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

Lot Number 0030435978

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.A synergy xd 3.50 x 32mm was selected for use during a percutaneous coronary intervention.During preparation for the procedure, when the physician attempted to remove the stent protector, it could not be removed.More force was used to remove the protector which caused the proximal end of the stent to become damaged.Because this stent was outside the patient at the time of damage occurring, another stent was opened and used to complete the procedure successfully.No patient complications resulted due to this event.It was later reported that the stent shaft broke during preparation without any manipulation from the physician.

Manufacturer Narrative

The returned product consisted of the synergy xd stent delivery system.Visual and microscopic examination showed a break at the guidewire exit port along the polymer extrusion.There were no signs of damage showed on the distal tip.It is likely that the unreported break in the polymer extrusion, located at the guidewire exit port occurred due to unintentional handling error during unpacking as it is indicative of excessive force being applied to the delivery system during removal from the coil.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• MDR Report Key: 18716221
• MDR Text Key: 336185269
• Report Number: 2124215-2024-09018
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0030435978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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