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

Model Number 10620

Device Problems Fracture (1260); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter phone: (b)(6).

Event Description

It was reported that a stent fracture occurred.The occluded target lesion was located in the tortuous and calcified left anterior descending artery.A 3.50 x 24 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the stent failed to cross the lesion and fractured.The procedure was completed with a different device.No patient complications were reported, and the patient was stable.

Manufacturer Narrative

B5 - describe event or problem: updated to include new information obtained h6 - coding updated per new information obtained.E1: initial reporter phone: (b)(6).

Event Description

It was reported that a stent fracture occurred.The occluded target lesion was located in the tortuous and calcified left anterior descending artery.A 3.50 x 24 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the stent failed to cross the lesion and fractured.The procedure was completed with a different device.No patient complications were reported, and the patient was stable.It was further reported that stenosed target lesion was 60-70%.Following pre-dilatation of a balloon, the stent was deployed with the same size standard pressure deployment.However, there was no indication that the stent broke into two pieces.

• 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: 19035111
• MDR Text Key: 339279741
• Report Number: 2124215-2024-20185
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0030756746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 72 KG