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

Lot Number 0029946355

Device Problem Fracture (1260)

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

Event Date 11/14/2023

Event Type  Injury  

Event Description

It was reported that stent fracture occurred requiring additional intervention.Vascular access was obtained via the radial artery.The 90% stenosed, eccentric, de novo, 4.00 x 10mm, target lesion was located in the moderately tortuous and moderately calcified protected ostial left main artery.The lesion involved a significant bend between 45 and 90 degrees.Following pre-dilation with a 3.00 non-boston scientific (non-bsc) balloon at 16 atm, residual stenosis was 60%.A 4.00 x 12 mm synergy megatron drug-eluting stent was introduced, and significant resistance was encountered while advancing the device to the target lesion.During stent deployment, the stent suddenly partially fractured at 12 atm.The physician covered the fractured stent with a 4.00 x 8mm non-bsc stent and the procedure was completed.No patient complications were reported, and the patient status was stable.

• Brand Name: SYNERGY MEGATRON
• 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: 18240658
• MDR Text Key: 329400954
• Report Number: 2124215-2023-66441
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SN
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0029946355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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
• Treatment: GUIDE CATHETER: 6F JL 3; GUIDEWIRE: ASAHI SION BLUE
• Patient Outcome(s): Required Intervention