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

Device Problem Migration (4003)

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

Event Date 05/02/2022

Event Type  Injury  

Event Description

It was reported that stent migration occurred.The 80% stenosed target lesion was located in the moderate to severely tortuous and non- to mildly calcified proximal circumflex artery.No lesion preparation was performed.A 4.50 x 16mm synergy xd drug-eluting stent (des) was advanced for treatment.The stent was inflated at 11 atmospheres (atm) for 20 seconds and appeared normal and expanded.The stent was placed; however, the stent shifted distal to the lesion.Another 4.50 x 12mm synergy xd des was advanced to cover the missed lesion and was inflated at 12 atm for 20 seconds.Prior to removal, the balloon was deflated; however, when the physician tried to remove the balloon catheter, there was resistance.The inflation device was checked to confirm it was down and the doctor pulled to get the catheter out.After removal, it was noticed that the stent itself pulled back into the left main artery, and the distal edge of the stent appeared to be not fully expanded and also was now proximal to the lesion.Subsequently, another 5.0x12 synergy xd des was advanced and inflated at 16 atmospheres for 10 seconds to put between the 2 stents and "tacked" everything down.A non-boston scientific balloon catheter was used to post dilate all and the procedure was completed successfully.Intravascular ultrasound confirmed there was no crushed or broken metal or other issues, and the end result was fine.There were no patient complications reported.

• Brand Name: SYNERGY XD
• 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: 14504054
• MDR Text Key: 292698591
• Report Number: 2134265-2022-05368
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Female