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

Model Number 10623

Device Problems Entrapment of Device (1212); Material Deformation (2976)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported that device entrapment occurred.The 90% stenosed target lesion was located in the mildly tortuous left circumflex coronary artery.A 2.75 x 38mm synergy xd drug eluting stent was advanced for treatment while using the non-bsc guide catheter extension to access the lesion.Physician successfully reach the lesion; however, the stent got stuck in the guide catheter extension which causes the stent to be damaged while deploying.The stent was simply removed and completed the procedure with a different device.There were no patient complications reported.

Event Description

It was reported that device entrapment occurred.The 90% stenosed target lesion was located in the mildly tortuous left circumflex coronary artery.A 2.75 x 38mm synergy xd drug eluting stent was advanced for treatment while using the non-bsc guide catheter extension to access the lesion.Physician successfully reach the lesion; however, the stent got stuck in the guide catheter extension which causes the stent to be damaged while deploying.The stent was simply removed and completed the procedure with a different device.There were no patient complications reported.

• Brand Name: SYNERGY
• 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 SCIMED, INC; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18455232
• MDR Text Key: 332282552
• Report Number: 2124215-2023-73513
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 03/02/2024
• Supplement Dates FDA Received: 03/19/2024
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian