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

Model Number 10623

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

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

Event Date 01/03/2022

Event Type  malfunction  

Manufacturer Narrative

The synergy ous mr 3.00 x 38mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts in the proximal region were found to be lifted from their crimped position and pulled distally.The undamaged crimped stent outer diameter was measured and the result is within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube identified multiple hypotube kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues.The device was successfully loaded onto a 0.014 inch guidewire with no issues noted.

Event Description

It was reported that stent damage occurred.The target lesion was located in the severely calcified diagonal and left circumflex arteries.A 3.00 x 38 synergy drug-eluting stent was introduced but had difficulty advancing over the guidewire.The device was removed and found to be kinked in the stent.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14148986
• MDR Text Key: 289693574
• Report Number: 2134265-2022-04331
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0026940895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• 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: GUIDE CATHETER: XB 3.5