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

Model Number 10632

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage post-deployment occurred.The target lesion was located in the left main artery.Following pre-dilation, a 3.50 x 48 synergy drug-eluting stent was deployed to treat the lesion.However, a strut longitudinal deformation was noted.Another synergy stent was then used to complete the procedure.No further patient complications were reported and the patient is ok.

Manufacturer Narrative

Procedural media (in the form of a 10 minutes and 47 seconds video recording) was returned for analysis.A review of the images received noted the distal end of the guidecatheter with 2 guidewires on through left main (lm) to left anterior descending artery (lad) and one through left circumflex artery (lcx).Balloon predilation was performed at the lesion site identified in lm-lad as diminished flow can be noted in that region.A stent was seen being deployed in mid lad to the ostium of the lm.Post dilation followed with 2 balloon sizes and constrictions could be noted in the lm region of the lesion suggesting that calcified regions are still present throughout the lesion.The review of the media provided could not identify the alleged strut longitudinal deformation as no strut displacement can be noted on the first deployed stent.However, regions of calcification can be noted throughout the lm region post stent deployment and post-dilations and these could have led the physician to believe that stent damage/elongation occurred.The stent structure appeared normal, without any struts noted to be out of place (or missing) and conformed to the vessel anatomy.

Event Description

It was reported that stent damage post-deployment occurred.The target lesion was located in the left main artery.Following pre-dilation, a 3.50 x 48 synergy drug-eluting stent was deployed to treat the lesion.However, a strut longitudinal deformation was noted.Another synergy stent was then used to complete the procedure.No further patient complications were reported and the patient is ok.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10273867
• MDR Text Key: 198864331
• Report Number: 2134265-2020-09275
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0025085119
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR