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

Lot Number 0029995435

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.Synergy megatron mr ous 4.00 x 16mm stent delivery system (sds), catheter batch was returned to the complaint investigation site (cis).No issues were noted with the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.No stent was attached.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture.Balloon cones were reviewed and was subjected to positive pressure.Bumper tip showed no signs of distal tip damage.

Event Description

Reportable based on device analysis completed on 23-feb-2024.It was reported that crossing difficulties were encountered.The stenosed target lesion was located in the severely calcified left anterior descending artery.A 4.00 x 16mm synergy megatron drug eluting stent was advanced into the lesion but failed to cross.The device was removed, and the procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed a stent dislodgement.

• 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: 18932290
• MDR Text Key: 338135759
• Report Number: 2124215-2024-15985
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: KS
• 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
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0029995435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• 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: 66 YR
• Patient Sex: Male