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

Lot Number 0028391612

Device Problems Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

It was reported that the stent moved on balloon.The patient presented for percutaneous coronary intervention (pci) of the target lesion located in the right coronary artery (rca) ostium.A 4.00 x 32mm synergy megatron drug-eluting stent was advanced for treatment.However, before deploying the stent, the physician noticed that the distance between the distal marker and stent edge versus the proximal marker and proximal stent edge were not the same, and the physician had a hard time deploying the stent.The procedure was completed successfully.No patient complications were reported.

Manufacturer Narrative

Initial reporter address 2: (b)(6).

Manufacturer Narrative

E1 - initial reporter address 2: (b)(6).The device was not returned for analysis; therefore, a technical analysis could not be performed.An image provided by the site was examined by boston scientific medical personal.Based on their assessment, the image was consistent with the reported event.The inconsistent markerband gap lengths were likely caused by megatron movement on the stent delivery system (sds) during delivery to the target lesion.

Event Description

It was reported that the stent moved on balloon.The patient presented for percutaneous coronary intervention (pci) of the target lesion located in the right coronary artery (rca) ostium.A 4.00 x 32mm synergy megatron drug-eluting stent was advanced for treatment.However, before deploying the stent, the physician noticed that the distance between the distal marker and stent edge versus the proximal marker and proximal stent edge were not the same, and the physician had a hard time deploying the stent.The procedure was completed successfully.No patient complications were reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16735501
• MDR Text Key: 313247685
• Report Number: 2124215-2023-16498
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: MY
• 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,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Lot Number: 0028391612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian