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

Lot Number 0024815173

Device Problem Activation Failure (3270)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  Injury  

Event Description

It was reported that a inadequate or insufficient apposition of a stent occurred.The target lesion was located in the ostium of the common trunk.A 4.00 x 8mm synergy megatron stent was advanced the target lesion and inflated at 14 atmospheres for 20 seconds, but it was noticed that the diameter of the stent was 40% below the normal size.The procedure was completed by placing another non bsc stent and no patient complications resulted in relation to this event.

Event Description

It was reported that a inadequate or insufficient apposition of a stent occurred.The target lesion was located in the ostium of the common trunk.A 4.00 x 8mm synergy megatron stent was advanced the target lesion and inflated at 14 atmospheres for 20 seconds, but it was noticed that the diameter of the stent was 40% below the normal size.The procedure was completed by placing another non bsc stent and no patient complications resulted in relation to this event.

Manufacturer Narrative

Summary of complaint investigation media review: in series 1 and 2 a severe lesion was evident in left main (lm) ostium.Pacing wires were evident in the heart.In series 3 lesion pre-dilation was carried out.When comparing the lesion before and after the pre-dilation, after pre-dilation the lesion still appeared to be severely narrowed.In series 4 the dilation balloon had been removed, and in series 5 and 6 an unexpanded stent was seen positioned across the ostial lm lesion site.In series 7 the stent was deployed, stent delivery balloon appeared fully expanded.In series 8 the stent delivery system had been removed and the deployed stent was evident in the vessel, the deployed stent was narrowed/constricted in the proximal region, conforming to the shape of the lesion.From series 9 to 14 it appeared that multiple post-dilations were carried out; what appeared to be inflated balloons were evident within the deployed stent in series 9, 12 and 14.In series 15 the balloon had been withdrawn into the guide catheter.Per the event description the procedure was completed using another stent (another manufacturers 4.0x8mm stent), while the introduction/positioning of this stent was not seen in the media one of the inflated balloon in series 9, 14 or 16 may have been the deployment of this stent.The post-dilations and/or deployment of the additional stent appeared to improve the narrowing/constriction which had been noted in the deployed stent.The final 3 series showed views of the final result, flow had been improved in the lm ostium with some narrowing and the lesion shape still evident.

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10934477
• MDR Text Key: 219150347
• Report Number: 2134265-2020-16422
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Lot Number: 0024815173
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention