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

Model Number 10616

Device Problem Device Damaged by Another Device (2915)

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

Event Date 02/04/2022

Event Type  malfunction  

Event Description

It was reported that stent damage post deployment occurred.Vascular access was obtained via the radial artery.The 8mmx4mm, target lesion was located in the non-tortuous ostial left main coronary artery.After predilation was performed, a 4.00 x 8 synergy drug-eluting stent was deployed for treatment.However, after post dilation with a 4.50 balloon, imaging revealed struts of the stent were fractured.Angiography and intravascular ultrasound were done and the stent was left implanted in the patient with no further actions taken.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that stent damage post deployment occurred.Vascular access was obtained via the radial artery.The 8mmx4mm, target lesion was located in the non-tortuous ostial left main coronary artery.After pre-dilation was performed, a 4.00 x 8 synergy drug-eluting stent was deployed for treatment.However, after post dilation with a 4.50 balloon, imaging revealed struts of the stent were fractured.Angiography and intravascular ultrasound were done and the stent was left implanted in the patient with no further actions taken.There were no patient complications reported and the patient status was stable.It was further reported that pre and post intravascular ultrasound (ivus) imaging of the target lesion was done and minimal calcification was found.The synergy stent was post dilated and apposition was checked using ivus.After deformities were found, computed tomography angiography (cta) was performed which revealed stent struts seemed to be broken.The physician decided that as the flow remained, no attempt would be made to snare or remove the stent.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13588643
• MDR Text Key: 286131116
• Report Number: 2134265-2022-01616
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: TC
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2023
• Device Model Number: 10616
• Device Catalogue Number: 10616
• Device Lot Number: 0027345842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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: 57 YR