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

Device Problems Positioning Failure (1158); Inflation Problem (1310); Difficult to Remove (1528)

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

Event Date 09/22/2023

Event Type  Injury  

Event Description

It was reported that removal difficulty occurred resulting in surgery.The patient underwent a percutaneous coronary intervention on the proximal left anterior descending (lad) artery.A 4.00 x 12mm synergy megatron was advanced for treatment.While attempting to deploy, the stent watermelon seeded back over the guide catheter.The stent then got stuck in the sheath when trying to remove the under deployed stent.The patient was sent to surgery and has fully recovered.

Event Description

It was reported that removal difficulty occurred resulting in surgery.The patient underwent a percutaneous coronary intervention on the proximal left anterior descending (lad) artery.A 4.00 x 12mm synergy megatron was advanced for treatment.While attempting to deploy, the stent watermelon seeded back over the guide catheter.The stent then got stuck in the sheath when trying to remove the under deployed stent.The patient was sent to surgery and has fully recovered.It was further reported that the lesion was located in the proximal to mid left main (lm) artery.The lesion site was prepared using plain old balloon angioplasty.The distal tip of the guide catheter was not engaged in the lm artery.When the physician attempted to place the stent in the lm and inflate the stent delivery balloon, the stent slipped out of the lm.The stent could not be pulled back into the guide catheter since the guide catheter was not engaged.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18022711
• MDR Text Key: 326748090
• Report Number: 2124215-2023-59200
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention