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

Model Number 10632

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

It was reported that stent fracture occurred.Vascular access was obtained via the radial artery.The 90% stenosed, 48mm x 3mm, eccentric, de novo target lesion with a bend of >45 degrees was located in the severely calcified left anterior descending artery.A 3.00 x 48 synergy drug-eluting stent was selected for treatment.However, during the procedure, the stent is failing with some loosened and shredded meshes.The device was removed, and the procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: synergy ous mr 3.00 x 48 was returned for analysis.A visual and tactile inspection identified no issues with the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.A visual and microscopic inspection of the stent identified stent struts lifted in the proximal section.A dimensional testing of the undamaged crimped stent od (outer diameter) was measured and the result was within max crimped stent profile measurement.A microscopic inspection of 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.The bumper tip showed signs of distal tip damage.No other device issues were identified during returned product analysis.

Event Description

It was reported that stent fracture occurred.Vascular access was obtained via the radial artery.The 90% stenosed, 48mm x 3mm, eccentric, de novo target lesion with a bend of >45 degrees was located in the severely calcified left anterior descending artery.A 3.00 x 48 synergy drug-eluting stent was selected for treatment.However, during the procedure, the stent is failing with some loosened and shredded meshes.The device was removed, and the procedure was completed with a different device.There were no patient complications reported.

• Brand Name: SYNERGY
• 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: 18862772
• MDR Text Key: 337665488
• Report Number: 2124215-2024-11144
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: MO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0030898729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 92 KG