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

Model Number	H7493941832250
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break, insufficient stent apposition, and device explantation occurred.The 90% in-stent restenosis target lesion was located in the severely tortuous and severely calcified left anterior descending.There was difficulty with maintaining access during procedure and had difficulties delivering unknown boston scientific balloon catheters.A guidezilla extension catheter was used to help facilitate delivery and maintain access with guiding catheter.After multiple attempts at pre dilating the physician decided to stent.A 2.50 x 32mm synergy xd stent was advanced for treatment after some struggle to get the stent where it was needed.The physician inflated the balloon of the stent delivery system (sds) at 18 atmospheres.However, there was an area in the distal portion of the stent that looked to be under deployed.After deflating the sds, the physician tried to remove the sds but had resistance.Multiple attempts were made at removing the sds which resulted in the fracturing and dislodgment of the polymer portion of the sds.The hypotube portion of the sds was removed from the guide and the balloon portion of the sds remained in the patient's coronary artery (lad).Following consulting the cardiovascular surgery team, the decision was made to take the patient to surgery and remove the portion of the sds.The remanent stent balloon and under deployed stent had to be removed from the lad.Procedure performed on the patient resulted in a redo bypass of the lima to lad.The patient came out of surgery doing well and was being extubate shortly.The patient is resting comfortable and will make a solid recovery.There were no further patient complications and the patient was fully recovered.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16315824
• Report Number: 2124215-2023-04778
• Device Sequence Number: 8098800
• Product Code: NIQ
• UDI-Device Identifier: 08714729980841
• UDI-Public: 08714729980841
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 02/07/2023

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: 07/07/2023
• Device Model Number: H7493941832250
• Device Lot Number: 0027688503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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 Age: 83 YR
• Patient Sex: Male
• Patient Race: White