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

Model Number 10621

Device Problems Fracture (1260); Defective Device (2588); Device-Device Incompatibility (2919)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  Injury  

Event Description

It was reported that post deployment a stent fracture occurred.The target lesion was located in the mid left anterior descending artery (lad).A 3.50 x 28 synergy ii drug eluting stent was advanced and deployed in the mid lad.A 4.5 nc balloon was advanced to post dilate the target lesion, but it appeared to have caused a fracture.The procedure was completed with a non boston scientific stent.No patient complications were reported in relation to this event and the patient was reported to be stable following the procedure.

Manufacturer Narrative

Media analysis: the device was not returned for analysis.Angiographic media and 2 optical coherence tomography (oct) videos were retuned for analysis.The images provided are consistent with stent disruption but not complete stent fracture.Tissue prolapse through a gap in stent cell architecture was observed with oct imaging.The stent cells may have shifted (elongated) or a strut separated during post dilation expansion.Expansion of the stent from 3.5 mm to 4.5 mm on a hinge point may have contributed to the stent architecture disruption.Stent deformation including fracture requiring additional stent placement are included in the synergy risk management documentation.

Event Description

It was reported that post deployment a stent fracture occurred.The target lesion was located in the mid left anterior descending artery (lad).A 3.50 x 28 synergy ii drug eluting stent was advanced and deployed in the mid lad.A 4.5 nc balloon was advanced to post dilate the target lesion, but it appeared to have caused a fracture.The procedure was completed with a non boston scientific stent.No patient complications were reported in relation to this event and the patient was reported to be stable following the procedure.It was further reported that an oct walkthrough of the stented segment was completed which confirmed that it was a non uniform expansion, not fracture, with tissue prolapse.No further patient complications were reported in relation to this event.

• 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: 11314577
• MDR Text Key: 231393639
• Report Number: 2134265-2021-01613
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2022
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0025855234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention