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

Model Number	H7493941812450
Medical Device Problem Codes	Difficult to Remove (1528); Activation Failure (3270); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulty, stent not fully expanded, and 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
• Common Device Name: 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: 14504002
• Report Number: 2134265-2022-05365
• Device Sequence Number: 17554123
• Product Code: NIQ
• UDI-Device Identifier: 08714729981183
• UDI-Public: 08714729981183
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2023
• Device Model Number: H7493941812450
• Device Lot Number: 0028138657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female