs of damage however, the inner/wire lumen was stretched.The device could not be removed or advanced through the guide.Attempts to pull a vacuum to try and tighten the balloon folds failed, consistent with stretching in the distal extrusion.The device was trapped in the guide catheter.

• 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: 18705754
• MDR Text Key: 336422283
• Report Number: 2124215-2024-06917
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2024

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: 10/20/2023
• Device Lot Number: 0028326069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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
• Treatment: LAUNCHER GUIDE, MEDTRONIC GUIDE CATHETER.