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

Model Number 10623

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

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

Event Date 03/31/2023

Event Type  Injury  

Event Description

It was reported that stent fracture occurred requiring additional information.The patient presented with blockage of the coronary artery and underwent percutaneous transluminal coronary angioplasty.The more than 90% stenosed target lesion was located in the mildly tortuous and mildly calcified proximal right coronary artery.A 3.00 x 38 synergy drug-eluting stent (des) was advanced for treatment.Post deployment, the physician inserted a guide catheter deep to take the post-dilatation balloon.However, the proximal edge of the stent was hit with the deep seeded guide catheter, and the stent struts were fractured proximally.Another 3.0 x 20mm synergy des was then deployed to cover the fractured portion of the stent and the procedure was completed.No patient complications were reported, and the patient's status was stable.

Manufacturer Narrative

A review was conducted of procedural media received from the site.The review could not identify the alleged stent fracture however stent strut displacement and deformation was noted in the mid to proximal region of the stent which could have appeared to the physician as stent fracture.The displaced struts visible in the photo review most likely represent a stent deformation induced by a possible interaction of the deployed stent with ancillary devices used during the procedure such as the distal end of the guide catheter.

Event Description

It was reported that stent fracture occurred requiring additional information.The patient presented with blockage of the coronary artery and underwent percutaneous transluminal coronary angioplasty.The more than 90% stenosed target lesion was located in the mildly tortuous and mildly calcified proximal right coronary artery.A 3.00 x 38 synergy drug-eluting stent (des) was advanced for treatment.Post deployment, the physician inserted a guide catheter deep to take the post-dilatation balloon.However, the proximal edge of the stent was hit with the deep seeded guide catheter, and the stent struts were fractured proximally.Another 3.0 x 20mm synergy des was then deployed to cover the fractured portion of the stent and the procedure was completed.No patient complications were reported, and the patient's status was stable.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16765628
• MDR Text Key: 313541812
• Report Number: 2124215-2023-16653
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0030040211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: Asian